Coronary Arterial Disease (CAD)NCT07063277
Comparison of Oxygen Reserve Index and Spirometry in Predicting Respiratory Complications After Coronary Artery Bypass Surgery
A study testing Preoperative Evaluation with ORI and Spirometry in people with Coronary Arterial Disease (CAD) and Coronary Artery Bypass Graft (CABG), run by Ankara Bilkent Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
Coronary artery disease (CAD) is one of the most common cardiac conditions, primarily caused by atherosclerosis. Studies have shown that environmental factors such as lifestyle, diet, genetics, and air pollution contribute to the increasing prevalence of atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Coronary Artery Bypass Graft (CABG), Postoperative Pulmonary Complication
- What is being tested?
- Preoperative Evaluation with ORI and Spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective coronary artery bypass grafting (CABG) surgery.
- Aged 18 years or older at the time of enrollment.
- Provided written informed consent to participate in the study.
- Medically stable and cooperative for preoperative respiratory assessments (ORI and spirometry).
Who cannot join
- Refusal to participate or failure to provide informed consent.
- Age under 18 years.
- Left ventricular ejection fraction below 40% on preoperative evaluation.
- Presence of cognitive impairment or psychiatric disorders preventing cooperation (e.g., dementia, Alzheimer's disease).
- Severe anemia defined as hemoglobin level below 8 g/dL.
- Undergoing emergency surgery rather than elective CABG.
- Anatomical or mechanical obstruction that may impair nasal oxygenation (e.g., severe nasal septum deviation, presence of a nasogastric tube).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Diagnostic Value of the Oxygen Reserve Index (ORI) and Spirometry Tests in Predicting Postoperative Respiratory Complications in Patients Undergoing Coronary Artery Bypass Surgery
Coronary artery disease (CAD) is one of the most common cardiac conditions, primarily caused by atherosclerosis. Studies have shown that environmental factors such as lifestyle, diet, genetics, and air pollution contribute to the increasing prevalence of atherosclerosis. Despite advances in non-invasive and medical therapies, coronary artery bypass grafting (CABG) remains a definitive treatment in many cases. CABG is commonly performed using cardiopulmonary bypass (CPB), which increases the risk of additional complications. Among postoperative complications, pulmonary events are the most frequent and are closely associated with increased morbidity and mortality.
Postoperative pulmonary complications (PPCs) significantly raise healthcare costs, prolong hospital stays, and worsen patient outcomes. Cardiac surgery increases susceptibility to PPCs through factors such as sternotomy, CPB, myocardial protection via hypothermia, and phrenic nerve injury. These factors impair thoracic compliance, diaphragm movement, and mucociliary function. Mechanical ventilation further contributes through inflammatory responses that may cause barotrauma and volutrauma.
Read more
The incidence of PPCs varies from 1.96% to 43.7%, depending on patient characteristics, surgical type, and diagnostic criteria. With an aging population and more high-risk patients undergoing surgery, the incidence of PPCs is expected to rise. Reported preoperative risk factors include advanced age, active or recent smoking, BMI >25, heart failure, prior myocardial infarction, chronic lung disease, type 2 diabetes mellitus, hypertension, and ASA score >2. Intraoperative factors include prolonged anesthesia, CPB duration >95 minutes, multiple grafts, and use of the internal mammary artery. Postoperative contributors include prolonged ventilation, nasogastric tube use, and insufficient nursing care.
Common PPCs include atelectasis, pneumonia, bronchospasm, pulmonary embolism, pleural effusion, acute respiratory distress syndrome (ARDS), pneumothorax, hemothorax, and transfusion-related acute lung injury (TRALI). Atelectasis is observed in 30-72% of cases on postoperative chest X-rays. TRALI is the leading cause of transfusion-related death and is characterized by hypoxia and bilateral pulmonary infiltrates. Pleural effusions are associated with low BMI, female sex, atrial fibrillation, heart failure, valve surgery, and anticoagulant use. Phrenic nerve injury, often resulting from internal thoracic artery dissection or cold-induced damage during myocardial protection, leads to unilateral diaphragmatic dysfunction.
Hospital-acquired infections, particularly pneumonia, are among the most common and costly non-cardiac complications following cardiac surgery. Pneumonia occurs in 2.4%-20% of cases, while ventilator-associated pneumonia affects 35.2% of patients intubated longer than 48 hours. ARDS is the most severe PPC, involving widespread alveolar injury, endothelial disruption, and non-cardiogenic pulmonary edema. Tension pneumothorax may also occur after chest tube removal.
Spirometry is a standard preoperative test used to assess lung function, primarily through FEV₁ and FVC values. These measurements help detect obstructive or restrictive defects. FEV₁/FVC <70% has been identified as an independent risk factor for PPCs. However, spirometry's predictive value is limited. A systematic review by Dankert et al. reported sensitivities ranging from 38% to 84% and specificities from 55% to 99%. Combined data yielded a sensitivity of 62%, specificity of 70%, and an area under the curve (AUC) of 0.74.
