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

Hepatectomy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198625
• Other study ID #: 18826410080
• Status: Recruiting
• Phase: Phase 4
• First received: July 13, 2014
• Last updated: July 22, 2014
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2014
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Fenmei Shi, M.M.
• Email: shifenmei2006[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatectomy

Intervention

Other:
• Moderate FiO2 and Protective Lung Ventilation Using

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fenmei Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a composite of pulmonary and extrapulmonary complications occurring by day 7 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.	during the first seven days after surgery	Yes
Secondary	incidence of pulmonary complications	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;	within the 30-day follow-up period	Yes
Secondary	Oxidative stress markers	Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls.	2 days	No