- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06821139
Cohort Study of Intraoperative Lung Protective Ventilation Trends in a Large Canadian Health Authority
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3T 0H1
- Fraser Health Authority
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Perseus Missirlis, MD, MSc, University of British Columbia
Publications and helpful links
General Publications
- Canet 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.
- 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.
- Young 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.
- Parks 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.
- Kim 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.
- Guay 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.
- Blum 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHREB 2020-083
- H20-01683 (Other Identifier: University of British Columbia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID
-
Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRecruitingFatigue | Post-COVID-19 Syndrome | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19 | Long-COVID | Post-COVID ConditionCanada
-
Universidad Rey Juan CarlosNot yet recruitingPost COVID Syndrome | Long Covid | Long COVID Fatigue | Post COVID Syndrome Long Covid
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
European Institute of OncologyFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta; Azienda Ospedaliera... and other collaboratorsCompleted
-
Owlstone LtdCambridge University Hospitals NHS Foundation TrustCompleted
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Schön Klinik Berchtesgadener LandBavarian Health and Food Safety Authority (LGL)RecruitingPost COVID Syndrome | Post-COVID / Long-COVID | POST-Covid 19 | Post-COVID ConditionGermany
-
Assiut UniversityRecruiting
-
Jilin UniversityUnknown
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia