NCT02198625

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 23, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

July 13, 2014

Last Update Submit

July 22, 2014

Conditions

Hepatectomy

Keywords

Moderate FiO2Protective lung ventilationPostoperative pulmonary complicationsPositive end-expiratory pressurerecruitment maneuvers

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • incidence of pulmonary complications

    within the 30-day follow-up period

  • Oxidative stress markers

    2 days

Study Arms (4)

FiO2 80%,Nonprotective Lung Ventilation

NO INTERVENTION

FiO2 30%,Nonprotective Lung Ventilation

EXPERIMENTAL

FiO2 30%,Nonprotective Lung Ventilation

Other: Moderate FiO2 and Protective Lung Ventilation Using

FiO2 80%,protective Lung Ventilation

EXPERIMENTAL

FiO2 80% and protective Lung Ventilation

Other: Moderate FiO2 and Protective Lung Ventilation Using

FiO2 30%,protective Lung Ventilation

EXPERIMENTAL

FiO2 30% and protective Lung Ventilation

Other: Moderate FiO2 and Protective Lung Ventilation Using

Interventions

Moderate FiO2 and Protective Lung Ventilation UsingOTHER
FiO2 30%,Nonprotective Lung VentilationFiO2 30%,protective Lung VentilationFiO2 80%,protective Lung Ventilation

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Fenmei Shi, M.M.

CONTACT

shifenmei2006@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

July 13, 2014

First Posted

July 23, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

CN(1)