Ventilator-Induced Lung InjuryNCT04519606
Respiratory Mechanics During One-lung Ventilation
An observational study of Ventilator-Induced Lung Injury and Lung Ventilator, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
Intraoperative lung protective ventilatory strategy has been widely recognized to reduce postoperative pulmonary complications in laparotomy and laparoscopic surgeries. However, the clinical evidence and consensus for ventilatory strategy to protect the dependent lung segments during thoracic surgery that requires… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Ventilator-Induced Lung Injury, Lung Ventilator, One-lung Ventilation
- What is being tested?
- Optimal lung compliance during OLV
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2020to 30 Sep 2021
- How long will I take part?
- 3 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Generally healthy (ASA PC I-III) patients receiving thoracic surgery that required intraoperative OLV
Who may be able to join
- Scheduled for single lobectomy or wedge resection of right or left lung lobe
- American Society of Anesthesiologists physical classification (ASA PC) I-III
- Preoperative normal pulmonary function test
Who cannot join
- Anticipated difficult intubation or ventilation
- Severe heart failure (NYHA Fc >=3)
- Advanced liver cirrhosis (Child-Pugh score >=B)
- Advanced renal disease (creatinine >2 mg/dl)
- Severe anemia (hemoglobin <8 mg/dl)
- Body mass index >30
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- Pregnancy
- Emergency operation
- Prior history of heart, lung or mediastinal surgery
- Psychiatric or other mental disorders
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Respiratory Mechanics During One-lung Ventilation
Intraoperative lung protective ventilatory strategy has been widely recognized to reduce postoperative pulmonary complications in laparotomy and laparoscopic surgeries. However, the clinical evidence and consensus for ventilatory strategy to protect the dependent lung segments during thoracic surgery that requires one-lung ventilation (OLV) is currently not available. Since lung compliance changes significantly during OLV, the levels of respiratory mechanics should be optimized to avoid barotrauma and volutrauma. This study aims to determine the optimal levels of volume-pressure dynamics during OLV and at the phase of recruitment of the independent lungs by achieving optimal lung compliance, gas exchange and hemodynamics.
Read the detailed description
Background One-lung ventilation (OLV) is the foremost used technique of ventilation during thoracic procedures. Intraoperative lung separation can be managed by means of double-lumen endotracheal tube (DLT), bronchial blocker (BB), or nonintubated method. OLV is impeded by significant reduction in lung volume, decline in lung compliance at lateral decubital position, formation of intrapulmonary shunting and exposure of the dependent lung to ventilator-induced lung injury (VILI). In addition, patients receiving thoracic surgeries are more prone to developing acute lung injuries due to direct surgery-related trauma caused by instrumentation or manipulation of the lung tissues, hypoperfusion induced by hypoxic pulmonary vasoconstriction, and dysfunction of surfactant system. The non-dependent lung is injured by surgical manipulation and atelectrauma. Re-expansion of the collapsed non-dependent lung at the end of surgery inevitably results in systemic inflammatory response in the local and contralateral lungs, which in turn leads to biotrauma. Therefore, a significantly high pulmonary complication of up to 14-28.4% was reported in patients that received OLV surgery.
In the recent two decades, there is a major paradigm shift for mechanical ventilator support during operation by the introduction of intraoperative lung protective ventilation strategies. Some of these changes include a low tidal volume (Vt), moderate levels of positive end-expiratory pressure (PEEP), optimal driving pressure (∆P) and the appropriate use of lung recruitment maneuver. Intraoperative lung protective ventilation strategies have been shown to reduce post-operative pulmonary complications and improve overall clinical outcomes in intermediate and high-risk patients undergoing major abdominal surgery. Currently, however, there is a lack of clinical evidence in regard to appropriate protective-lung strategies during OLV. The optimal levels of intraoperative use of oxygen fraction, the ventilatory settings for volume and pressure variables during OLV and re-expansion phases for lung recruitment are debating. The main objective of this clinical study is to determine the optimal levels of volume-pressure dynamics during OLV and at the phase of recruitment of the independent lungs by achieving optimal lung compliance, gas exchange and hemodynamics.
