NCT04458337

Brief Summary

Overall mortality of COVID-19 is variable and has been reported to be between less than 1% and 7%. Many authors around the world also reported data on hospitalization rate, need for intensive care unit (ICU) care and need for mechanical ventilation in SARS-CoV-2 infected patients. To provide anesthetic and surgical care to SARS-CoV-2 infected patients, many health workers have to organize surgical platforms, personal protections and in-hospital trajectories to prevent dissemination and cross-contamination. However, no data has been published on the surgical need of these patients, their postoperative outcomes and the impact they may have on the operating room. Postoperative outcomes in SARS-CoV-2 infected patients seem to be variable. Expected benefits from a surgical procedure may be different in this population if their postoperative mortality is higher than expected. The association between preoperative characteristics and postoperative outcomes in this population has to be better defined. There is a need to better quantify these and better inform use of surgical resources during a pandemic. To address this knowledge gap, the investigators propose to conduct a multicenter observational cohort study in SARS-CoV-2 infected patients undergoing a surgical procedure, as well as in those who have recovered from COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration 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

March 13, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2022

Completed
Last Updated

July 12, 2022

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

June 26, 2020

Last Update Submit

July 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital survival

    Survival was calculated from the date of participant randomization to the date of participant death due to any cause. If the participant was discharged from the hospital and not seen afterwards, the date of hospital discharge was entered as the last day seen alive.

    30 days post-operation

Secondary Outcomes (12)

  • Occurrence of postoperative respiratory complications

    30 days post-operation

  • Occurrence of postoperative non-pulmonary infectious complications

    30 days post-operation

  • Occurrence of acute kidney injury (AKI)

    30 days post-operation

  • Occurrence of postoperative thromboembolic complications

    30 days post-operation

  • The need for a new postoperative ICU admission

    30 days post-operation

  • +7 more secondary outcomes

Study Arms (1)

SARS-CoV-2 patients undergoing a surgical procedure

The investigators propose to conduct a prospective observational cohort study on all patients suspected or confirmed being infected to SARS-CoV-2, or recovered from SARS-CoV-2, undergoing a surgery.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients (children and adults) confirmed being infected to SARS-CoV-2 will be included, as well as patients who have recovered, undergoing a surgical procedure in designated Canadian Centers. The investigators will include all patients up to 30th day of April 2021.

You may qualify if:

  • all patients undergoing a surgery with either a SARS-CoV-2 clinical suspicion based on reported symptoms during the pandemic (fever, myalgia, fatigue, cough, dyspnea, respiratory failure, diarrhea, vomiting, abdominal pain) or without any suggestive symptoms AND a SARS-CoV-2 confirmed infection with RT-PCR before surgery or within 72 hours after surgery. Patients who have recovered from SARS-CoV-2 infection will also be included. All patients up to 30th day of April 2021 will be included.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (2)

  • Amzallag E, Panchadsaram T, Girard M, Lecluyse V, Couture E, D'Aragon F, Kandelman S, Turgeon AF, Jodoin C, Beaulieu P, Richebe P, Carrier FM. Pulmonary complications and mortality among COVID-19 patients undergoing a surgery: a multicentre cohort study. BMJ Open. 2024 Nov 21;14(11):e090158. doi: 10.1136/bmjopen-2024-090158.

  • Carrier FM, Amzallag E, Lecluyse V, Cote G, Couture EJ, D'Aragon F, Kandelman S, Turgeon AF, Deschamps A, Nitulescu R, Djade CD, Girard M, Beaulieu P, Richebe P. Postoperative outcomes in surgical COVID-19 patients: a multicenter cohort study. BMC Anesthesiol. 2021 Jan 12;21(1):15. doi: 10.1186/s12871-021-01233-9.

MeSH Terms

Conditions

COVID-19Postoperative Complications

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • François-Martin Carrier, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 7, 2020

Study Start

March 13, 2020

Primary Completion

March 13, 2022

Study Completion

April 13, 2022

Last Updated

July 12, 2022

Record last verified: 2021-09

Locations