Intra-operative Fraction of Inspired Oxygen and Lung Injury in Coronary Artery Bypass Grafting Surgery

NCT04115501 | Withdrawn DMC

• 1 other identifier: 19.0988
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective observer blinded, central randomization controlled, multi-center clinical trial to assess the relationship between intraoperative FiO2 and postoperative pulmonary complications with lung injury.

Conditions

Lung Injury; Pulmonary Complication

Outcome Measures

Primary Outcomes (1)

• arterial PO2/FiO2 Ratio

  minimal postoperative arterial PO2/FiO2 Ratio

  48hr post operation

Secondary Outcomes (4)

• Pulmonary complications

  up to one week while in the hospital

• length of mechanical ventilation

  up to one week while in the hospital

• length of postoperative ICU stay

  up to one week while in the hospital

• length of hospital stay

  up to one week while in the hospital

Study Arms (2)

Restrictive Oxygen

EXPERIMENTAL

The restrictive oxygen patients' Fraction of Inspired Oxygen (FiO2) will be set at a minimum of 0.3 to maintain their oxygen saturations (SpO2) greater than or equal to 95% intraoperatively. During CPB a blended air/oxygen mixture will be titrated to arterial blood gas analysis with aim of maintenance of PaO2 between 100 and 150 mmHg. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation.

Other: Fraction of Inspired Oxygen

Liberal Oxygen

NO INTERVENTION

The liberal oxygen group will consist of subjects exposed to a Fraction of Inspired Oxygen (FiO2) set at 1.0 throughout the intraoperative period, including during cardiopulmonary bypass. After transfer to ICU, all patients' FiO2 will be set to 50% initially, and titrate to minimal FiO2 (not less than 21%) for maintain SPO2≥95% until extubation.

Interventions

Fraction of Inspired Oxygen OTHER

Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass

Restrictive Oxygen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75
• BMI from 20 to 39.9
• ASA II/III
• Undergoing isolated selective on-pump CABG through median sternotomy
• Subsequent admission to an intensive care unit (ICU).

You may not qualify if:

• with severe chronic obstructive pulmonary disease (COPD)
• Pregnant woman.
• With current acute coronary syndrome (\<1 week)
• Severe anemia (hemoglobin \<10g/L)
• Preoperative supplemental oxygen requirement to maintain arterial O2 of 92%,
• Right to left shunt in heart
• Carotid stenosis defined as \>50% stenosis of either carotid artery,
• Cardiac surgery that requires intraoperative circulatory arrest,
• Current use of dialysis,
• One-lung ventilation during surgery,
• Recent smoking (within 1 month),
• Non-respiratory reason to reintubate or delayed extubation such as bleeding or heart failure,
• Perioperative allogenic transfusion with red blood cell, plasma or platelet

Sponsors & Collaborators

• University of Louisville: lead
• Peking Union Medical College Hospital: collaborator
• Tianjin Chest Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Peking University People's Hospital: collaborator

Study Sites (1)

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Jiapeng Huang, MD, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research fellows and ICU physicians who record and assess the primary and secondary outcomes will be blinded to the group assignment. The principal investigator (PI) of every center and the physicians who conduct the anesthesia and monitoring intraoperatively in operating room are unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: February 27, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)