Pulse oximetry alone cannot reliably indicate PaO₂ above 100 mmHg or provide information on oxygen reserve. The Oxygen Reserve Index (ORI) is a novel, continuous, and non-invasive parameter that evaluates oxygenation status in the mild hyperoxic range (PaO₂ 100-200 mmHg). ORI values range from 0.00 to 1.00 and correlate with changes in PaO₂. ORI >0.24 corresponds to PaO₂ ≥100 mmHg when SpO₂ exceeds 98%, while ORI >0.55 may indicate PaO₂ ≥150 mmHg. A declining ORI trend approaching 0.24, despite SpO₂ >98%, can signal impending hypoxemia.
Given the substantial impact of PPCs on postoperative outcomes and the limitations of spirometry in accurately predicting these complications, there is a need for more reliable preoperative assessment tools. The present study aims to compare the diagnostic performance of the Oxygen Reserve Index and spirometry in predicting postoperative respiratory complications in patients undergoing coronary artery bypass surgery. The goal is to identify a more accurate and effective method for preoperative pulmonary risk stratification.
Read the detailed description
Coronary artery disease (CAD) is one of the most prevalent cardiac disorders caused by atherosclerosis. Comprehensive studies have shown that changes in environmental factors such as lifestyle, diet, genetics, and air pollution contribute to an increased incidence of atherosclerosis. Despite the continuous development of non-invasive and medical treatments, coronary artery bypass grafting (CABG) remains the final treatment option for many patients. In this procedure, open-heart surgery is performed with or without the use of cardiopulmonary bypass (CPB), during which vascular grafts are created. In most cases, CPB is utilized, which may lead to additional complications beyond those associated with the surgery itself. Following CABG, cardiovascular, pulmonary, renal, infectious, and psychiatric complications may occur. Among these, pulmonary complications are the most commonly encountered and are significantly associated with morbidity and mortality.
Postoperative pulmonary complications (PPCs) following cardiac surgery increase healthcare costs, prolong hospital stay, and elevate morbidity and mortality rates. Cardiac surgery predisposes to PPCs more than other surgical types due to median sternotomy/thoracotomy, CPB, myocardial protection via hypothermia, and phrenic nerve injury. It directly impairs thoracic compliance, diaphragm function, and mucociliary clearance. Additionally, mechanical ventilation activates local and systemic inflammatory responses, leading to volutrauma and barotrauma.
The incidence of PPCs following cardiac surgery ranges from 1.96% to 43.7%, depending on patient-related risk factors, the type of cardiac procedure performed, and the definition of PPC used. With the increasing number of high-risk patients undergoing cardiac surgery due to an aging population, a rise in PPC incidence is expected. Preoperative risk factors identified in various studies include age above 65 or 80 years, active smoking within the past 6 or 12 months, body mass index over 25, heart failure, history of myocardial infarction (MI), chronic lung disease, type 2 diabetes mellitus (DM2), hypertension (HT), and an American Society of Anesthesiologists (ASA) score greater than 2. Intraoperative risk factors include anesthesia duration longer than 270 minutes, CPB duration longer than 95 minutes, repair of four or more vessels, and use of the internal mammary artery (IMA) as a graft. Postoperative risk factors include mechanical ventilation for more than 10 hours, presence of a nasogastric tube, and lack of high-quality nursing care.
PPCs include atelectasis, pneumonia, bronchospasm, pulmonary embolism, pleural effusion, acute respiratory distress syndrome (ARDS), pneumothorax, hemothorax, mechanical ventilation longer than 48 hours, transfusion-related acute lung injury (TRALI), and phrenic nerve injury. Atelectasis is a common cause of hypoxemia and impaired gas exchange following cardiac surgery. Postoperative chest X-rays show atelectasis in 30-72% of patients, making it one of the leading causes of respiratory dysfunction. TRALI is the most common transfusion-related adverse event and the leading cause of transfusion-related deaths globally. It is characterized by acute hypoxia and bilateral pulmonary infiltrates following allogeneic blood transfusion. Pleural effusions after CABG are associated with low body mass index, female sex, history of atrial fibrillation, heart failure, concomitant valve surgery, and anticoagulant use. Surgical injury to the phrenic nerve often results in unilateral loss of diaphragmatic function and is commonly observed during dissection of the internal thoracic artery. Previous studies have shown that phrenic nerve injury may also occur due to cold exposure during myocardial protection strategies.
Healthcare-associated infections are a leading cause of non-cardiac morbidity after cardiac surgery. Among these, pneumonia is the most frequently observed, the most expensive, and the most resource-intensive infection. Pneumonia develops in 2.4% to 20% of patients following cardiac surgery. Additionally, ventilator-associated pneumonia occurs in 35.2% of patients who remain on mechanical ventilation for more than 48 hours. ARDS is the most severe pulmonary complication after cardiac surgery, characterized by pro-inflammatory injury to the alveolar structure, widespread endothelial damage, severe hypoxia, and non-cardiogenic pulmonary edema.
