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Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
NCT04978636 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04978636
The ClinicalTrials.gov registry entry for NCT04978636 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,502 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 607 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04978636 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04978636?
This trial is sponsored by The Cleveland Clinic, which has 607 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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