One-lung VentilationNCT06376123
Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation
An observational study of One-lung Ventilation, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- One-lung Ventilation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Nov 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes patients with pulmonary diseases, indicated for surgery. Among them are pulmonectomy, segmentectomy, lobectomy or wedge resections. All these types of surgery require one-lung (non-operating lung) ventilation. The patients should be electively operated, aged more that 18 years and must have no other pulmonary conditions (like fibrosis, pneumonia, lung oedema or interstitial lung disease) that could interfere with Alveolo-arterial gradient calculations.
Who may be able to join
- Patients scheduled for elective VATS surgery.
- Age over 18 years.
- ASA 1-4 patients.
Who cannot join
- Patient refusal.
- Age below 18 years.
- Conditions that may impair oxygen diffusion: pulmonary oedema, fibrosis, interstitial lung disease, pneumonia.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Dragos Hospital
Istanbul, Maltepe, 34844
About this study
The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. The importance of our study is to collect some of the patient's parameters on a nomogram in the preoperative period, to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly.
Read the detailed description
The shunt that occurs during one lung ventilation varies for each patient and depends on many parameters. In this study, our aim was to predict the level of shunting during anaesthesia using readily available preoperative data. It is important to predict the hypoxia that will develop due to the shunt and to plan the methods that can be applied to reduce the shunt in terms of patient safety. One of the most reliable data reflecting the shunt level is the gradient of alvelo- arterial oxygen concentration. The calculation of alveolo-arterial oxygen gradient (A-a O2 gradient) is based on easily accessible parameters (pO2, pCO2, FiO2, age). The secondary aim of the study is to follow how the A-a O2 gradient (oxygen difference between alveolar and arterial blood) changes over time during surgery.
Demographic data, planned operation, comorbidities, side of surgery, ASA score, preoperative haemoglobin level, FEV1 (forced expiratory volume in 1 minute), FEV1/FVC (forced expiratory volume in 1 minute/forced vital capacity) ratio and EF (ejection fraction) will be recorded before surgery.FEV1, FEV1/FVC ratio values will be measured by spirometry test. Spirometry is a preoperative test routinely performed in all patients undergoing one lung ventilation. EF will be measured by preoperative echocadiography, which is also performed during the preoperative preparation of all patients scheduled for lung surgery. Patients undergoing VATS (video-assisted thoracoscopy) surgery with planned lung resection, lobectomy, pulmonectomy, segmentectomy etc. will be included in the study and all will be operated in the lateral decubitus position.
Once the patient is on the operating table, routine haemodynamic monitoring (heart rate, non-invasive blood pressure and blood oxygen saturation) will be performed.
The patient will then have an arterial cannula inserted for invasive arterial monitoring. It is a routine practice in major surgeries for blood gas monitoring, haemorrhage monitoring and monitoring of sudden blood pressure fluctuations. After insertion of the arterial cannula, blood gas will be taken in room air and arterial pO2 (partial oxygen pressure), arterial pCO2 (partial carbon dioxide pressure) and arterial SpO2 (oxygen saturation) will be recorded. At the same time, a venous blood sample (from any vein in the upper limb) will be taken in room air and vSpO2 (venous blood oxygen saturation) will be recorded. The difference between SpO2 of arterial and venous blood is determined as Delta-SpO2 and is a specific parameter of this study.
All patients will undergo general anaesthesia and orotracheal intubation with a double lumen tube.
For anaesthesia induction, 1 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be administered .After adequate mask ventilation and complete muscle relaxation, a double lumen intubation tube will be placed into the trachea by direct laryngoscopy. After the position of the tube and whether it is in the correct bronchus is supported by bronchoscopy, the patient will be connected to the mechanical ventilator and lateral decubitus (provided that the side to be operated on remains on top) will be given. Ventilator parameters will be selected the same for all patients. During two-lung ventilation, tidal volume 8 ml/kg, respiratory rate 12, peep 5, and FiO2 (fraction of inspired oxygen) = 60%. During one-lung ventilation, tidal volume will be set to 6 ml/min, respiratory rate 15, peep 5, and FiO2 = 70%. All patients will be ventilated in volume control mode.
At this stage, EtCO2 (end-tidal carbon dioxide) will be measured separately in both lungs. For this, first the airway from the lower lung will be clamped and the EtCO2 value will be recorded (dEtCO2 - dependent lung EtCO2). Then, vice versa, the airway from the lower lung will be clamped and the EtCO2 value obtained (ndEtCO2 - non-dependent lung EtCO2) will be recorded. The difference between these two values, D-EtCO2 (delta - end-tidal carbon dioxide) will be added to the data.