Mediastinal and pleural drains are commonly placed after cardiac surgery and are removed when fluid output is minimal and hemodynamic stability is achieved. However, recurrence due to tension pneumothorax following drain removal represents a life-threatening complication. This occurs when a one-way air flow between the lung parenchyma and the pleural space causes air to become trapped in the pleural cavity.
Spirometry is used to assess pulmonary function and is a widely accepted preoperative test in thoracic surgeries. It evaluates the forced expiratory volume in one second (FEV₁) and forced vital capacity (FVC), aiding in the diagnosis of obstructive or restrictive ventilatory defects. Spirometry is closely associated with chronic obstructive pulmonary disease (COPD), asthma, and interstitial lung diseases. An FEV₁/FVC ratio below 70% is considered an independent risk factor for postoperative complications in thoracic surgeries.
Although spirometry is a conventional respiratory function test, its sensitivity and specificity in predicting PPCs remain suboptimal. A systematic review by Dankert et al. reported sensitivities ranging from 38% to 84% and specificities from 55% to 99%. Based on the pooled data from the included studies, a ROC analysis was performed to assess spirometry's predictive value for PPCs. The average sensitivity was found to be 62%, specificity 70%, and area under the curve (AUC) 0.74.
While pulse oximetry is a standard monitoring tool, it does not reliably indicate whether PaO₂ exceeds 100 mmHg or whether oxygen reserves are increasing. Therefore, the Oxygen Reserve Index (ORI) may assist in identifying inadequate preoxygenation and provide preliminary information on pulmonary oxygen reserve. ORI is a non-invasive and continuous parameter that evaluates real-time oxygen reserve within a mild hyperoxic range (approximately PaO₂ 100-200 mmHg). It is measured using a finger sensor and varies between 0.00 and 1.00 depending on oxygen reserve status. Changes in ORI values reflect corresponding changes in PaO₂ within this range. Although ORI and PaO₂ do not show exact correspondence, a positive correlation has been observed within the specified range. Studies have shown that when SpO₂ exceeds 98%, an ORI >0.24 may indicate PaO₂ ≥100 mmHg. Similarly, an ORI >0.55 appears to correspond with PaO₂ ≥150 mmHg. A decline in ORI toward 0.24 while SpO₂ remains >98% may serve as an early indicator of PaO₂ approaching 100 mmHg.
Given the high morbidity and mortality associated with PPCs, especially in cardiac surgery cases, accurate preoperative prediction and appropriate risk stratification are of critical importance. Due to the limited predictive power of spirometry alone, there is a need for novel and updated approaches. The current study aims to evaluate the effectiveness of ORI and spirometry in predicting PPCs. Based on the findings, a more effective method for anticipating pulmonary complications in cardiac surgery may be developed.
- Conditions
- Coronary Arterial Disease (CAD), Coronary Artery Bypass Graft (CABG), Postoperative Pulmonary Complication
- Being tested
- Preoperative Evaluation with ORI and Spirometry
- Keywords
- Postoperative Pulmonary Complications, Coronary Artery Bypass Grafting, Oxygen Reserve Index, Spirometry, Cardiac Surgery Risk Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Evaluation with ORI and SpirometryDevice
All participants in this single-arm diagnostic study will undergo preoperative evaluation involving two non-invasive respiratory assessment methods: the Oxygen Reserve Index (ORI) and spirometry. ORI will be measured using a multi-wavelength pulse co-oximetry sensor placed on the patient's fingertip. This sensor provides a continuous, real-time index (ranging from 0.00 to 1.00) that reflects the patient's oxygen reserve within a PaO₂ range of approximately 100-200 mmHg.
Spirometry will be performed using standard pulmonary function testing protocols. Each patient will be instructed to perform forced expiratory maneuvers to obtain parameters including forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), and the FEV₁/FVC ratio. These values will be recorded prior to surgery and interpreted according to internationally accepted reference ranges.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Evaluation with ORI and Spirometry | Experimental | All participants in this arm will undergo preoperative evaluation using two non-invasive methods: the Oxygen Reserve Index (ORI) and spirometry. ORI will be measured via a fingertip pulse co-oximetry sensor, reflecting oxygen reserve within the PaO₂ range of 100-200 mmHg. Measurements will be taken during routine preoxygenation with room air and supplemental oxygen. Spirometry will be conducted according to standard pulmonary function testing protocols and will include FEV₁, FVC, and FEV₁/FVC ratio. The aim is to assess and compare the predictive value of ORI and spirometry for identifying postoperative respiratory complications in patients undergoing coronary artery bypass grafting (CABG). No therapeutic intervention will be applied. Receives: Device: Preoperative Evaluation with ORI and Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Respiratory Complications
Postoperative respiratory complications, including but not limited to collapse of part or all of a lung (atelectasis), lung infection (pneumonia), the need for continued use of a breathing machine for an extended period after surgery (prolonged mechanical ventilation), or abnormalities in oxygen levels in the blood (oxygenation disorders), will be systematically assessed during the first 48 hours following the surgical procedure. Each event will be evaluated based on clinical symptoms such as shortness of breath, abnormal breath sounds, or decreased oxygen saturation. Additional confirmation will be obtained through diagnostic tools including chest imaging (such as chest X-ray), arterial blood gas analysis, and ventilator parameters. The presence, timing, and severity of each complication will be documented, as well as any medical or mechanical respiratory support required (such as supplemental oxygen, non-invasive ventilation, or reintubation)
Measured: Postoperative 48 hours
Secondary outcomes (8)
Preoperative Peak ORI Value
The highest Oxygen Reserve Index (ORI) value recorded during the preoxygenation phase will be measured using a multi-wavelength fingertip pulse co-oximetry sensor. The ORI value (ranging from 0.00 to 1.00) reflects the patient's oxygen reserve within a PaO₂ range of approximately 100-200 mmHg. This parameter will be used to investigate the association between preoperative oxygen reserve and the risk of postoperative respiratory complications.