- Being tested
- Optimal lung compliance during OLV
- Keywords
- Barotrauma, Volutrauma, Biotrauma, Atelectasis, Lung recruitment
- Medical subject headings
- Ventilator-Induced Lung Injury, Barotrauma, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal lung compliance during OLVProcedure or surgery
Stepwise increase of tidal volume from 4 ml/kg PBW to 7 ml/kg PBW during OLV to determine the optimal tidal volume at the level the the pressure-volume loop reaches upper refection point where the peak airway pressure at or just below 30 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| One-lung ventilation | During one-lung ventilation, the dependent lung (non-operation lung) will be mechanically ventilated with a fixed positive end-expiratory pressure (PEEP) of 4 cmH2O and the peak pressure below 30 cmH2O. Tidal volumes will be titrated from the initial 4 ml/kg predicted body weight (PBW) to 7 ml/kg PBW. Optimal lung compliance is determined by the levels of upper reflection point of the pressure-volume loop closed to 30 cmH2O. Chest tomography will be undertaken with the optimal tidal volume during OLV phase and when the independent lung is completely recruited using the stepwise PEEP increase method. Receives: Procedure: Optimal lung compliance during OLV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal level of lung compliance during OLV
A tidal volume (4-7 ml/kg PBW) where the pressure-volume loop reaches upper refection point and the peak airway pressure at or just below 30 cmH2O
Measured: During the OLV phase of thoracic surgery
Secondary outcomes (1)
Postoperative pulmonary complication
Composite endpoints of clinical diagnoses of pneumonia, bronchospasm, and/or ARDS), radiological diagnoses of atelectasis, pneumothorax, and/or pleural effusion, and therapies for respiratory insufficiency (need for prolonged therapy after end of surgery by providing supplemental oxygen, postoperative noninvasive ventilation, and/or reintubation with postoperative mechanical ventilation.
Measured: 3 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Dec 2020
- Primary completion30 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tu, Yuan-Kun, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519606
- Sponsor's protocol ID
- EMRP69108N
- Status last verified
- Oct 2021
- First submitted
- 17 Aug 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 1. Intraoperative ventilatory mechanic parameters 2. Intraoperative hemodynamic measurements 3. Intraoperative chest computer tomographic images 4. Records of postoperative pulmonary complication rates
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Respiratory Mechanics During One-lung Ventilation
- ClinicalTrials.gov ID
- NCT04519606
- Acronym / sponsor ID
- EMRP69108N
- Keywords
- Barotrauma, Volutrauma, Biotrauma, Atelectasis, Lung recruitment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Aug 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.
Intraoperative lung protective ventilatory strategy has been widely recognized to reduce postoperative pulmonary complications in laparotomy and laparoscopic surgeries. However, the clinical evidence and consensus for ventilatory strategy to protect the dependent lung segments during thoracic surgery that requires one-lung ventilation (OLV) is currently not available. Since lung compliance changes significantly during OLV, the levels of respiratory mechanics should be optimized to avoid barotrauma and volutrauma. This study aims to determine the optimal levels of volume-pressure dynamics during OLV and at the phase of recruitment of the independent lungs by achieving optimal lung compliance, gas exchange and hemodynamics.
Detailed description
Background One-lung ventilation (OLV) is the foremost used technique of ventilation during thoracic procedures. Intraoperative lung separation can be managed by means of double-lumen endotracheal tube (DLT), bronchial blocker (BB), or nonintubated method. OLV is impeded by significant reduction in lung volume, decline in lung compliance at lateral decubital position, formation of intrapulmonary shunting and exposure of the dependent lung to ventilator-induced lung injury (VILI). In addition, patients receiving thoracic surgeries are more prone to developing acute lung injuries due to direct surgery-related trauma caused by instrumentation or manipulation of the lung tissues, hypoperfusion induced by hypoxic pulmonary vasoconstriction, and dysfunction of surfactant system. The non-dependent lung is injured by surgical manipulation and atelectrauma. Re-expansion of the collapsed non-dependent lung at the end of surgery inevitably results in systemic inflammatory response in the local and contralateral lungs, which in turn leads to biotrauma. Therefore, a significantly high pulmonary complication of up to 14-28.4% was reported in patients that received OLV surgery.