After these steps, one-lung ventilation will be started and the first A-a oxygen gradient will be recorded 30 minutes after initiation of OLV. The consequent calculations of OLV will be made every 30 minutes until the end of the surgery. The consequent measurements are necessary for estimation the A-a gradient change over time.
- Conditions
- One-lung Ventilation
- Keywords
- One lung ventilation, Alveolo-arterial gradient, Nomograms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Video assisted thoracoscopic surgery patients | Patients, assigned for elective lung surgery, older than 18 years and requiring one-lung ventilation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolo-arterial gradient
The gradient of oxygen concentration between alveoli and arterial blood, achieved after patient switch from double lung to one lung lung ventilation. Is calculated automatically, based on oxygen tension in arterial and venous blood, which measured by blood gas analysis.
Measured: 30 mins after intubation
Secondary outcomes (1)
Alveolo-arterial gradient change
The gradient of oxygen concentration between alveoli and arterial blood, achieved after patient switch from double lung to one lung lung ventilation. It is measured be blod gas analysis. The secondary outcome involves the changes of the first outcome throughout the surgery and is measured every 30 minutes
Measured: After switching to one lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for One-lung VentilationStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Responsible party
- Principal investigator, Nıgar Kangarlı, Bezmialem Vakif University
- Investigators
- Nigar Kangarli, MD, Principal investigator, Anesthesiology and Reanimation Department, Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376123
- Sponsor's protocol ID
- Nkangarli001
- Status last verified
- Dec 2025
- First submitted
- 17 Apr 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parab SY, Chatterjee A, Saxena RS. The utility of gradient of end-tidal carbon dioxide between two lungs in lateral decubitus position in predicting a drop in oxygenation during one-lung ventilation in elective thoracic surgery- A prospective observational study. Indian J Anaesth. 2021 Oct;65(10):744-749. doi: 10.4103/ija.ija_591_21. Epub 2021 Oct 29.
PubMed 34898701Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.
PubMed 19417615Alday E, Nieves JM, Planas A. Oxygen Reserve Index Predicts Hypoxemia During One-Lung Ventilation: An Observational Diagnostic Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):417-422. doi: 10.1053/j.jvca.2019.06.035. Epub 2019 Jun 28.
PubMed 31362907
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nomogram for Prediction of Alveolo-arterial Gradient During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT06376123
- Acronym / sponsor ID
- Nkangarli001
- Conditions
- One-lung Ventilation
- Keywords
- One lung ventilation, Alveolo-arterial gradient, Nomograms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 19 Apr 2024 (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.
The cause of hypoxia during one-lung ventilation is a common anaesthetic problem seen during thoracic surgery and is associated with increased fraction of shunted blood. This shunt occurs because the lung not participating in respiration stops saturating the blood with oxygen. The importance of our study is to collect some of the patient's parameters on a nomogram in the preoperative period, to predict the shunt fraction that will occur during one-lung ventilation and to make preparations and interventions accordingly.
Detailed description
The shunt that occurs during one lung ventilation varies for each patient and depends on many parameters. In this study, our aim was to predict the level of shunting during anaesthesia using readily available preoperative data. It is important to predict the hypoxia that will develop due to the shunt and to plan the methods that can be applied to reduce the shunt in terms of patient safety. One of the most reliable data reflecting the shunt level is the gradient of alvelo- arterial oxygen concentration. The calculation of alveolo-arterial oxygen gradient (A-a O2 gradient) is based on easily accessible parameters (pO2, pCO2, FiO2, age). The secondary aim of the study is to follow how the A-a O2 gradient (oxygen difference between alveolar and arterial blood) changes over time during surgery.
Demographic data, planned operation, comorbidities, side of surgery, ASA score, preoperative haemoglobin level, FEV1 (forced expiratory volume in 1 minute), FEV1/FVC (forced expiratory volume in 1 minute/forced vital capacity) ratio and EF (ejection fraction) will be recorded before surgery.FEV1, FEV1/FVC ratio values will be measured by spirometry test. Spirometry is a preoperative test routinely performed in all patients undergoing one lung ventilation. EF will be measured by preoperative echocadiography, which is also performed during the preoperative preparation of all patients scheduled for lung surgery. Patients undergoing VATS (video-assisted thoracoscopy) surgery with planned lung resection, lobectomy, pulmonectomy, segmentectomy etc. will be included in the study and all will be operated in the lateral decubitus position.
Once the patient is on the operating table, routine haemodynamic monitoring (heart rate, non-invasive blood pressure and blood oxygen saturation) will be performed.
