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

Cardiac Surgery Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The investigators will evaluate the effect of low tidal volume with varying FiO2 fractions during cardiopulmonary bypass on postoperative mortality and pulmonary complications. This will be a prospective, pragmatic, cluster randomized trial including all eligible adult cardiac surgical patients requiring cardiopulmonary bypass. Each week, all operating rooms will be randomized to one of three possible ventilation strategies during the period of cardiopulmonary bypass: 1) continuous low tidal volume ventilation with inspired oxygen fraction at 1.0, 2) continuous low tidal volume ventilation with inspired oxygen fraction at 0.21, and 3) no ventilation (apnea). The investigators will anticipate increase in plasma sRAGE and 8-iso-prostaglandin F2a levels in all three groups of patients during CPB with the highest levels immediately after cross-clamp release. The investigators will anticipate significant difference with at least 25% lower sRAGE levels in this group. The sub-study will also provide preliminary data on the behavior of the 8-iso-prostaglandin F2a which will be useful in further investigation of other targeted interventions to reduce ischemia-reperfusion injury to the lung during routine cardiac surgical operations. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04978636
Study type Interventional
Source The Cleveland Clinic
Contact Roberta Johnson
Phone 216/444/9950
Email johnsor13@gmail.com
Status Recruiting
Phase N/A
Start date September 20, 2021
Completion date March 30, 2025
View Details
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