Continuous low tidal volume ventilation with using FiO2 of 1.0 for Cardiac Surgery

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cardiac SurgeryApnea During CPB - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing different ways to ventilate patients during heart surgery to see if it affects post-operative complications or mortality rates.

Eligible Conditions
  • Cardiac Surgery

Treatment Effectiveness

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Within 30 days of surgery

24 hours
Early respiratory failure
Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
Postoperative reintubation
30 day
Mortality
During surgery
CPB time
Day 30
30-day mortality
Hospital LOS
ICU LOS
Need for tracheostomy
Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications
Pleural effusion requiring drainage
Pneumonia
Reintubation
Day 30
Readmission

Trial Safety

Trial Design

3 Treatment Groups

Continuous low tidal volume ventilation with using FiO2 of 1.0
1 of 3
Apnea
1 of 3
Continuous low-tidal volume ventilation with using FiO2 of 0.21
1 of 3

Active Control

5502 Total Participants · 3 Treatment Groups

Primary Treatment: Continuous low tidal volume ventilation with using FiO2 of 1.0 · No Placebo Group · N/A

Continuous low tidal volume ventilation with using FiO2 of 1.0
Other
ActiveComparator Group · 1 Intervention: Continuous low tidal volume ventilation with using FiO2 of 1.0 · Intervention Types: Other
Apnea
Other
ActiveComparator Group · 1 Intervention: Apnea During CPB · Intervention Types: Other
Continuous low-tidal volume ventilation with using FiO2 of 0.21
Other
ActiveComparator Group · 1 Intervention: Continuous low-tidal volume ventilation with using FiO2 of 0.21 · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 30 days of surgery

Who is running the clinical trial?

Society of Cardiovascular AnesthesiologistsUNKNOWN
1 Previous Clinical Trials
40 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
950 Previous Clinical Trials
1,404,300 Total Patients Enrolled
Ohio State UniversityOTHER
715 Previous Clinical Trials
459,126 Total Patients Enrolled
University of Pittsburgh Medical CenterOTHER
56 Previous Clinical Trials
67,696 Total Patients Enrolled
Marta Kelava, MDPrincipal InvestigatorThe Cleveland Clinic

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are older than 18 years.
Patients who need to have a cardiac surgery that will require them to go on a heart and lung machine are typically male or female.