Measured: Preoperative period (within 24 hours prior to surgery)
FEV₁ (Forced Expiratory Volume in 1 second)
The volume of air forcefully exhaled during the first second of a forced breath, measured preoperatively via standardized spirometry. FEV₁ serves as a primary indicator of airway obstruction and overall pulmonary function. Both absolute values and corresponding z-scores (adjusted for age, sex, height, and ethnicity) will be recorded to enable individualized interpretation and comparison. These values will be used to evaluate baseline pulmonary status and its association with postoperative respiratory complications.
Measured: Preoperative period (within 24 hours prior to surgery)
Intraoperative Respiratory Complications
Respiratory complications occurring intraoperatively will be documented in real-time by the anesthesia team. These may include bronchospasm, desaturation events (SpO₂ < 90%), unexpected need for endotracheal intubation, or intraoperative airway management difficulties. Each event will be classified according to timing, severity, and the intervention required.
Measured: During surgery
Intraoperative Hemodynamic or Surgical Complications
This outcome includes any intraoperative complications unrelated to the respiratory system, such as low blood pressure requiring the use of medications to support circulation (mean arterial pressure below 65 millimeters of mercury), abnormal heart rhythms, bleeding that requires transfusion of blood or blood products, technical difficulties during the connection of bypass grafts, or prolonged duration of the heart-lung machine use. All events will be categorized based on their type and severity.
Measured: During surgery
Duration of Intensive Care Unit and Total Hospital Stay
The total number of full calendar days each participant remains in the intensive care unit after surgery, as well as the total length of hospitalization from the date of surgery until discharge from the hospital, will be recorded. These durations will serve as indicators of early and overall postoperative recovery. The results will be analyzed in relation to preoperative respiratory assessments, including Oxygen Reserve Index and spirometry measurements. This outcome will also provide insight into healthcare resource utilization and patient stratification based on preoperative respiratory function.
Measured: From the date of surgery until ICU and hospital discharge, assessed up to 180 days
In-Hospital Postoperative Mortality
Any death occurring during the same hospital admission after the surgical procedure will be recorded and classified based on time of occurrence and primary cause. This outcome will be used to assess the relationship between baseline respiratory parameters and mortality risk.
Measured: From the date of surgery until hospital discharge, assessed up to 180 days
FVC (Forced Vital Capacity)
The total volume of air exhaled forcefully after a maximal inhalation, assessed through preoperative spirometry. FVC reflects pulmonary capacity and is essential in identifying restrictive ventilatory defects. Both raw FVC values and corresponding z-scores will be recorded. This parameter will contribute to assessing baseline lung mechanics and stratifying risk for postoperative respiratory dysfunction.
Measured: Preoperative period (within 24 hours prior to surgery)
PEF (Peak Expiratory Flow)
The maximum flow rate achieved during the forced expiratory maneuver, representing large airway patency and expiratory effort. PEF will be measured preoperatively using spirometry, with both raw values and z-scores recorded. It provides insight into expiratory muscle function and airway resistance, potentially correlating with postoperative respiratory recovery and complications.
Measured: Preoperative period (within 24 hours prior to surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start5 Jul 2025
- Primary completion12 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Bilkent Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Talha Daşgın, Ankara Bilkent Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063277
- Sponsor's protocol ID
- Ankara Bilkent City Hospital 2
- Other IDs
- TABED 1-25-1274
- Status last verified
- Feb 2026
- First submitted
- 25 Jun 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.
PubMed 28791567Chen ST, Min S. Oxygen reserve index, a new method of monitoring oxygenation status: what do we need to know? Chin Med J (Engl). 2020 Jan 20;133(2):229-234. doi: 10.1097/CM9.0000000000000625.
PubMed 31904726Dankert A, Dohrmann T, Loser B, Zapf A, Zollner C, Petzoldt M. Pulmonary Function Tests for the Prediction of Postoperative Pulmonary Complications. Dtsch Arztebl Int. 2022 Feb 18;119(7):99-106. doi: 10.3238/arztebl.m2022.0074.
PubMed 34939921Yoshimi K, Oh S, Suzuki K, Kodama Y, Sekiya M, Seyama K, Fukuchi Y. Impact of Airflow Limitation on Comorbidities and Postoperative Complications in Patients Undergoing Thoracic Surgery: A Retrospective Observational Study. Ann Thorac Cardiovasc Surg. 2016 Jun 20;22(3):146-52. doi: 10.5761/atcs.oa.15-00301. Epub 2016 Mar 1.
