๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-22

Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial) (NCT04978636)

The eFfect of cOntinuous Low Tidal Volume Ventilation With Hyperoxia Avoidance During CardiopUlmonary Bypass "FOCUS" Trial Blood Samples

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: The Cleveland Clinic

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Cleveland Clinic Foundation โ€” Cleveland, Ohio

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • 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)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Cleveland Clinic Foundation โ€” Cleveland, Ohio

๐Ÿ“ž Contact the Study Coordinator

Phone: (866) 223-8100

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Cardiac Surgery clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—