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Procedure

Low Tidal Volume Ventilation for Cardiac Surgery

Q: Are new participants being enrolled in this scientific investigation?

Affirmative. Clinicaltrials.gov confirms that this trial, which originally debuted on September 20th 2021, is presently recruiting for 5502 participants at a single medical centre.

Q: What is the current enrollment of participants in this clinical trial?

Confirmed. According to the information on clinicaltrials.gov, the research study which was initially posted on September 20th 2021 is currently looking for participants. 5502 individuals are required from a single medical centre.

Q: What objectives has the clinical trial been designed to meet?

This 30 day trial will be assessing the frequency of a composite outcome, including STS-defined mortality and postoperative pulmonary complications. Reintubation (STS defined), early respiratory failure as PaO2/FiO2 ratio &#x3C;200 mmHg within 24 hours, and hospital length of stay (STS defined) are <a href="https://www.withpower.com/clinical-trials/all">all</a> secondary objectives.

N/A

Recruiting

Led By Marta Kelava, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female patients undergoing elective cardiac surgeries requiring cardiopulmonary bypass.

>18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of surgery

Awards & highlights

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.

Who is the study for?

Adults over 18 years old needing elective cardiac surgery with cardiopulmonary bypass can join. It's not for those requiring one-lung ventilation, emergency surgeries, lung or heart transplants, or mechanical circulatory support device implantation.Check my eligibility

What is being tested?

The FOCUS Trial is comparing two ways of helping patients breathe during heart surgery with a heart-lung machine: either using normal oxygen levels or high oxygen levels. Researchers will see which method is better for survival and lung health after surgery.See study design

What are the potential side effects?

Possible side effects may include lung complications due to different breathing strategies used during the operation. The impact on mortality and specific respiratory issues will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for heart surgery that will use a heart-lung machine.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications

Secondary outcome measures

30-day mortality

CPB time

Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission

+7 more

Other outcome measures

Postoperative reintubation

Trial Design

3Treatment groups

Active Control

Group I: ApneaActive Control1 Intervention

The investigator will investigate the effect of apnea during on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or hyperoxia avoidance (FiO2 of 0.21) during CPB, and during the sub-study..

Group II: Continuous low-tidal volume ventilation with using FiO2 of 0.21Active Control1 Intervention

The investigator will investigate the effect of continuous low tidal volume ventilation with hyperoxia avoidance (using FiO2 of 0.21) on PPCs and 30-day mortality compared to low-tidal volume ventilation (with FiO2 of 0.21) or apnea during CPB, and during the sub-study.

Group III: Continuous low tidal volume ventilation with using FiO2 of 1.0Active Control1 Intervention

The investigator will investigate the effect of low tidal volume lung ventilation with hyperoxia avoidance (FiO2 of 0.21) on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or apnea during CPB, and during the sub-study.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,360,056 Total Patients Enrolled

Society of Cardiovascular AnesthesiologistsUNKNOWN

2 Previous Clinical Trials

140 Total Patients Enrolled

University of Pittsburgh Medical CenterOTHER

70 Previous Clinical Trials

70,748 Total Patients Enrolled

Media Library

Continuous low-tidal volume ventilation with using FiO2 of 0.21 (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04978636 — N/A

Cardiac Surgery Research Study Groups: Apnea, Continuous low-tidal volume ventilation with using FiO2 of 0.21, Continuous low tidal volume ventilation with using FiO2 of 1.0

Cardiac Surgery Clinical Trial 2023: Continuous low-tidal volume ventilation with using FiO2 of 0.21 Highlights & Side Effects. Trial Name: NCT04978636 — N/A

Continuous low-tidal volume ventilation with using FiO2 of 0.21 (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04978636 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being enrolled in this scientific investigation?

"Affirmative. Clinicaltrials.gov confirms that this trial, which originally debuted on September 20th 2021, is presently recruiting for 5502 participants at a single medical centre."

Answered by AI

What is the current enrollment of participants in this clinical trial?

"Confirmed. According to the information on clinicaltrials.gov, the research study which was initially posted on September 20th 2021 is currently looking for participants. 5502 individuals are required from a single medical centre."

Answered by AI

What objectives has the clinical trial been designed to meet?

"This 30 day trial will be assessing the frequency of a composite outcome, including STS-defined mortality and postoperative pulmonary complications. Reintubation (STS defined), early respiratory failure as PaO2/FiO2 ratio <200 mmHg within 24 hours, and hospital length of stay (STS defined) are all secondary objectives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)

2021. "Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978636.