Extubation Timing for Cardiac Surgery Recovery

Not yet recruiting at 1 trial location
Pd
AA
Overseen ByAhmad Alli, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether removing the breathing tube in the operating room after cardiac surgery helps adults recover faster than removing the breathing tube later in the intensive care unit (ICU), without increasing the risk of complications. The main questions it aims to answer are:

* Does planned operating-room extubation increase the amount of time patients are alive and free from breathing-machine support and significant blood-pressure or heart-support medications during the first 72 hours after surgery?

* Is planned operating-room extubation as safe as standard early ICU extubation with respect to important complications such as death, stroke, reoperation for bleeding, breathing failure requiring additional support or reintubation, and unplanned ICU readmission? Researchers will compare planned operating-room extubation with standard enhanced-recovery care in which patients remain intubated when leaving the operating room and are extubated in the ICU, with a target of within 6 hours after surgery when clinically appropriate.

Participants will:

* Provide informed consent before surgery

* Be randomly assigned to one of the two extubation strategies

* Receive otherwise standard cardiac surgical, anesthesia, and ICU care

* Have routine clinical information collected during the first 72 hours after surgery and through hospital discharge

* Complete a short questionnaire about their recovery on postoperative day 2

* Have their health status followed to 30 days after surgery If a participant assigned to operating-room extubation develops a clinical concern that makes immediate extubation unsafe, the treating team may keep the breathing tube in place and transfer the participant to the ICU while continuing standard care.

Who Is on the Research Team?

DM

David Mazer

Principal Investigator

Departments of Anesthesiology and Pain Medicine, Physiology, and Pharmacology and Toxicology at the University of Toronto

SV

Subodh Verma, MD PhD

Principal Investigator

Departments of Surgery, and Pharmacology and Toxicology at the University of Toronto

Are You a Good Fit for This Trial?

This trial is for adults scheduled for cardiac surgery who are able to give informed consent. It excludes those with specific medical reasons that would make early removal of the breathing tube unsafe, as determined by their care team.

Inclusion Criteria

I am having a specific type of aortic surgery, possibly with heart rhythm procedures.
I am having heart surgery with a heart-lung machine through my chest bone.
I am scheduled for planned or urgent heart surgery at a participating hospital.
See 4 more

Exclusion Criteria

I am expected to need a special airway procedure for anesthesia.
I have severe lung disease that makes safe early removal from a ventilator unlikely.
I needed a breathing machine before my surgery.
See 11 more

What Are the Treatments Tested in This Trial?

Interventions

  • Planned Operating-Room Extubation
  • Standard Early ICU Extubation

Trial Overview

The study compares two ways of removing the breathing tube after heart surgery: taking it out in the operating room right after surgery versus waiting until later in the ICU (within about 6 hours). Participants are randomly assigned to one group and receive standard care otherwise.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: Planned Operating-Room Extubation (ORE)Experimental Treatment1 Intervention
Group II: Arm B: Standard Early ICU ExtubationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Unity Health Toronto

Collaborator

Trials
572
Recruited
470,000+