Lung Protective VentilationNCT06821139
Cohort Study of Intraoperative Lung Protective Ventilation Trends in a Large Canadian Health Authority
An observational study of Lung Protective Ventilation and Intraoperative Ventilation, run by Perseus Missirlis at 1 site in Canada.
Trial summary
The goal of this observational study is to ascertain the practice patterns and predictors in performing lung protective ventilation as per clinical guidelines for adult patients undergoing non-cardiac surgery in Fraser Health Authority, a large Canadian authority in the lower mainland of British Columbia, Canada. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Protective Ventilation, Intraoperative Ventilation, COVID
- How many people
- 28,700 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2014to 31 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from January 2014 to December 2023, age above 18, undergoing non-cardiac and non-thoracic surgery for greater than 30 minutes with an endotracheal tube placed. Both inpatients and outpatients are eligible.
Who may be able to join
- over the age of 18
- underwent general anesthesia with endotracheal tube placement for a procedure lasting ≥30 minutes.
- included in both our clinical anesthesia record database and the National Surgical Quality Improvement Program (NSQIP) database, and linkable by usual identifiers (name, date of birth, medical record number, personal health number, date of surgery)
Who cannot join
- no endotracheal tube utilized
- cardiothoracic surgery
- organ donation surgery
- organ transplant recipient
- Hyperthermic intraperitoneal chemotherapy
- surgical procedure related to an occurrence or complication of prior procedure during the same admission/within 30 days,
- multiple NSQIP assessed cases within 30 days only for same patient
- cases in clinical anesthesia record database that are unable to be linked to NSQIP data or vice versa.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to ascertain the practice patterns and predictors in performing lung protective ventilation as per clinical guidelines for adult patients undergoing non-cardiac surgery in Fraser Health Authority, a large Canadian authority in the lower mainland of British Columbia, Canada. In particular, the investigators explore changes before/after the COVID-19 pandemic. The main questions it aims to answer are:
- In this population, what is the general compliance rate to lung protective ventilation
- In this population, what are the predictors of compliance before/after the COVID-19 pandemic.
Read more
This is a retrospective study using linked patient data from two databases in the health region: the anesthesia informational management system for intraoperative data, and the electronic medical record for perioperative data.
Rationale for study:
Breathing problems after surgery affect 5% to 33% of patients and can lead to serious issues like lung infections, breathing failure, and longer hospital stays, with up to a 20% risk of death within 30 days for serious cases. A proven way to reduce these risks is lung protective ventilation (LPV), a technique used during surgery where the ventilator delivers smaller breaths based on clinical guidelines and calculated using a person's ideal body weight, while applying gentle pressure to keep the lungs slightly open. While this approach has been widely adopted in intensive care units over the past 20 years, it's less commonly used in operating rooms, with fewer than half of surgeries using it. Barriers include suboptimal default ventilator settings, patients at extremes of weight, and misunderstandings of LPV among clinicians. During the COVID-19 pandemic, LPV use increased for patients with COVID-related lung problems, showing improved survival rates in ICUs. However, it's unclear if this practice carried over to surgical patients at-large or continued after the pandemic. Most studies on LPV during surgery have been conducted outside Canada, where healthcare practices and education may differ from within Canada. To address these gaps, the investigators aim to study LPV use during surgery in a large Canadian health system, identify factors that influence its use, and examine trends during and after the COVID pandemic. This research will help improve patient care by promoting the use of this effective technique in Canadian operating rooms.
Read the detailed description
This observational study aims to elucidate the patterns and predictors of intraoperative lung protective ventilation (LPV) in adult patients undergoing non-cardiac surgery at Fraser Health Authority, a large Canadian health authority on the west coast of Canada, between 2014-2023. It also assesses the impact of pre-COVID vs. 2020s era on LPV compliance, and interactions of predictors with pre-COVID vs. 2020s era. LPV is defined as both 1) tidal volume of 6-8mL/kg ideal body weight and 2) positive end-expiratory pressure of 5 cmH2O or more. Intraoperative data will be derived from the intraoperative anesthesia information management system, and the perioperative data from the regional electronic medical record. The investigators will use a predictive logistic regression model to ascertain statistically significant predictors to LPV. Hypothesized predictors of LPV compliance based on literature and expert opinion will be considered for inclusion in the model. Pre-COVID and 2020s data will be compared, and interactions with predictors will be explored. As a secondary analysis, a Shewhart chart will be used to elucidate any special cause variation in LPV compliance introduced by the COVID pandemic. For details of descriptive analyses, model derivation, and Shewhart chart methodology, please refer to study protocol.
