Protective Ventilation During Pulmonary Lobectomy

Not Applicable

• Conditions: Pulmonary Complication; Thoracic Surgery; Inflammation
• Interventions: Procedure: Convential Ventilation 1; Procedure: Protective Ventilation 2; Procedure: Protective Ventilation 1; Procedure: Convential Ventilation 2

• Registration Number: NCT03174743
• Lead Sponsor: Xuzhou Medical University

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.

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Status Verified: 2017-06
• Study Start: 2017-06-02
• Study First Posted: 2017-06-02
• Last Update Submitted: 2017-06-04
• Last Update Posted: 2017-06-06
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1.20 Years and older 2.Patients undergoing pulmonary lobectomy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Convential Ventilation 1	Convential Ventilation 1	Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of 60%.
Protective ventilation 2	Protective Ventilation 2	Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers.
Protective ventilation 1	Protective Ventilation 1	Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers.
Convential Ventilation 2	Convential Ventilation 2	Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of100%.

Primary Outcome Measures

Name	Time	Method
The proportion of patients with pulmonary complication	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 Outcome Measures

Name	Time	Method
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	Dynamic compliance, Static compliance

Trial Locations

Locations (1)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China