RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-09-20

Study Completion:2025-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04978636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

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

Inclusion Criteria

Exclusion Criteria

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

* 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.

Contacts and Locations

Study Contact

Roberta Johnson

CONTACT

216/444/9950

johnsor13@gmail.com

Esra Kutlu, MD

CONTACT

216-445-7530

KUTLUYE@ccf.org

Principal Investigator

Marta Kelava, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Marta Kelava, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-20

Study Completion Date2025-03-30

Study Record Updates

Study Start Date2021-09-20

Study Completion Date2025-03-30

Terms related to this study

Additional Relevant MeSH Terms

Cardiac Surgery