PubMed 26935262Park HJ, Kim SM, Kim HR, Ji W, Choi CM. The value of preoperative spirometry testing for predicting postoperative risk in upper abdominal and thoracic surgery assessed using big-data analysis. J Thorac Dis. 2020 Aug;12(8):4157-4167. doi: 10.21037/jtd-19-2687.
PubMed 32944327Tanner TG, Colvin MO. Pulmonary Complications of Cardiac Surgery. Lung. 2020 Dec;198(6):889-896. doi: 10.1007/s00408-020-00405-7. Epub 2020 Nov 11.
PubMed 33175990Jensen L, Yang L. Risk factors for postoperative pulmonary complications in coronary artery bypass graft surgery patients. Eur J Cardiovasc Nurs. 2007 Sep;6(3):241-6. doi: 10.1016/J.EJCNURSE.2006.11.001. Epub 2007 Mar 7.
PubMed 17347049Thanavaro J, Taylor J, Vitt L, Guignon MS, Thanavaro S. Predictors and outcomes of postoperative respiratory failure after cardiac surgery. J Eval Clin Pract. 2020 Oct;26(5):1490-1497. doi: 10.1111/jep.13334. Epub 2019 Dec 25.
PubMed 31876045Mali S, Haghaninejad H. Pulmonary complications following cardiac surgery. Arch Med Sci Atheroscler Dis. 2019 Dec 31;4:e280-e285. doi: 10.5114/amsad.2019.91432. eCollection 2019.
PubMed 32368683
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Diagnostic Value of the Oxygen Reserve Index (ORI) and Spirometry Tests in Predicting Postoperative Respiratory Complications in Patients Undergoing Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT07063277
- Acronym / sponsor ID
- Ankara Bilkent City Hospital 2
- Conditions
- Coronary Arterial Disease (CAD), Coronary Artery Bypass Graft (CABG), Postoperative Pulmonary Complication
- Keywords
- Postoperative Pulmonary Complications, Coronary Artery Bypass Grafting, Oxygen Reserve Index, Spirometry, Cardiac Surgery Risk Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Ankara Bilkent Sehir HastanesiUniversity, hospital or other
- Study start
- 5 Jul 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary artery disease (CAD) is one of the most common cardiac conditions, primarily caused by atherosclerosis. Studies have shown that environmental factors such as lifestyle, diet, genetics, and air pollution contribute to the increasing prevalence of atherosclerosis. Despite advances in non-invasive and medical therapies, coronary artery bypass grafting (CABG) remains a definitive treatment in many cases. CABG is commonly performed using cardiopulmonary bypass (CPB), which increases the risk of additional complications. Among postoperative complications, pulmonary events are the most frequent and are closely associated with increased morbidity and mortality.
Postoperative pulmonary complications (PPCs) significantly raise healthcare costs, prolong hospital stays, and worsen patient outcomes. Cardiac surgery increases susceptibility to PPCs through factors such as sternotomy, CPB, myocardial protection via hypothermia, and phrenic nerve injury. These factors impair thoracic compliance, diaphragm movement, and mucociliary function. Mechanical ventilation further contributes through inflammatory responses that may cause barotrauma and volutrauma.
The incidence of PPCs varies from 1.96% to 43.7%, depending on patient characteristics, surgical type, and diagnostic criteria. With an aging population and more high-risk patients undergoing surgery, the incidence of PPCs is expected to rise. Reported preoperative risk factors include advanced age, active or recent smoking, BMI >25, heart failure, prior myocardial infarction, chronic lung disease, type 2 diabetes mellitus, hypertension, and ASA score >2. Intraoperative factors include prolonged anesthesia, CPB duration >95 minutes, multiple grafts, and use of the internal mammary artery. Postoperative contributors include prolonged ventilation, nasogastric tube use, and insufficient nursing care.
Common PPCs include atelectasis, pneumonia, bronchospasm, pulmonary embolism, pleural effusion, acute respiratory distress syndrome (ARDS), pneumothorax, hemothorax, and transfusion-related acute lung injury (TRALI). Atelectasis is observed in 30-72% of cases on postoperative chest X-rays. TRALI is the leading cause of transfusion-related death and is characterized by hypoxia and bilateral pulmonary infiltrates. Pleural effusions are associated with low BMI, female sex, atrial fibrillation, heart failure, valve surgery, and anticoagulant use. Phrenic nerve injury, often resulting from internal thoracic artery dissection or cold-induced damage during myocardial protection, leads to unilateral diaphragmatic dysfunction.
Hospital-acquired infections, particularly pneumonia, are among the most common and costly non-cardiac complications following cardiac surgery. Pneumonia occurs in 2.4%-20% of cases, while ventilator-associated pneumonia affects 35.2% of patients intubated longer than 48 hours. ARDS is the most severe PPC, involving widespread alveolar injury, endothelial disruption, and non-cardiogenic pulmonary edema. Tension pneumothorax may also occur after chest tube removal.