In the recent two decades, there is a major paradigm shift for mechanical ventilator support during operation by the introduction of intraoperative lung protective ventilation strategies. Some of these changes include a low tidal volume (Vt), moderate levels of positive end-expiratory pressure (PEEP), optimal driving pressure (∆P) and the appropriate use of lung recruitment maneuver. Intraoperative lung protective ventilation strategies have been shown to reduce post-operative pulmonary complications and improve overall clinical outcomes in intermediate and high-risk patients undergoing major abdominal surgery. Currently, however, there is a lack of clinical evidence in regard to appropriate protective-lung strategies during OLV. The optimal levels of intraoperative use of oxygen fraction, the ventilatory settings for volume and pressure variables during OLV and re-expansion phases for lung recruitment are debating. The main objective of this clinical study is to determine the optimal levels of volume-pressure dynamics during OLV and at the phase of recruitment of the independent lungs by achieving optimal lung compliance, gas exchange and hemodynamics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One-lung ventilation | – | Procedure: Optimal lung compliance during OLVDuring one-lung ventilation, the dependent lung (non-operation lung) will be mechanically ventilated with a fixed positive end-expiratory pressure (PEEP) of 4 cmH2O and the peak pressure below 30 cmH2O. Tidal volumes will be titrated from the initial 4 ml/kg predicted body weight (PBW) to 7 ml/kg PBW. Optimal lung compliance is determined by the levels of upper reflection point of the pressure-volume loop closed to 30 cmH2O. Chest tomography will be undertaken with the optimal tidal volume during OLV phase and when the independent lung is completely recruited using the stepwise PEEP increase method. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Generally healthy (ASA PC I-III) patients receiving thoracic surgery that required intraoperative OLV
Key inclusion criteria (3 listed)
- Scheduled for single lobectomy or wedge resection of right or left lung lobe
- American Society of Anesthesiologists physical classification (ASA PC) I-III
- Preoperative normal pulmonary function test
Key exclusion criteria (11 listed)
- Anticipated difficult intubation or ventilation
- Severe heart failure (NYHA Fc >=3)
- Advanced liver cirrhosis (Child-Pugh score >=B)
- Advanced renal disease (creatinine >2 mg/dl)
- Severe anemia (hemoglobin <8 mg/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 |
|---|---|---|
| Optimal lung compliance during OLVStepwise increase of tidal volume from 4 ml/kg PBW to 7 ml/kg PBW during OLV to determine the optimal tidal volume at the level the the pressure-volume loop reaches upper refection point where the peak airway pressure at or just below 30 cmH2O | Procedure or surgery | One-lung ventilation |
Primary outcome
Optimal level of lung compliance during OLV
Time frame: During the OLV phase of thoracic surgery
A tidal volume (4-7 ml/kg PBW) where the pressure-volume loop reaches upper refection point and the peak airway pressure at or just below 30 cmH2O
1 secondary outcome
Postoperative pulmonary complication
Time frame: 3 days after operation
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 7 Oct 2021.
- Individual participant dataSharing planned: Undecided. 1. Intraoperative ventilatory mechanic parameters 2. Intraoperative hemodynamic measurements 3. Intraoperative chest computer tomographic images 4. Records of postoperative pulmonary complication rates
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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?
An observational study of Ventilator-Induced Lung Injury and Lung Ventilator, run by E-DA Hospital at 1 site in Taiwan.
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 11 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 7 Oct 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 Taiwan. 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?
Optimal level of lung compliance during OLV (time frame: During the OLV phase of thoracic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2021.