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

Fenmei Shi

Status and phase: Unknown; Phase 4

Conditions: Hepatectomy

Treatments: Other: Moderate FiO2 and Protective Lung Ventilation Using

Study type: Interventional

Funder types: Other

Identifiers

NCT02198625

18826410080

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 4 patient groups

FiO2 80%,Nonprotective Lung Ventilation

No Intervention group

FiO2 30%,Nonprotective Lung Ventilation

Experimental group

Description:

FiO2 30%,Nonprotective Lung Ventilation

Treatment:

Other: Moderate FiO2 and Protective Lung Ventilation Using

FiO2 80%,protective Lung Ventilation

Experimental group

Description:

FiO2 80% and protective Lung Ventilation

Treatment:

Other: Moderate FiO2 and Protective Lung Ventilation Using

FiO2 30%,protective Lung Ventilation

Experimental group

Description:

FiO2 30% and protective Lung Ventilation

Treatment:

Other: Moderate FiO2 and Protective Lung Ventilation Using