- Conditions
- Lung Protective Ventilation, Intraoperative Ventilation, COVID, COVID - 19, Non-cardiac Surgery
- Keywords
- lung protective ventilation, intraoperative ventilation, Canadian, COVID, non-cardiac surgery, predictors
- Medical subject headings
- COVID-19
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 |
|---|---|---|
| Pre-COVID cohort | Before January 2020. The investigators considered before January 2020 as the pre-COVID era, and after June 2020 as the COVID era. The former cutoff was chosen as January 2020 contained the first COVID case in British Columbia, the province containing the study sites. The latter cutoff was chosen as it constitutes three months after March 2020, when the World Health Organization (WHO) announced COVID's pandemic status, and British Columbia announced a state of emergency with the start of isolation policies. The investigators hypothesized that any impact of the COVID pandemic on lung protective ventilation practice patterns would unlikely to have occurred prior COVID's arrival in BC, but would likely be in full swing three months after initiation of widespread social isolation, a very palpable event in society. | |
| 2020s cohort | After June 2020. The investigators considered before January 2020 as the pre-COVID era, and after June 2020 as the COVID era. The former cutoff was chosen as January 2020 contained the first COVID case in British Columbia, the province containing the study sites. The latter cutoff was chosen as it constitutes three months after March 2020, when the WHO announced COVID's pandemic status, and British Columbia announced a state of emergency with the start of isolation policies. The investigators hypothesized that any impact of the COVID pandemic on lung protective ventilation practice patterns would unlikely to have occurred prior COVID's arrival in BC, but would likely be in full swing three months after initiation of widespread social isolation, a very palpable event in society. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung protective ventilation compliance
Compliance with ventilation guidelines is defined as meeting two criteria. The first is that their average tidal volume is 6-8 mL/kg ideal body weight and the second is that the average positive end expiratory pressure is at least 5 cm H2O. Patients ventilated according to one or neither of the above criteria will not be considered to have been ventilated according to established guidelines.
Measured: For patients not ventilated preoperatively: from insertion to removal of endotracheal tube (or until end of case if tube not removed). For already ventilated patients: from start to end of operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Jan 2014
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung Protective VentilationStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28,700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perseus Missirlis
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Sponsor-investigator, Perseus Missirlis, Fraser Health
- Investigators
- Perseus Missirlis, MD, MSc, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821139
- Sponsor's protocol ID
- FHREB 2020-083
- Other IDs
- H20-01683
- Status last verified
- May 2026
- First submitted
- 14 Jan 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data (IPD) is obtained from medical record registries at Fraser Health Authority. While IPD used in this study will not be shared, these data (and similar data at other time frames) are freely available to investigators of subsequent proposed studies, in collaboration with an investigator at Fraser Health Authority, through the usual data access application mandated by Fraser Health Authority.
Publications
Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.
PubMed 26332856Parks DA, Short RT, McArdle PJ, Liwo A, Hagood JM, Crump SJ, Bryant AS, Vetter TR, Morgan CJ, Beasley TM, Jones KA. Improving Adherence to Intraoperative Lung-Protective Ventilation Strategies Using Near Real-Time Feedback and Individualized Electronic Reporting. Anesth Analg. 2021 May 1;132(5):1438-1449. doi: 10.1213/ANE.0000000000005481.
PubMed 33724961Blum JM, Maile M, Park PK, Morris M, Jewell E, Dechert R, Rosenberg AL. A description of intraoperative ventilator management in patients with acute lung injury and the use of lung protective ventilation strategies. Anesthesiology. 2011 Jul;115(1):75-82. doi: 10.1097/ALN.0b013e31821a8d63.
PubMed 21552117Kim SH, Na S, Lee WK, Choi H, Kim J. Application of intraoperative lung-protective ventilation varies in accordance with the knowledge of anaesthesiologists: a single-Centre questionnaire study and a retrospective observational study. BMC Anesthesiol. 2018 Apr 2;18(1):33. doi: 10.1186/s12871-018-0495-7.
PubMed 29606090Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.
PubMed 31587835Guay J, Ochroch EA, Kopp S. Intraoperative use of low volume ventilation to decrease postoperative mortality, mechanical ventilation, lengths of stay and lung injury in adults without acute lung injury. Cochrane Database Syst Rev. 2018 Jul 9;7(7):CD011151. doi: 10.1002/14651858.CD011151.pub3.
PubMed 29985541Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
PubMed 21045639
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Intraoperative Lung Protective Ventilation Trends in a Large Canadian Health Authority
- ClinicalTrials.gov ID
- NCT06821139
- Acronym / sponsor ID
- FHREB 2020-083
- Conditions
- Lung Protective Ventilation, Intraoperative Ventilation, COVID, COVID - 19, Non-cardiac Surgery
- Keywords
- lung protective ventilation, intraoperative ventilation, Canadian, COVID, non-cardiac surgery, predictors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,700 participants (actual)
- Lead sponsor
- Perseus MissirlisUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Feb 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.
