One-Lung VentilationNCT04260451
Driving Pressure and Postoperative Pulmonary Complications in Thoracic Surgery
A study testing ventilation in people with One-Lung Ventilation and Postoperative Complications, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Pulmonary complications are the most common complication in thoracic surgery and the leading cause of mortality.Therefore, lung protection is utmost important, and protective ventilation is strongly recommended in thoracic surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- One-Lung Ventilation, Postoperative Complications, Driving Pressure
- What is being tested?
- ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2020to 31 May 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults older than or equal to 19 years with American Society of Anesthesiologists physical status Ⅰ-Ⅲ Patient who undergoes one-lung ventilation (more than 60 minutes) for elective thoracic surgery
Who cannot join
- The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
- Symptoms of heart failure (hypertension, urination, pulmonary edema, left ventricular outflow rate <45%) or preoperative vasopressors
- Patient who is received oxygen therapy and ventilation care
- large emphysema and pneumothorax
- pregnancy and lactation
- patients participating in similar studies
Show all 12Show fewer
- Joint with other operation
- Patient who rejects being enrolled in the study
- Patients with elevated intracranial pressure
- Patients with peripheral neuropathy or blood circulation disorders
- Patients with hematology disease
- Congenital heart disease with shunt
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Pulmonary Complications Between Driving Pressure Guided Ventilation and Conventional Protective Ventilation in Thoracic Surgery
Pulmonary complications are the most common complication in thoracic surgery and the leading cause of mortality.Therefore, lung protection is utmost important, and protective ventilation is strongly recommended in thoracic surgery. Protective ventilation is a prevailing ventilatory strategy in these days and is comprised of small tidal volume, limited inspiratory pressure, and application of positive end-expiratory pressure. However, several retrospective studies recently suggested that tidal volume, inspiratory pressure, and positive end-expiratory pressure are not related to patient outcomes, or only related when they influenced the driving pressure. Recently, the investigators reported the first prospective study about the driving pressure-guided ventilation in thoracic surgery. PEEP was titrated to bring the lowest driving pressure in each patient and applied throughout the one lung ventilation. The application of individualized PEEP reduced the incidence of pulmonary complications.However, that study was small size single center study with 312 patients. Thus, investigators try to perform large scale multicenter study. Through this study investigators evaluate that driving pressure-guided ventilation can reduce the incidence of postoperative pulmonary complications compared with conventional protective ventilation in thoracic surgery.
Read the detailed description
Nowdays, the usual setting of protective ventilation during one lung ventilation is tidal volume (VT) 5 ml/kg of predicted body weight, positive end-expiratory pressure (PEEP) 5 cm H2O and plateau pressure (Pplat) less than 25 cmH2O.
However, a high incidence of postoperative pulmonary complications is still being observed even with a protective ventilatory strategy.
Driving pressure is [Pplat - PEEP] and is the pressure required for the alveolar opening. Static lung compliance (Cstat) is expressed as [VT / (Pplat - PEEP)]. Thus, driving pressure is also expressed as [VT / Cstat]. Driving pressure has an inverse relationship with Cstat and orthodromic relationship with VT according to this formula. High driving pressure indicates poor lung condition with decreased lung compliance.
Thus, investigator try to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation in large scale multicenter study.
Recruit maneuver perform all group after intubation (stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg).
The control arm receives existing conventional protective ventilation with tidal volume of 5mL/kg of ideal body weight and PEEP of 5 cmH2O during one-lung ventilation.
The driving pressure arm receives driving pressure limited ventilation with tidal volume of 5mL/kg of ideal body weight and individualized PEEP. Individualized PEEP is adjusted to minimize driving pressure, it find through decremental PEEP titration from 10 to 2 cmH2O during one-lung ventilation.
- Conditions
- One-Lung Ventilation, Postoperative Complications, Driving Pressure, Postoperative Pulmonary Complication, Thoracic Surgery, Positive End Expiratory Pressure
- Being tested
- ventilation
- Keywords
- Postoperative pulmonary complication, Driving pressure, Thoracic surgery, One lung ventilation, Positive end expiratory pressure
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilationOther
Driving Pressure Limited Ventilation
Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 10 to 2 cmH2O during one-lung ventilation.