Spirometry is a standard preoperative test used to assess lung function, primarily through FEV₁ and FVC values. These measurements help detect obstructive or restrictive defects. FEV₁/FVC <70% has been identified as an independent risk factor for PPCs. However, spirometry's predictive value is limited. A systematic review by Dankert et al. reported sensitivities ranging from 38% to 84% and specificities from 55% to 99%. Combined data yielded a sensitivity of 62%, specificity of 70%, and an area under the curve (AUC) of 0.74.
Pulse oximetry alone cannot reliably indicate PaO₂ above 100 mmHg or provide information on oxygen reserve. The Oxygen Reserve Index (ORI) is a novel, continuous, and non-invasive parameter that evaluates oxygenation status in the mild hyperoxic range (PaO₂ 100-200 mmHg). ORI values range from 0.00 to 1.00 and correlate with changes in PaO₂. ORI >0.24 corresponds to PaO₂ ≥100 mmHg when SpO₂ exceeds 98%, while ORI >0.55 may indicate PaO₂ ≥150 mmHg. A declining ORI trend approaching 0.24, despite SpO₂ >98%, can signal impending hypoxemia.
Given the substantial impact of PPCs on postoperative outcomes and the limitations of spirometry in accurately predicting these complications, there is a need for more reliable preoperative assessment tools. The present study aims to compare the diagnostic performance of the Oxygen Reserve Index and spirometry in predicting postoperative respiratory complications in patients undergoing coronary artery bypass surgery. The goal is to identify a more accurate and effective method for preoperative pulmonary risk stratification.
Detailed description
Coronary artery disease (CAD) is one of the most prevalent cardiac disorders caused by atherosclerosis. Comprehensive studies have shown that changes in environmental factors such as lifestyle, diet, genetics, and air pollution contribute to an increased incidence of atherosclerosis. Despite the continuous development of non-invasive and medical treatments, coronary artery bypass grafting (CABG) remains the final treatment option for many patients. In this procedure, open-heart surgery is performed with or without the use of cardiopulmonary bypass (CPB), during which vascular grafts are created. In most cases, CPB is utilized, which may lead to additional complications beyond those associated with the surgery itself. Following CABG, cardiovascular, pulmonary, renal, infectious, and psychiatric complications may occur. Among these, pulmonary complications are the most commonly encountered and are significantly associated with morbidity and mortality.
Postoperative pulmonary complications (PPCs) following cardiac surgery increase healthcare costs, prolong hospital stay, and elevate morbidity and mortality rates. Cardiac surgery predisposes to PPCs more than other surgical types due to median sternotomy/thoracotomy, CPB, myocardial protection via hypothermia, and phrenic nerve injury. It directly impairs thoracic compliance, diaphragm function, and mucociliary clearance. Additionally, mechanical ventilation activates local and systemic inflammatory responses, leading to volutrauma and barotrauma.
The incidence of PPCs following cardiac surgery ranges from 1.96% to 43.7%, depending on patient-related risk factors, the type of cardiac procedure performed, and the definition of PPC used. With the increasing number of high-risk patients undergoing cardiac surgery due to an aging population, a rise in PPC incidence is expected. Preoperative risk factors identified in various studies include age above 65 or 80 years, active smoking within the past 6 or 12 months, body mass index over 25, heart failure, history of myocardial infarction (MI), chronic lung disease, type 2 diabetes mellitus (DM2), hypertension (HT), and an American Society of Anesthesiologists (ASA) score greater than 2. Intraoperative risk factors include anesthesia duration longer than 270 minutes, CPB duration longer than 95 minutes, repair of four or more vessels, and use of the internal mammary artery (IMA) as a graft. Postoperative risk factors include mechanical ventilation for more than 10 hours, presence of a nasogastric tube, and lack of high-quality nursing care.
PPCs include atelectasis, pneumonia, bronchospasm, pulmonary embolism, pleural effusion, acute respiratory distress syndrome (ARDS), pneumothorax, hemothorax, mechanical ventilation longer than 48 hours, transfusion-related acute lung injury (TRALI), and phrenic nerve injury. Atelectasis is a common cause of hypoxemia and impaired gas exchange following cardiac surgery. Postoperative chest X-rays show atelectasis in 30-72% of patients, making it one of the leading causes of respiratory dysfunction. TRALI is the most common transfusion-related adverse event and the leading cause of transfusion-related deaths globally. It is characterized by acute hypoxia and bilateral pulmonary infiltrates following allogeneic blood transfusion. Pleural effusions after CABG are associated with low body mass index, female sex, history of atrial fibrillation, heart failure, concomitant valve surgery, and anticoagulant use. Surgical injury to the phrenic nerve often results in unilateral loss of diaphragmatic function and is commonly observed during dissection of the internal thoracic artery. Previous studies have shown that phrenic nerve injury may also occur due to cold exposure during myocardial protection strategies.