The goal of this observational study is to ascertain the practice patterns and predictors in performing lung protective ventilation as per clinical guidelines for adult patients undergoing non-cardiac surgery in Fraser Health Authority, a large Canadian authority in the lower mainland of British Columbia, Canada. In particular, the investigators explore changes before/after the COVID-19 pandemic. The main questions it aims to answer are:
- In this population, what is the general compliance rate to lung protective ventilation
- In this population, what are the predictors of compliance before/after the COVID-19 pandemic.
This is a retrospective study using linked patient data from two databases in the health region: the anesthesia informational management system for intraoperative data, and the electronic medical record for perioperative data.
Rationale for study:
Breathing problems after surgery affect 5% to 33% of patients and can lead to serious issues like lung infections, breathing failure, and longer hospital stays, with up to a 20% risk of death within 30 days for serious cases. A proven way to reduce these risks is lung protective ventilation (LPV), a technique used during surgery where the ventilator delivers smaller breaths based on clinical guidelines and calculated using a person's ideal body weight, while applying gentle pressure to keep the lungs slightly open. While this approach has been widely adopted in intensive care units over the past 20 years, it's less commonly used in operating rooms, with fewer than half of surgeries using it. Barriers include suboptimal default ventilator settings, patients at extremes of weight, and misunderstandings of LPV among clinicians. During the COVID-19 pandemic, LPV use increased for patients with COVID-related lung problems, showing improved survival rates in ICUs. However, it's unclear if this practice carried over to surgical patients at-large or continued after the pandemic. Most studies on LPV during surgery have been conducted outside Canada, where healthcare practices and education may differ from within Canada. To address these gaps, the investigators aim to study LPV use during surgery in a large Canadian health system, identify factors that influence its use, and examine trends during and after the COVID pandemic. This research will help improve patient care by promoting the use of this effective technique in Canadian operating rooms.
Detailed description
This observational study aims to elucidate the patterns and predictors of intraoperative lung protective ventilation (LPV) in adult patients undergoing non-cardiac surgery at Fraser Health Authority, a large Canadian health authority on the west coast of Canada, between 2014-2023. It also assesses the impact of pre-COVID vs. 2020s era on LPV compliance, and interactions of predictors with pre-COVID vs. 2020s era. LPV is defined as both 1) tidal volume of 6-8mL/kg ideal body weight and 2) positive end-expiratory pressure of 5 cmH2O or more. Intraoperative data will be derived from the intraoperative anesthesia information management system, and the perioperative data from the regional electronic medical record. The investigators will use a predictive logistic regression model to ascertain statistically significant predictors to LPV. Hypothesized predictors of LPV compliance based on literature and expert opinion will be considered for inclusion in the model. Pre-COVID and 2020s data will be compared, and interactions with predictors will be explored. As a secondary analysis, a Shewhart chart will be used to elucidate any special cause variation in LPV compliance introduced by the COVID pandemic. For details of descriptive analyses, model derivation, and Shewhart chart methodology, please refer to study protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-COVID cohort | – | –Before January 2020. The investigators considered before January 2020 as the pre-COVID era, and after June 2020 as the COVID era. The former cutoff was chosen as January 2020 contained the first COVID case in British Columbia, the province containing the study sites. The latter cutoff was chosen as it constitutes three months after March 2020, when the World Health Organization (WHO) announced COVID's pandemic status, and British Columbia announced a state of emergency with the start of isolation policies. The investigators hypothesized that any impact of the COVID pandemic on lung protective ventilation practice patterns would unlikely to have occurred prior COVID's arrival in BC, but would likely be in full swing three months after initiation of widespread social isolation, a very palpable event in society. |
| 2020s cohort | – | –After June 2020. The investigators considered before January 2020 as the pre-COVID era, and after June 2020 as the COVID era. The former cutoff was chosen as January 2020 contained the first COVID case in British Columbia, the province containing the study sites. The latter cutoff was chosen as it constitutes three months after March 2020, when the WHO announced COVID's pandemic status, and British Columbia announced a state of emergency with the start of isolation policies. The investigators hypothesized that any impact of the COVID pandemic on lung protective ventilation practice patterns would unlikely to have occurred prior COVID's arrival in BC, but would likely be in full swing three months after initiation of widespread social isolation, a very palpable event in society. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from January 2014 to December 2023, age above 18, undergoing non-cardiac and non-thoracic surgery for greater than 30 minutes with an endotracheal tube placed. Both inpatients and outpatients are eligible.