- Lung recruitment: stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg, inspiratory:expiratory 1:1, respiratory rate 10. and driving pressure up to 20 cmH2O. Then decremental PEEP titration is performed using a volume-controlled ventilation until the lowest driving pressure (plateau pressure minus PEEP) is found. This individualized PEEP is adjusted during one-lung ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Driving pressure group | Experimental | Positive end expiratory pressure is adjusted to tidal volume of 5 mL/kg of ideal body weight, inspiratory:expiratory=1:2, and minimize driving pressure (plateau pressure minus end expiratory pressure) during one-lung ventilation. Other procedures are same with the control arm. Receives: Other: ventilation |
| Protective Ventilation | No intervention | The control arm receives existing conventional protective ventilation with tidal volume of 5mL/kg of ideal body weight and positive end expiratory pressure of 5cmH2O during one-lung ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of postoperative pulmonary complications
Postoperative pulmonary complications are defined as one or more of the following:
- Hypoxia: SpO2 < 90%
- Requiring oxygen therapy: Facial mask, nasal prong, continuous positive airway pressure, non-invasive positive pressure breathing or high flow nasal oxygen supply between POD 2 and 7.
- Initial ventilator supports longer than 24 h
- Re-intubation
- Requiring mechanical ventilation
- Tracheostomy
- Pneumonia
- Empyema
- Atelectasis requiring bronchoscopy
- Acute respiratory distress syndrome
- Acute lung injury
- Persistent emphysema or pneumothorax or air leak requiring chest tube for 5 days or more
- Prolonged pleural effusion requiring chest tube for 5 days or more
- Bronchopleural fistula
- Contralateral pneumothorax
- Pulmonary embolism embolism
Measured: within the first 7 days after surgery
Secondary outcomes (16)
oxygenation
Partial pressure of oxygen in arterial blood (PaO2, mmHg) or PaO2/Inspired oxygen fraction (PF ratio)
Measured: 15 minutes after one-lung ventilation
the incidence of rescue ventilation
the need for rescue ventilation to treat hypoxia (Inspired oxygen fraction 1.0, two lung ventilation, recruitment, PEEP change, Tidal volume change, continuous positive pressure ventilation, change to pressure control mode)
Measured: during surgery
Cstat
Lung compliance (mL/mmHg)
Measured: 15 minutes after one-lung ventilation
CRP
C-reactive protein (mg/L) of laboratory exam
Measured: within the first 1 days after surgery
the incidence of postoperative transfusion
red blood cell, fresh frozen plasma, platelet
Measured: within the first 3 days after surgery
the incidence of postoperative renal complications
acute kidney injury(acute kidney injury network criteria): Stage I: Diuresis < 0.5 mg/kg (6 h) or increase in serum Cr > 0.3 mg/dl. Stage II: Diuresis < 0.5 mg/kg (12 h) or basal Cr x 2 mg/dL. Stage III: Diuresis < 0.3 mg/kg (24 h) or anuria (12 h) or basal Cr x 3 mg/dL, or Cr > 4 mg/dL or renal replacement therapy.
Measured: within the first 7 days after surgery
the incidence of postoperative cognitive complications
diagnosed by Confusion Assessment method (CAM: positive or negative) or Medicines for treating delirium symptoms include antipsychotic drugs and benzodiazepines
Measured: within the first 7 days after surgery
the incidence of postoperative surgical site complications
: The CDC defines a superficial incisional surgical site infection as one which meets the following criteria.
- Infection occurs within 30 days after surgery and
- Involves only skin and subcutaneous tissue of the incision and
- The patient has at least one of the following:
- purulent drainage from the superficial incision
- organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
- at least one of the following symptoms or signs of infection: pain or tenderness, localised swelling, redness or heat, and superficial incision is deliberately opened by surgeon and is culture positive or not cultured. A culture negative finding does not meet this criterion.
- diagnosis of an incisional surgical site infection by a surgeon or attending physician.
