The Effect of Protective Ventilation During Pulmonary Lobectomy

Xuzhou Medical University1 site in 1 country120 target enrollmentJune 2, 2017

ConditionsPulmonary Complication Thoracic Surgery Inflammation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Pulmonary Complication
Sponsor: Xuzhou Medical University
Enrollment: 120
Locations: 1
Primary Endpoint: The proportion of patients with pulmonary complication
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in patients undergoing one-lung ventilation for pulmonary lobectomy.

Detailed Description

The hypothesis is that application of low tidal volume, moderate inspired oxygen fraction (FiO2) ,intermittent alveolar recruitment and positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in patients.

Registry

clinicaltrials.gov

Start Date

June 2, 2017

End Date

July 1, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xuzhou Medical University

Responsible Party

Principal Investigator

Su Liu

Principal Investigator

Xuzhou Medical University

Eligibility Criteria

Inclusion Criteria

•1.20 Years and older 2.Patients undergoing pulmonary lobectomy

Exclusion Criteria

•Emergency surgery
•Pulmonary hypertension
•Forced vital capacity or forced expiratory volume in 1 sec \< 50% of the predicted values
•Coagulation disorder
•Pulmonary or extrapulmonary infections
•History of treatment with steroid in 3 months before surgery
•History of recurrent pneumothorax
•History of lung resection surgery

Outcomes

Primary Outcomes

The proportion of patients with pulmonary complication

Time Frame: up to postoperative 3days

The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism.

Secondary Outcomes

IL6(10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
IL10(10 min after induction, 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)
PaO2 /FiO2(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery)
respiratory compliance(10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation)