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

Primary Purpose

Cardiac Surgery

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Continuous low-tidal volume ventilation with using FiO2 of 0.21

Continuous low tidal volume ventilation with using FiO2 of 1.0

Apnea

Arm Description

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.

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.

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..

Outcomes

Primary Outcome Measures

Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications
Composite including STS 30-day mortality and postoperative pulmonary complications defined a early respiratory failure defined as PaO2/FiO2 ratio<200 mmHg at any time within the first 24 hours of ICU admission, postoperative reintubation during the hospital stay, prolonged ventilation, pneumonia, pleural effusion requiring drainage, pneumothorax requiring intervention, and readmission due to: pleural effusion requiring intervention, or pneumonia.

Secondary Outcome Measures

CPB time
Duration of cardiopulmonary bypass (STS defined)
ICU LOS
ICU length of stay (STS defined)
Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
Hospital LOS
Hospital length of stay (STS defined)
Reintubation
Reintubation (STS defined)
Need for tracheostomy
Need for tracheostomy (STS defined)
Pleural effusion requiring drainage
Pleural effusion requiring drainage (STS defined)
Pneumonia
Pneumonia (STS defined)
Readmission
Readmission due to respiratory complication or need for thoracentesis and chest tube insertion (STS defined)
30-day mortality
STS defined in hospital mortality

Full Information

First Posted
July 20, 2021
Last Updated
June 15, 2023
Sponsor
The Cleveland Clinic
Collaborators
Society of Cardiovascular Anesthesiologists, University of Pittsburgh Medical Center, Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04978636
Brief Title
Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)
Official Title
The eFfect of cOntinuous Low Tidal Volume Ventilation With Hyperoxia Avoidance During CardiopUlmonary Bypass "FOCUS" Trial Blood Samples
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
Society of Cardiovascular Anesthesiologists, University of Pittsburgh Medical Center, Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5502 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous low-tidal volume ventilation with using FiO2 of 0.21
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Continuous low tidal volume ventilation with using FiO2 of 1.0
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Apnea
Arm Type
Active Comparator
Arm Description
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..
Intervention Type
Other
Intervention Name(s)
Continuous low-tidal volume ventilation with using FiO2 of 0.21
Intervention Description
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
Intervention Name(s)
Continuous low tidal volume ventilation with using FiO2 of 1.0
Intervention Description
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
Intervention Name(s)
Apnea During CPB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of Composite including STS 30 day Mortality and postoperative pulmonary complications
Description
Composite including STS 30-day mortality and postoperative pulmonary complications defined a early respiratory failure defined as PaO2/FiO2 ratio<200 mmHg at any time within the first 24 hours of ICU admission, postoperative reintubation during the hospital stay, prolonged ventilation, pneumonia, pleural effusion requiring drainage, pneumothorax requiring intervention, and readmission due to: pleural effusion requiring intervention, or pneumonia.
Time Frame
Within 30 days of surgery
Secondary Outcome Measure Information:
Title
CPB time
Description
Duration of cardiopulmonary bypass (STS defined)
Time Frame
During surgery
Title
ICU LOS
Description
ICU length of stay (STS defined)
Time Frame
Within 30 days of surgery
Title
Early respiratory failure - PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
Description
PaO2/FiO2 ratio < 200 mmHg at any time within the first 24 hours of ICU admission
Time Frame
24 hours
Title
Hospital LOS
Description
Hospital length of stay (STS defined)
Time Frame
Within 30 days of surgery
Title
Reintubation
Description
Reintubation (STS defined)
Time Frame
Within 30 days of surgery
Title
Need for tracheostomy
Description
Need for tracheostomy (STS defined)
Time Frame
Within 30 days of surgery
Title
Pleural effusion requiring drainage
Description
Pleural effusion requiring drainage (STS defined)
Time Frame
Within 30 days of surgery
Title
Pneumonia
Description
Pneumonia (STS defined)
Time Frame
Within 30 days of surgery
Title
Readmission
Description
Readmission due to respiratory complication or need for thoracentesis and chest tube insertion (STS defined)
Time Frame
within 30 days of surgery
Title
30-day mortality
Description
STS defined in hospital mortality
Time Frame
Within 30 days of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Johnson
Phone
216/444/9950
Email
johnsor13@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Kutlu, MD
Phone
216-445-7530
Email
KUTLUYE@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta Kelava, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta Johnson
Phone
216-444-9950
Email
johnsor13@ccf.org
First Name & Middle Initial & Last Name & Degree
Esra Kutlu, MD
Phone
216-445-7530
Email
KUTLUYE@ccf.org
First Name & Middle Initial & Last Name & Degree
Marta Kelava, MD

12. IPD Sharing Statement

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

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