Measured: within the first 7 days after surgery
the incidence of acute myocardial infarction
Acute myocardial injury with clinical evidence of acute myocardial ischemia and with detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit and at least one of the following:
- Symptoms of myocardial ischemia
- New ischemic ECG changes
- Development of pathological Q waves
- Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
- Identification of a coronary thrombus by angiography or autopsy (not for types 2 or 3 myocardial infarctions)
Measured: within the first 7 days after surgery
the incidence of coronary thrombosis
Percutaneous coronary intervention or coronary artery surgery
Measured: within the first 7 days after surgery
the incidence of cerebral infarction
Magnetic resonance imaging diagnosis
Measured: within the first 7 days after surgery
the incidence of septic shock
: A subset of sepsis (a life-threatening organ dysfunction resulting from dysregulated host responses to infection) in which underlying circulatory, cellular, and metabolic abnormalities are profound enough to substantially increase the risk of mortality. Despite adequate fluid resuscitation, patients have hypotension requiring vasopressors to maintain a mean arterial blood pressure above 65 mmHg and have an elevated serum lactate concentration of more than 2 mmol/L
Measured: within the first 7 days after surgery
the incidence of new arrythmia
New arrhythmias that persist for more than 2 days
Measured: within the first 7 days after surgery
Length of stay in the intensive care unit and hospital
the duration of hospital stay and intensive care unit stay (day)
Measured: within the first 30 days after surgery
the incidence of re-admission
re-admission because of surgical related problems
Measured: within the first 30 days after surgery
mortality
in hospital death or out of hospital
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start2 Mar 2020
- Primary completion15 Apr 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Seoul National University Hospital, Asan Medical Center, Korea University Guro Hospital, The Catholic University of Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260451
- Sponsor's protocol ID
- SMC2019-07-182-009
- Status last verified
- Jul 2021
- First submitted
- 31 Jan 2020
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park M, Yoon S, Nam JS, Ahn HJ, Kim H, Kim HJ, Choi H, Kim HK, Blank RS, Yun SC, Lee DK, Yang M, Kim JA, Song I, Kim BR, Bahk JH, Kim J, Lee S, Choi IC, Oh YJ, Hwang W, Lim BG, Heo BY. Driving pressure-guided ventilation and postoperative pulmonary complications in thoracic surgery: a multicentre randomised clinical trial. Br J Anaesth. 2023 Jan;130(1):e106-e118. doi: 10.1016/j.bja.2022.06.037. Epub 2022 Aug 20.
PubMed 35995638
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pulmonary Complications Between Driving Pressure Guided Ventilation and Conventional Protective Ventilation in Thoracic Surgery
- ClinicalTrials.gov ID
- NCT04260451
- Acronym / sponsor ID
- SMC2019-07-182-009
- Conditions
- One-Lung Ventilation, Postoperative Complications, Driving Pressure, Postoperative Pulmonary Complication, Thoracic Surgery, Positive End Expiratory Pressure
- Keywords
- Postoperative pulmonary complication, Driving pressure, Thoracic surgery, One lung ventilation, Positive end expiratory pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Severance Hospital, Seoul National University Hospital, Asan Medical Center, Korea University Guro Hospital, The Catholic University of Korea
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 7 Feb 2020 (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.
Pulmonary complications are the most common complication in thoracic surgery and the leading cause of mortality.Therefore, lung protection is utmost important, and protective ventilation is strongly recommended in thoracic surgery. Protective ventilation is a prevailing ventilatory strategy in these days and is comprised of small tidal volume, limited inspiratory pressure, and application of positive end-expiratory pressure. However, several retrospective studies recently suggested that tidal volume, inspiratory pressure, and positive end-expiratory pressure are not related to patient outcomes, or only related when they influenced the driving pressure. Recently, the investigators reported the first prospective study about the driving pressure-guided ventilation in thoracic surgery. PEEP was titrated to bring the lowest driving pressure in each patient and applied throughout the one lung ventilation. The application of individualized PEEP reduced the incidence of pulmonary complications.However, that study was small size single center study with 312 patients. Thus, investigators try to perform large scale multicenter study. Through this study investigators evaluate that driving pressure-guided ventilation can reduce the incidence of postoperative pulmonary complications compared with conventional protective ventilation in thoracic surgery.
Detailed description
Nowdays, the usual setting of protective ventilation during one lung ventilation is tidal volume (VT) 5 ml/kg of predicted body weight, positive end-expiratory pressure (PEEP) 5 cm H2O and plateau pressure (Pplat) less than 25 cmH2O.
However, a high incidence of postoperative pulmonary complications is still being observed even with a protective ventilatory strategy.
Driving pressure is [Pplat - PEEP] and is the pressure required for the alveolar opening. Static lung compliance (Cstat) is expressed as [VT / (Pplat - PEEP)]. Thus, driving pressure is also expressed as [VT / Cstat]. Driving pressure has an inverse relationship with Cstat and orthodromic relationship with VT according to this formula. High driving pressure indicates poor lung condition with decreased lung compliance.
Thus, investigator try to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation in large scale multicenter study.
Recruit maneuver perform all group after intubation (stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg).
The control arm receives existing conventional protective ventilation with tidal volume of 5mL/kg of ideal body weight and PEEP of 5 cmH2O during one-lung ventilation.
