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NCT04978636 · ClinicalTrials.gov registry record · NA
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
A NA study of Cardiac Surgery, sponsored by The Cleveland Clinic.
- Active
- Registry status
- NA
- Development phase
- 5,502
- Enrollment target
- 1
- Study location
NCT04978636: Active NA study of Cardiac Surgery, sponsored by The Cleveland Clinic.
NCT04978636 is a NA study of Cardiac Surgery that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 5,502 participants, above the 456-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (1107% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04978636, a NA study of Cardiac Surgery, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 5,502 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels.
Primary Outcome
Composite including STS 30-day mortality and postoperative pulmonary complications defined a early respiratory failure defined as PaO2/FiO2 ratio\<200 mmHg at any time within the first 24 hours of ICU admission, postoperative reintubation during the hospital stay, prolonged ventilation, pneumonia, pleural effusion requiring drainage, pneumothorax requiring intervention, and readmission due to: pleural effusion requiring intervention, or pneumonia.
Conditions Studied
Interventions
- OTHER Continuous low-tidal volume ventilation with using FiO2 of 0.21
- OTHER Continuous low tidal volume ventilation with using FiO2 of 1.0
- OTHER Apnea During CPB
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,502 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
What the registry record for NCT04978636 still lists
NCT04978636 is an interventional study that assigns participants to a tested intervention. Its 5,502 participants enrollment target places it among the larger protocols in the corpus, above the 456-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (1107% higher).
The record links to 1 condition, with Cardiac Surgery appearing as the primary indexed condition, and to 3 interventions - of which Continuous low-tidal volume ventilation with using FiO2 of 0.21 is the first listed.
NCT04978636 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04978636 about?
NCT04978636 is a clinical study titled "Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)". This is a multi-institutional study (CCF, UPMC, OSU) evaluating different ventilation strategies during cardiopulmonary bypass on mortality and postoperative pulmonary complications, with sub-study investigating 8-iso-prostaglandin F2a and sRAGE levels.
What is the current status of trial NCT04978636?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 5,502 participants. The study started on 2021-09-20. Estimated completion is 2027-03-30.
What conditions does trial NCT04978636 study?
This clinical trial studies the following conditions: Cardiac Surgery.
What interventions are being tested in trial NCT04978636?
The interventions under investigation include: Continuous low-tidal volume ventilation with using FiO2 of 0.21 (OTHER), Continuous low tidal volume ventilation with using FiO2 of 1.0 (OTHER), Apnea During CPB (OTHER).
Who is sponsoring clinical trial NCT04978636?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04978636 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04978636's enrollment target sits among peer trials
5,502 1st of 19 higher than 19 of 19 other Cardiac Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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