Operating Room Extubation for Cardiac Surgery

Not yet recruiting at 1 trial location
LG
JB
Overseen ByJordan Bloom, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether removing the breathing tube immediately after heart surgery in the operating room aids recovery better than removing it later in the intensive care unit. Researchers compare two methods: removing the tube in the operating room (OR extubation) and removing it within six hours after surgery in the ICU (ICU extubation). The trial targets adults scheduled for elective heart surgery who are low-risk and fit for immediate waking and extubation post-procedure. Participants should not have major lung issues, severe overweight, serious sleep apnea, or other specified conditions. As an unphased trial, this study provides a unique opportunity to enhance understanding of best practices for post-surgery recovery.

What prior data suggests that extubation in the operating room is safe for cardiac surgery patients?

Research has shown that removing the breathing tube in the operating room after heart surgery is safe. Studies have found that this practice leads to positive outcomes. For instance, one study found that all patients who had the tube removed in the operating room survived for at least 30 days, with only about 2.9% needing the tube reinserted. Another study found that this practice was safe and effective for certain patients, particularly those undergoing heart bypass surgery. These patients often spent less time in the ICU and incurred lower medical costs. Overall, evidence suggests that this method is well-tolerated and can help many people recover faster after heart surgery.12345

Why are researchers excited about this trial?

Researchers are excited about the trial comparing ICU extubation and OR extubation for cardiac surgery because it explores the potential benefits of removing the breathing tube right in the operating room, rather than waiting until the patient is in the ICU. This approach could mean faster recovery times, as patients might regain full consciousness and breathing autonomy more quickly. Additionally, it could lead to reduced ICU stays, freeing up critical resources and potentially lowering healthcare costs.

What evidence suggests that OR extubation is effective for postoperative recovery after cardiac surgery?

Research has shown that removing the breathing tube in the operating room after heart surgery, one of the approaches studied in this trial, can be safe and effective. Studies found no deaths within 30 days among patients who had their breathing tube removed in the operating room, and only about 2.9% required reintubation. This trial will compare this approach to extubation in the intensive care unit (ICU), another arm of the study. Some studies suggest that operating room extubation might lead to better outcomes, such as shorter hospital stays and reduced medication use. However, not all research agrees; some studies found no clear benefits and even suggested possible increased risks. Overall, results indicate it is a safe option for certain patients, but opinions vary.678910

Are You a Good Fit for This Trial?

This trial is for adults (18+) scheduled for elective heart surgery with low surgical risk, who are considered suitable by their surgeon to have the breathing tube removed in the operating room. People with serious lung or muscle diseases, certain heart or airway problems, sleep apnea needing home devices, or those having complex surgeries can't join.

Inclusion Criteria

I am 18 or older and scheduled for heart surgery with a heart-lung machine.
Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator
Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon
See 1 more

Exclusion Criteria

I have a lung disease that requires me to use oxygen at home.
I have been diagnosed with pre-capillary pulmonary hypertension on my latest heart test.
I am having surgery to remove blood clots from my lung arteries.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo cardiac surgery followed by extubation either in the operating room or in the ICU

Immediate post-surgery
1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative recovery, including extubation outcomes and ICU stay

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including days at home and any readmissions

15 days

What Are the Treatments Tested in This Trial?

Interventions

  • ICU extubation
  • OR extubation

Trial Overview

The study compares two ways of removing the breathing tube after heart surgery: either right in the operating room as soon as surgery ends, or later in the intensive care unit. Patients are randomly assigned to one of these groups to see which method helps recovery more safely.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: OR extubationActive Control1 Intervention
Group II: ICU extubationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41692628/

Operating Room Extubation After Cardiac Surgery

All ORE patients survived for 30 days. Reintubation occurred in 5 patients (2.9%). zero 30-day mortality,

Operating Room Extubation After Cardiac Surgery

On average 28% of eligible cases were extubated. All ORE patients survived for 30 days. Reintubation occurred in 5 patients (2.9%). zero 30-day mortality,

Comparison of Short-Term Outcomes of Extubation...

Extubating in the operating room after adult cardiac surgery safely improves outcomes and lowers costs.

Operating Room Extubation After Cardiac Surgery

The authors found that among other positive outcomes, patients undergoing ORE had a shorter LOS, a lower vasoactive inotropic score (VIS), less ...

A National Society of Thoracic Surgeons Database Analysis

Conclusions: Extubation in the OR was safe and effective in a selected patient population and may be associated with superior outcomes in coronary artery bypass ...

Operating Room Extubation After Cardiac Surgery

All ORE patients survived for 30 days. Reintubation occurred in 5 patients (2.9%). Median ICU stay was shorter for ORE patients compared with ...

Operating Room Extubation for Patients Undergoing ...

Extubation in the OR was safe and effective in a selected patient population and may be associated with superior outcomes in coronary artery bypass, aortic ...

Extubating in the operating room after adult cardiac surgery ...

Conclusions. After cardiac surgery, OR extubation is safe and might provide improvement in length of stay and cost compared with early postoperative ICU ...

Operating Room Extubation in Major Aortic Surgery

Safety outcomes included major complications and mortality. Among 658 patients, 191 (29%) were extubated in the OR and 467 (71%) were ...

Comparison of Short-Term Outcomes of Extubation in the ...

Objectives: This study aimed to compare short-term outcomes in patients extubated in the operating room (ORE) vs those extubated in the ...