The driving pressure arm receives driving pressure limited ventilation with tidal volume of 5mL/kg of ideal body weight and individualized PEEP. Individualized PEEP is adjusted to minimize driving pressure, it find through decremental PEEP titration from 10 to 2 cmH2O during one-lung ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driving pressure group | Experimental | Other: ventilationPositive end expiratory pressure is adjusted to tidal volume of 5 mL/kg of ideal body weight, inspiratory:expiratory=1:2, and minimize driving pressure (plateau pressure minus end expiratory pressure) during one-lung ventilation. Other procedures are same with the control arm. |
| Protective Ventilation | No intervention | –The control arm receives existing conventional protective ventilation with tidal volume of 5mL/kg of ideal body weight and positive end expiratory pressure of 5cmH2O during one-lung ventilation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults older than or equal to 19 years with American Society of Anesthesiologists physical status Ⅰ-Ⅲ Patient who undergoes one-lung ventilation (more than 60 minutes) for elective thoracic surgery
Key exclusion criteria (12 listed)
- The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
- Symptoms of heart failure (hypertension, urination, pulmonary edema, left ventricular outflow rate <45%) or preoperative vasopressors
- Patient who is received oxygen therapy and ventilation care
- large emphysema and pneumothorax
- pregnancy and lactation
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 |
|---|---|---|
| ventilationDriving Pressure Limited Ventilation Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 10 to 2 cmH2O during one-lung ventilation. 1. Lung recruitment: stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg, inspiratory:expiratory 1:1, respiratory rate 10. and driving pressure up to 20 cmH2O. Then decremental PEEP titration is performed using a volume-controlled ventilation until the lowest driving pressure (plateau pressure minus PEEP) is found. This individualized PEEP is adjusted during one-lung ventilation. | Other | Driving pressure group |
Primary outcome
the incidence of postoperative pulmonary complications
Time frame: within the first 7 days after surgery
Postoperative pulmonary complications are defined as one or more of the following: * Hypoxia: SpO2 < 90% * Requiring oxygen therapy: Facial mask, nasal prong, continuous positive airway pressure, non-invasive positive pressure breathing or high flow nasal oxygen supply between POD 2 and 7. * Initial ventilator supports longer than 24 h * Re-intubation * Requiring mechanical ventilation * Tracheostomy * Pneumonia * Empyema * Atelectasis requiring bronchoscopy * Acute respiratory distress syndrome * Acute lung injury * Persistent emphysema or pneumothorax or air leak requiring chest tube for 5 days or more * Prolonged pleural effusion requiring chest tube for 5 days or more * Bronchopleural fistula * Contralateral pneumothorax * Pulmonary embolism embolism
16 secondary outcomes
oxygenation
Time frame: 15 minutes after one-lung ventilation
the incidence of rescue ventilation
Time frame: during surgery
Cstat
Time frame: 15 minutes after one-lung ventilation
CRP
Time frame: within the first 1 days after surgery
the incidence of postoperative transfusion
Time frame: within the first 3 days after surgery
the incidence of postoperative renal complications
Time frame: within the first 7 days after surgery
the incidence of postoperative cognitive complications
Time frame: within the first 7 days after surgery
the incidence of postoperative surgical site complications
Time frame: within the first 7 days after surgery
the incidence of acute myocardial infarction
Time frame: within the first 7 days after surgery
the incidence of coronary thrombosis
Time frame: within the first 7 days after surgery
the incidence of cerebral infarction
Time frame: within the first 7 days after surgery
the incidence of septic shock
Time frame: within the first 7 days after surgery
the incidence of new arrythmia
Time frame: within the first 7 days after surgery
Length of stay in the intensive care unit and hospital
Time frame: within the first 30 days after surgery
the incidence of re-admission
Time frame: within the first 30 days after surgery
mortality
Time frame: within the first 30 days after 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 12 Jul 2021.
- Derived from this study: PubMed 35995638Park M, Yoon S, Nam JS, Ahn HJ, Kim H, Kim HJ, Choi H, Kim HK, Blank RS, Yun SC, Lee DK, Yang M, Kim JA, Song I, Kim BR, Bahk JH, Kim J, Lee S, Choi IC, Oh YJ, Hwang W, Lim BG, Heo BY. Driving pressure-guided ventilation and postoperative pulmonary complications in thoracic surgery: a multicentre randomised clinical trial. Br J Anaesth. 2023 Jan;130(1):e106-e118. doi: 10.1016/j.bja.2022.06.037. Epub 2022 Aug 20.
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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 ventilation in people with One-Lung Ventilation and Postoperative Complications, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 12 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 12 Jul 2021. 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 South Korea. 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?
the incidence of postoperative pulmonary complications (time frame: within the first 7 days after surgery). 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 NCT04260451, which also lists 1 linked publication.
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 12 Jul 2021.