Key inclusion criteria (3 listed)
- over the age of 18
- underwent general anesthesia with endotracheal tube placement for a procedure lasting ≥30 minutes.
- included in both our clinical anesthesia record database and the National Surgical Quality Improvement Program (NSQIP) database, and linkable by usual identifiers (name, date of birth, medical record number, personal health number, date of surgery)
Key exclusion criteria (8 listed)
- no endotracheal tube utilized
- cardiothoracic surgery
- organ donation surgery
- organ transplant recipient
- Hyperthermic intraperitoneal chemotherapy
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
Lung protective ventilation compliance
Time frame: For patients not ventilated preoperatively: from insertion to removal of endotracheal tube (or until end of case if tube not removed). For already ventilated patients: from start to end of operation.
Compliance with ventilation guidelines is defined as meeting two criteria. The first is that their average tidal volume is 6-8 mL/kg ideal body weight and the second is that the average positive end expiratory pressure is at least 5 cm H2O. Patients ventilated according to one or neither of the above criteria will not be considered to have been ventilated according to established guidelines.
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 1 Jun 2026.
- Background: PubMed 26332856Bender SP, Paganelli WC, Gerety LP, Tharp WG, Shanks AM, Housey M, Blank RS, Colquhoun DA, Fernandez-Bustamante A, Jameson LC, Kheterpal S. Intraoperative Lung-Protective Ventilation Trends and Practice Patterns: A Report from the Multicenter Perioperative Outcomes Group. Anesth Analg. 2015 Nov;121(5):1231-9. doi: 10.1213/ANE.0000000000000940.
- Background: PubMed 33724961Parks DA, Short RT, McArdle PJ, Liwo A, Hagood JM, Crump SJ, Bryant AS, Vetter TR, Morgan CJ, Beasley TM, Jones KA. Improving Adherence to Intraoperative Lung-Protective Ventilation Strategies Using Near Real-Time Feedback and Individualized Electronic Reporting. Anesth Analg. 2021 May 1;132(5):1438-1449. doi: 10.1213/ANE.0000000000005481.
- Background: PubMed 21552117Blum JM, Maile M, Park PK, Morris M, Jewell E, Dechert R, Rosenberg AL. A description of intraoperative ventilator management in patients with acute lung injury and the use of lung protective ventilation strategies. Anesthesiology. 2011 Jul;115(1):75-82. doi: 10.1097/ALN.0b013e31821a8d63.
- Background: PubMed 29606090Kim SH, Na S, Lee WK, Choi H, Kim J. Application of intraoperative lung-protective ventilation varies in accordance with the knowledge of anaesthesiologists: a single-Centre questionnaire study and a retrospective observational study. BMC Anesthesiol. 2018 Apr 2;18(1):33. doi: 10.1186/s12871-018-0495-7.
- Background: PubMed 31587835Young CC, Harris EM, Vacchiano C, Bodnar S, Bukowy B, Elliott RRD, Migliarese J, Ragains C, Trethewey B, Woodward A, Gama de Abreu M, Girard M, Futier E, Mulier JP, Pelosi P, Sprung J. Lung-protective ventilation for the surgical patient: international expert panel-based consensus recommendations. Br J Anaesth. 2019 Dec;123(6):898-913. doi: 10.1016/j.bja.2019.08.017. Epub 2019 Oct 3.
- Background: PubMed 29985541Guay J, Ochroch EA, Kopp S. Intraoperative use of low volume ventilation to decrease postoperative mortality, mechanical ventilation, lengths of stay and lung injury in adults without acute lung injury. Cochrane Database Syst Rev. 2018 Jul 9;7(7):CD011151. doi: 10.1002/14651858.CD011151.pub3.
- Background: PubMed 21045639Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
- Individual participant dataSharing planned: No. Individual patient data (IPD) is obtained from medical record registries at Fraser Health Authority. While IPD used in this study will not be shared, these data (and similar data at other time frames) are freely available to investigators of subsequent proposed studies, in collaboration with an investigator at Fraser Health Authority, through the usual data access application mandated by Fraser Health Authority.
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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.
Perseus Missirlis, MD, MSc principal investigator
University of British Columbia
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 Lung Protective Ventilation and Intraoperative Ventilation, run by Perseus Missirlis at 1 site in Canada.
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 8 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 1 Jun 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 Canada. 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?
Lung protective ventilation compliance (time frame: For patients not ventilated preoperatively: from insertion to removal of endotracheal tube (or until end of case if tube not removed). For already ventilated patients: from start to end of operation.). 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 NCT06821139, which also lists 7 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 1 Jun 2026.