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

NCT ID: NCT04978636

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

5502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2027-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Continuous low-tidal volume ventilation with using FiO2 of 0.21

The investigator will investigate the effect of continuous low tidal volume ventilation with hyperoxia avoidance (using FiO2 of 0.21) on PPCs and 30-day mortality compared to low-tidal volume ventilation (with FiO2 of 0.21) or apnea during CPB, and during the sub-study.

Group Type ACTIVE_COMPARATOR

Continuous low-tidal volume ventilation with using FiO2 of 0.21

Intervention Type OTHER

The continuous low-tidal volume ventilation with using FiO2 of 0.21 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 0.21 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.

Continuous low tidal volume ventilation with using FiO2 of 1.0

The investigator will investigate the effect of low tidal volume lung ventilation with hyperoxia avoidance (FiO2 of 0.21) on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or apnea during CPB, and during the sub-study.

Group Type ACTIVE_COMPARATOR

Continuous low tidal volume ventilation with using FiO2 of 1.0

Intervention Type OTHER

The continuous low-tidal volume ventilation with using FiO2 of 1.0 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 1.0 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.

Apnea

The investigator will investigate the effect of apnea during on PPCs and mortality compared to hyperoxic low-tidal volume ventilation (with FiO2 of 1.0) or hyperoxia avoidance (FiO2 of 0.21) during CPB, and during the sub-study..

Group Type ACTIVE_COMPARATOR

Apnea During CPB

Intervention Type OTHER

There will be no ventilation used. But, during the sub-study part of the Apnea CPB extra blood samples will be drawn before and after CPB.

Interventions

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Continuous low-tidal volume ventilation with using FiO2 of 0.21

The continuous low-tidal volume ventilation with using FiO2 of 0.21 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 0.21 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.

Intervention Type OTHER

Continuous low tidal volume ventilation with using FiO2 of 1.0

The continuous low-tidal volume ventilation with using FiO2 of 1.0 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 1.0 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients. During the sub-study extra blood samples will be drawn before and after CPB.

Intervention Type OTHER

Apnea During CPB

There will be no ventilation used. But, during the sub-study part of the Apnea CPB extra blood samples will be drawn before and after CPB.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>18 years of age
* Male and female patients undergoing elective cardiac surgeries requiring cardiopulmonary bypass.

Exclusion Criteria

Emergency surgeries, surgeries requiring lung isolation and one-lung ventilation (OLV), heart or lung transplants, and mechanical circulatory support device implantation pulmonary thrombendarterectomies.

* Surgeries requiring one-lung ventilation will be excluded because of the inability to employ study intervention and the differential treatment of the lungs likely confounding any potential effect from the planned intervention.
* Lung transplant surgeries will be excluded for similar reasons as well as other confounding effects affecting the primary composite outcome.
* Heart transplants and mechanical circulatory support device implantation surgeries will be excluded because these patients already receive intervention as part of the institutional protocol at the primary study site.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society of Cardiovascular Anesthesiologists

UNKNOWN

Sponsor Role collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Marta Kelava, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Kelava, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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21-447

Identifier Type: -

Identifier Source: org_study_id