The patient will then have an arterial cannula inserted for invasive arterial monitoring. It is a routine practice in major surgeries for blood gas monitoring, haemorrhage monitoring and monitoring of sudden blood pressure fluctuations. After insertion of the arterial cannula, blood gas will be taken in room air and arterial pO2 (partial oxygen pressure), arterial pCO2 (partial carbon dioxide pressure) and arterial SpO2 (oxygen saturation) will be recorded. At the same time, a venous blood sample (from any vein in the upper limb) will be taken in room air and vSpO2 (venous blood oxygen saturation) will be recorded. The difference between SpO2 of arterial and venous blood is determined as Delta-SpO2 and is a specific parameter of this study.
All patients will undergo general anaesthesia and orotracheal intubation with a double lumen tube.
For anaesthesia induction, 1 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be administered .After adequate mask ventilation and complete muscle relaxation, a double lumen intubation tube will be placed into the trachea by direct laryngoscopy. After the position of the tube and whether it is in the correct bronchus is supported by bronchoscopy, the patient will be connected to the mechanical ventilator and lateral decubitus (provided that the side to be operated on remains on top) will be given. Ventilator parameters will be selected the same for all patients. During two-lung ventilation, tidal volume 8 ml/kg, respiratory rate 12, peep 5, and FiO2 (fraction of inspired oxygen) = 60%. During one-lung ventilation, tidal volume will be set to 6 ml/min, respiratory rate 15, peep 5, and FiO2 = 70%. All patients will be ventilated in volume control mode.
At this stage, EtCO2 (end-tidal carbon dioxide) will be measured separately in both lungs. For this, first the airway from the lower lung will be clamped and the EtCO2 value will be recorded (dEtCO2 - dependent lung EtCO2). Then, vice versa, the airway from the lower lung will be clamped and the EtCO2 value obtained (ndEtCO2 - non-dependent lung EtCO2) will be recorded. The difference between these two values, D-EtCO2 (delta - end-tidal carbon dioxide) will be added to the data.
After these steps, one-lung ventilation will be started and the first A-a oxygen gradient will be recorded 30 minutes after initiation of OLV. The consequent calculations of OLV will be made every 30 minutes until the end of the surgery. The consequent measurements are necessary for estimation the A-a gradient change over time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video assisted thoracoscopic surgery patients | – | –Patients, assigned for elective lung surgery, older than 18 years and requiring one-lung ventilation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes patients with pulmonary diseases, indicated for surgery. Among them are pulmonectomy, segmentectomy, lobectomy or wedge resections. All these types of surgery require one-lung (non-operating lung) ventilation. The patients should be electively operated, aged more that 18 years and must have no other pulmonary conditions (like fibrosis, pneumonia, lung oedema or interstitial lung disease) that could interfere with Alveolo-arterial gradient calculations.
Key inclusion criteria (3 listed)
- Patients scheduled for elective VATS surgery.
- Age over 18 years.
- ASA 1-4 patients.
Key exclusion criteria (4 listed)
- Patient refusal.
- Age below 18 years.
- Conditions that may impair oxygen diffusion: pulmonary oedema, fibrosis, interstitial lung disease, pneumonia.
- Emergency surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alveolo-arterial gradient
Time frame: 30 mins after intubation
The gradient of oxygen concentration between alveoli and arterial blood, achieved after patient switch from double lung to one lung lung ventilation. Is calculated automatically, based on oxygen tension in arterial and venous blood, which measured by blood gas analysis.
1 secondary outcome
Alveolo-arterial gradient change
Time frame: After switching to one lung ventilation
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 24 Dec 2025.
- Background: PubMed 34898701Parab SY, Chatterjee A, Saxena RS. The utility of gradient of end-tidal carbon dioxide between two lungs in lateral decubitus position in predicting a drop in oxygenation during one-lung ventilation in elective thoracic surgery- A prospective observational study. Indian J Anaesth. 2021 Oct;65(10):744-749. doi: 10.4103/ija.ija_591_21. Epub 2021 Oct 29.
- Background: PubMed 19417615Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.
- Background: PubMed 31362907Alday E, Nieves JM, Planas A. Oxygen Reserve Index Predicts Hypoxemia During One-Lung Ventilation: An Observational Diagnostic Study. J Cardiothorac Vasc Anesth. 2020 Feb;34(2):417-422. doi: 10.1053/j.jvca.2019.06.035. Epub 2019 Jun 28.
- 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.
Nigar Kangarli, MD principal investigator
Anesthesiology and Reanimation Department, Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of One-lung Ventilation, run by Bezmialem Vakif University 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 3 inclusion and 4 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 24 Dec 2025. 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?
Alveolo-arterial gradient (time frame: 30 mins after intubation). 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 NCT06376123, which also lists 3 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 24 Dec 2025.