Healthcare-associated infections are a leading cause of non-cardiac morbidity after cardiac surgery. Among these, pneumonia is the most frequently observed, the most expensive, and the most resource-intensive infection. Pneumonia develops in 2.4% to 20% of patients following cardiac surgery. Additionally, ventilator-associated pneumonia occurs in 35.2% of patients who remain on mechanical ventilation for more than 48 hours. ARDS is the most severe pulmonary complication after cardiac surgery, characterized by pro-inflammatory injury to the alveolar structure, widespread endothelial damage, severe hypoxia, and non-cardiogenic pulmonary edema.
Mediastinal and pleural drains are commonly placed after cardiac surgery and are removed when fluid output is minimal and hemodynamic stability is achieved. However, recurrence due to tension pneumothorax following drain removal represents a life-threatening complication. This occurs when a one-way air flow between the lung parenchyma and the pleural space causes air to become trapped in the pleural cavity.
Spirometry is used to assess pulmonary function and is a widely accepted preoperative test in thoracic surgeries. It evaluates the forced expiratory volume in one second (FEV₁) and forced vital capacity (FVC), aiding in the diagnosis of obstructive or restrictive ventilatory defects. Spirometry is closely associated with chronic obstructive pulmonary disease (COPD), asthma, and interstitial lung diseases. An FEV₁/FVC ratio below 70% is considered an independent risk factor for postoperative complications in thoracic surgeries.
Although spirometry is a conventional respiratory function test, its sensitivity and specificity in predicting PPCs remain suboptimal. A systematic review by Dankert et al. reported sensitivities ranging from 38% to 84% and specificities from 55% to 99%. Based on the pooled data from the included studies, a ROC analysis was performed to assess spirometry's predictive value for PPCs. The average sensitivity was found to be 62%, specificity 70%, and area under the curve (AUC) 0.74.
While pulse oximetry is a standard monitoring tool, it does not reliably indicate whether PaO₂ exceeds 100 mmHg or whether oxygen reserves are increasing. Therefore, the Oxygen Reserve Index (ORI) may assist in identifying inadequate preoxygenation and provide preliminary information on pulmonary oxygen reserve. ORI is a non-invasive and continuous parameter that evaluates real-time oxygen reserve within a mild hyperoxic range (approximately PaO₂ 100-200 mmHg). It is measured using a finger sensor and varies between 0.00 and 1.00 depending on oxygen reserve status. Changes in ORI values reflect corresponding changes in PaO₂ within this range. Although ORI and PaO₂ do not show exact correspondence, a positive correlation has been observed within the specified range. Studies have shown that when SpO₂ exceeds 98%, an ORI >0.24 may indicate PaO₂ ≥100 mmHg. Similarly, an ORI >0.55 appears to correspond with PaO₂ ≥150 mmHg. A decline in ORI toward 0.24 while SpO₂ remains >98% may serve as an early indicator of PaO₂ approaching 100 mmHg.
Given the high morbidity and mortality associated with PPCs, especially in cardiac surgery cases, accurate preoperative prediction and appropriate risk stratification are of critical importance. Due to the limited predictive power of spirometry alone, there is a need for novel and updated approaches. The current study aims to evaluate the effectiveness of ORI and spirometry in predicting PPCs. Based on the findings, a more effective method for anticipating pulmonary complications in cardiac surgery may be developed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative Evaluation with ORI and Spirometry | Experimental | Device: Preoperative Evaluation with ORI and SpirometryAll participants in this arm will undergo preoperative evaluation using two non-invasive methods: the Oxygen Reserve Index (ORI) and spirometry. ORI will be measured via a fingertip pulse co-oximetry sensor, reflecting oxygen reserve within the PaO₂ range of 100-200 mmHg. Measurements will be taken during routine preoxygenation with room air and supplemental oxygen. Spirometry will be conducted according to standard pulmonary function testing protocols and will include FEV₁, FVC, and FEV₁/FVC ratio. The aim is to assess and compare the predictive value of ORI and spirometry for identifying postoperative respiratory complications in patients undergoing coronary artery bypass grafting (CABG). No therapeutic intervention will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing elective coronary artery bypass grafting (CABG) surgery.
- Aged 18 years or older at the time of enrollment.
- Provided written informed consent to participate in the study.
- Medically stable and cooperative for preoperative respiratory assessments (ORI and spirometry).
Key exclusion criteria (7 listed)
- Refusal to participate or failure to provide informed consent.
- Age under 18 years.
- Left ventricular ejection fraction below 40% on preoperative evaluation.
- Presence of cognitive impairment or psychiatric disorders preventing cooperation (e.g., dementia, Alzheimer's disease).
