Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication

Fenmei Shi1 site in 1 country280 target enrollmentMarch 2014

ConditionsHepatectomy

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hepatectomy
Sponsor: Fenmei Shi
Enrollment: 280
Locations: 1
Primary Endpoint: a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the influence of moderate FiO2 and the lung protective ventilation on postoperative pulmonary complications following hepatic resection surgery.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

June 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fenmei Shi

Responsible Party

Sponsor Investigator

Principal Investigator

Fenmei Shi

resident

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

•ASA 1\~2,Planned intrabdominal hepatic resection surgery;
•Expected duration 2 hours to 6 hours;
•Age 40 yr to 70 yr);
•BMI 18-26.9kg/m2
•Risk of postoperative pulmonary complications (Arozullah score ≥2);

Exclusion Criteria

•Noninvasive ventilation in the last 30 days;
•Recent history of pneumonia, ALI/ARDS (in the last 30 days);
•History of pulmonary resection;
•History of neuromuscular disease;
•Child-Pugh\>A grade；
•Patient refusal;

Outcomes

Primary Outcomes

a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.

Time Frame: during the first seven days after surgery

The primary outcome was a composite of major pulmonary complications (defined as pneumonia or need for invasive or noninvasive ventilation for acute respiratory failure) and extrapulmonary complications (defined as sepsis, septic shock, or death) within the first 7 days after surgery.