NCT06821139

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 14, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
Last Updated

March 9, 2026

Status Verified

February 1, 2025

Enrollment Period

10 years

First QC Date

January 14, 2025

Last Update Submit

March 6, 2026

Conditions

Keywords

lung protective ventilationintraoperative ventilationCanadianCOVIDnon-cardiac surgerypredictors

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fraser Health Authority

Surrey, British Columbia, V3T 0H1, Canada

Location

Related Publications (7)

  • 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.

    PMID: 26332856BACKGROUND
  • 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.

    PMID: 33724961BACKGROUND
  • 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.

    PMID: 21552117BACKGROUND
  • 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.

    PMID: 29606090BACKGROUND
  • 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.

    PMID: 31587835BACKGROUND
  • 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.

    PMID: 29985541BACKGROUND
  • 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.

    PMID: 21045639BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Perseus Missirlis, MD, MSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical instructor, staff anesthesiologist

Study Record Dates

First Submitted

January 14, 2025

First Posted

February 11, 2025

Study Start

January 1, 2014

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 9, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

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.

Locations