- Severe anemia defined as hemoglobin level below 8 g/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative Evaluation with ORI and SpirometryAll participants in this single-arm diagnostic study will undergo preoperative evaluation involving two non-invasive respiratory assessment methods: the Oxygen Reserve Index (ORI) and spirometry. ORI will be measured using a multi-wavelength pulse co-oximetry sensor placed on the patient's fingertip. This sensor provides a continuous, real-time index (ranging from 0.00 to 1.00) that reflects the patient's oxygen reserve within a PaO₂ range of approximately 100-200 mmHg. Spirometry will be performed using standard pulmonary function testing protocols. Each patient will be instructed to perform forced expiratory maneuvers to obtain parameters including forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), and the FEV₁/FVC ratio. These values will be recorded prior to surgery and interpreted according to internationally accepted reference ranges. | Device | Preoperative Evaluation with ORI and Spirometry |
Primary outcome
Incidence of Postoperative Respiratory Complications
Time frame: Postoperative 48 hours
Postoperative respiratory complications, including but not limited to collapse of part or all of a lung (atelectasis), lung infection (pneumonia), the need for continued use of a breathing machine for an extended period after surgery (prolonged mechanical ventilation), or abnormalities in oxygen levels in the blood (oxygenation disorders), will be systematically assessed during the first 48 hours following the surgical procedure. Each event will be evaluated based on clinical symptoms such as shortness of breath, abnormal breath sounds, or decreased oxygen saturation. Additional confirmation will be obtained through diagnostic tools including chest imaging (such as chest X-ray), arterial blood gas analysis, and ventilator parameters. The presence, timing, and severity of each complication will be documented, as well as any medical or mechanical respiratory support required (such as supplemental oxygen, non-invasive ventilation, or reintubation)
8 secondary outcomes
Preoperative Peak ORI Value
Time frame: Preoperative period (within 24 hours prior to surgery)
FEV₁ (Forced Expiratory Volume in 1 second)
Time frame: Preoperative period (within 24 hours prior to surgery)
Intraoperative Respiratory Complications
Time frame: During surgery
Intraoperative Hemodynamic or Surgical Complications
Time frame: During surgery
Duration of Intensive Care Unit and Total Hospital Stay
Time frame: From the date of surgery until ICU and hospital discharge, assessed up to 180 days
In-Hospital Postoperative Mortality
Time frame: From the date of surgery until hospital discharge, assessed up to 180 days
FVC (Forced Vital Capacity)
Time frame: Preoperative period (within 24 hours prior to surgery)
PEF (Peak Expiratory Flow)
Time frame: Preoperative period (within 24 hours prior to surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Results publication: PubMed 28791567Scheeren TWL, Belda FJ, Perel A. The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):379-389. doi: 10.1007/s10877-017-0049-4. Epub 2017 Aug 8.
- Results publication: PubMed 31904726Chen ST, Min S. Oxygen reserve index, a new method of monitoring oxygenation status: what do we need to know? Chin Med J (Engl). 2020 Jan 20;133(2):229-234. doi: 10.1097/CM9.0000000000000625.
- Results publication: PubMed 34939921Dankert A, Dohrmann T, Loser B, Zapf A, Zollner C, Petzoldt M. Pulmonary Function Tests for the Prediction of Postoperative Pulmonary Complications. Dtsch Arztebl Int. 2022 Feb 18;119(7):99-106. doi: 10.3238/arztebl.m2022.0074.
- Results publication: PubMed 26935262Yoshimi K, Oh S, Suzuki K, Kodama Y, Sekiya M, Seyama K, Fukuchi Y. Impact of Airflow Limitation on Comorbidities and Postoperative Complications in Patients Undergoing Thoracic Surgery: A Retrospective Observational Study. Ann Thorac Cardiovasc Surg. 2016 Jun 20;22(3):146-52. doi: 10.5761/atcs.oa.15-00301. Epub 2016 Mar 1.
- Results publication: PubMed 32944327Park HJ, Kim SM, Kim HR, Ji W, Choi CM. The value of preoperative spirometry testing for predicting postoperative risk in upper abdominal and thoracic surgery assessed using big-data analysis. J Thorac Dis. 2020 Aug;12(8):4157-4167. doi: 10.21037/jtd-19-2687.
- Results publication: PubMed 33175990Tanner TG, Colvin MO. Pulmonary Complications of Cardiac Surgery. Lung. 2020 Dec;198(6):889-896. doi: 10.1007/s00408-020-00405-7. Epub 2020 Nov 11.
- Results publication: PubMed 17347049Jensen L, Yang L. Risk factors for postoperative pulmonary complications in coronary artery bypass graft surgery patients. Eur J Cardiovasc Nurs. 2007 Sep;6(3):241-6. doi: 10.1016/J.EJCNURSE.2006.11.001. Epub 2007 Mar 7.
- Results publication: PubMed 31876045Thanavaro J, Taylor J, Vitt L, Guignon MS, Thanavaro S. Predictors and outcomes of postoperative respiratory failure after cardiac surgery. J Eval Clin Pract. 2020 Oct;26(5):1490-1497. doi: 10.1111/jep.13334. Epub 2019 Dec 25.
- Results publication: PubMed 32368683Mali S, Haghaninejad H. Pulmonary complications following cardiac surgery. Arch Med Sci Atheroscler Dis. 2019 Dec 31;4:e280-e285. doi: 10.5114/amsad.2019.91432. eCollection 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Evaluation with ORI and Spirometry in people with Coronary Arterial Disease (CAD) and Coronary Artery Bypass Graft (CABG), run by Ankara Bilkent Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Respiratory Complications (time frame: Postoperative 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07063277, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.