Who is sponsoring NCT04978636?

NCT04978636 is sponsored by The Cleveland Clinic.

What drugs are being tested in NCT04978636?

Interventions in NCT04978636: Continuous low-tidal volume ventilation with using FiO2 of 0.21, Continuous low tidal volume ventilation with using FiO2 of 1.0, Apnea During CPB.

What condition does NCT04978636 study?

NCT04978636 studies Cardiac Surgery.

Is NCT04978636 still recruiting?

NCT04978636 is currently active, enrolled. Last updated 30 December 2025.

Last reviewed 2025-12-30 · How we verify

NCT04978636

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled NA Last updated 30 December 2025

What this trial tests

NA trial testing Continuous low-tidal volume ventilation with using FiO2 of 0.21 in Cardiac Surgery in 5,502 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 September 2021

Primary endpoint
31 December 2026

30 March 2027

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	5,502
Start date	20 September 2021
Primary completion	31 December 2026
Estimated completion	30 March 2027
Sites	1 location across United States

Drugs / interventions tested

Continuous low-tidal volume ventilation with using FiO2 of 0.21
Continuous low tidal volume ventilation with using FiO2 of 1.0
Apnea During CPB

Conditions studied

Cardiac Surgery — all drugs for Cardiac Surgery →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

The role of CD38 in ischemia reperfusion injury in cardiopulmonary bypass and thoracic transplantation: a narrative review.
Gouchoe DA, Vijayakumar A, Aly AH, Cui EY, et al · · 2023 · PMID 37969313 · DOI 10.21037/jtd-23-725

Verify or expand the search:

Other recruiting trials for Cardiac Surgery

Currently open trials in the same condition.

NCT06968936 — Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy · NA · recruiting
NCT07417462 — Transversus Thoracic Muscle Plane Block Versus Pectointercostal Fascial Block for Enhanced Recovery After Cardiac Surger · NA · recruiting
NCT07193719 — Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children · Phase 1, PHASE2 · recruiting
NCT07116343 — Intrapleural Ropivacaine Infusion in Cardiac Surgery · Phase 4 · recruiting
NCT07354841 — Safety and Performance Evaluation of CPB Venous and Arterial Cannulas · NA · recruiting

Other The Cleveland Clinic trials

Trials by the same sponsor.

NCT07218198 — Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension · NA · not yet recruiting
NCT07442747 — Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS · NA · not yet recruiting
NCT07471464 — Centered Surgery - Preoperative Counseling and Patient Satisfaction · recruiting
NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
NCT07363343 — Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04978636 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
Last refreshed: 30 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04978636.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing