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

NCT ID: NCT02198625

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Hepatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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FiO2 80%,Nonprotective Lung Ventilation

Group Type NO_INTERVENTION

No interventions assigned to this group

FiO2 30%,Nonprotective Lung Ventilation

FiO2 30%,Nonprotective Lung Ventilation

Group Type EXPERIMENTAL

Moderate FiO2 and Protective Lung Ventilation Using

Intervention Type OTHER

FiO2 80%,protective Lung Ventilation

FiO2 80% and protective Lung Ventilation

Group Type EXPERIMENTAL

Moderate FiO2 and Protective Lung Ventilation Using

Intervention Type OTHER

FiO2 30%,protective Lung Ventilation

FiO2 30% and protective Lung Ventilation

Group Type EXPERIMENTAL

Moderate FiO2 and Protective Lung Ventilation Using

Intervention Type OTHER

Interventions

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Moderate FiO2 and Protective Lung Ventilation Using

Intervention Type OTHER

Eligibility Criteria

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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;
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fenmei Shi

OTHER

Sponsor Role lead

Responsible Party

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Fenmei Shi

resident

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fenmei Shi, M.M.

Role: CONTACT

Facility Contacts

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Ying Xiao, MD,PhD

Role: primary

Other Identifiers

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18826410080

Identifier Type: -

Identifier Source: org_study_id

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