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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04978636
• Other study ID #: 21-447
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: Roberta Johnson
• Phone: 216/444/9950
• Email: johnsor13[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5502
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Hyperoxia

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
The Cleveland Clinic	Ohio State University, Society of Cardiovascular Anesthesiologists, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 30 days of surgery
Secondary	CPB time	Duration of cardiopulmonary bypass (STS defined)	During surgery
Secondary	ICU LOS	ICU length of stay (STS defined)	Within 30 days of surgery
Secondary	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	24 hours
Secondary	Hospital LOS	Hospital length of stay (STS defined)	Within 30 days of surgery
Secondary	Reintubation	Reintubation (STS defined)	Within 30 days of surgery
Secondary	Need for tracheostomy	Need for tracheostomy (STS defined)	Within 30 days of surgery
Secondary	Pleural effusion requiring drainage	Pleural effusion requiring drainage (STS defined)	Within 30 days of surgery
Secondary	Pneumonia	Pneumonia (STS defined)	Within 30 days of surgery
Secondary	Readmission	Readmission due to respiratory complication or need for thoracentesis and chest tube insertion (STS defined)	within 30 days of surgery
Secondary	30-day mortality	STS defined in hospital mortality	Within 30 days of surgery