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

Phase 4

• Conditions: Hepatectomy
• Interventions: Other: Moderate FiO2 and Protective Lung Ventilation Using

• Registration Number: NCT02198625
• Lead Sponsor: Fenmei Shi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-07
• Study First Submitted: 2014-07-13
• Study First Submitted QC: 2014-07-22
• Last Update Submitted: 2014-07-22
• Study First Posted: 2014-07-23
• Last Update Posted: 2014-07-23
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FiO2 30%,Nonprotective Lung Ventilation	Moderate FiO2 and Protective Lung Ventilation Using	FiO2 30%,Nonprotective Lung Ventilation
FiO2 80%,protective Lung Ventilation	Moderate FiO2 and Protective Lung Ventilation Using	FiO2 80% and protective Lung Ventilation
FiO2 30%,protective Lung Ventilation	Moderate FiO2 and Protective Lung Ventilation Using	FiO2 30% and protective Lung Ventilation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
incidence of pulmonary complications	within the 30-day follow-up period	the incidence of pulmonary complications due to any cause, graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications);extrapulmonary complications; durations of ICU and hospital stays;
Oxidative stress markers	2 days	Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls.

Trial Locations

Locations (1)

First Affiliated Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China