Impact of COVID-19 Pandemic on Intraoperative Ventilation Practices in Western Canada

NCT ID: NCT06821139

Last Updated: 2025-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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. new-normal era on LPV compliance, and interactions of predictors with pre-COVID vs. new-normal 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 "new normal" 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

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Lung Protective Ventilation Intraoperative Ventilation COVID COVID - 19 Non-cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

New normal 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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Perseus Missirlis

OTHER

Sponsor Role lead

Responsible Party

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Perseus Missirlis

Clinical instructor, staff anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Perseus Missirlis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Fraser Health Authority

Surrey, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 26332856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33724961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21552117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29606090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31587835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29985541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21045639 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H20-01683

Identifier Type: OTHER

Identifier Source: secondary_id

FHREB 2020-083

Identifier Type: -

Identifier Source: org_study_id

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