Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

Not Applicable

• Conditions: Pulmonary Complication; Thoracic Surgery
• Interventions: Procedure: Protective ventilation 1; Procedure: Protective ventilation 2; Procedure: Driving Pressure Limited Ventilation

• Registration Number: NCT03177564
• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University

Brief Summary

This study aims to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients undergoing one-lung ventilation during Video-assisted thoracoscopic lobectomy.

Detailed Description

• More recently, the so-called lung-protective intraoperative ventilation strategies have been advocated to prevent lung injury. Such strategies aim at minimizing lung hyperinflation as well as cycling collapse and reopening of lung units, through the use of low tidal volumes (VTs) and positive end-expiratory pressure (PEEP). However, despite huge improvements in surgical and anesthesia techniques and management. It is surprising that, so far, mortality and pulmonary complication rates were not reduced over time .Recently, several investigations suggest an association between high driving pressure (the difference between the plateau pressure and the level of PEEP) and outcome for patients with acute respiratory distress syndrome. It is uncertain whether a similar association exists for high driving pressure during surgery and the occurrence of postoperative pulmonary complications. In this issue, Ary S Neto and colleagues report an individual patient data meta-analysis further investigating the risk of mechanical ventilation in healthy individuals during general anesthesia .After both a multivariate and mediation analysis, the driving pressure, but not the tidal volume or the positive end-expiratory pressure applied, seemed to be the only parameter that was associated with the development of postoperative pulmonary complications. This randomized controlled trial is aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-04
• Study Start: 2017-06-05
• Study First Submitted QC: 2017-06-05
• Last Update Submitted: 2017-06-05
• Study First Posted: 2017-06-06
• Last Update Posted: 2017-06-06
• Primary Completion: 2018-06-10
• Study Completion: 2018-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Adults greater than or equal to 18 years
2. ARISCAT（Assess Respiratory Risk in Surgical Patients in Catalonia）≥26 points
3. Patients undergoing video-assisted thoracoscopic lobectomy

Exclusion Criteria

1. The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
2. Emergency surgery
3. Pulmonary hypertension
4. Forced vital capacity or forced expiratory volume in 1 sec < 70% of the predicted values
5. Coagulation disorder
6. Pulmonary or extrapulmonary infections
7. History of treatment with steroid in 3 months before surgery
8. History of recurrent pneumothorax
9. History of lung resection surgery
10. History of mechanical ventilation in 2 weeks
11. Body Mass Index[≥35 kg／m2 ]
12. Patient who is contraindicated with application of positive end expiratory pressure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protective Ventilation 1	Protective 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 of100%.
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 5cmH2O and a FiO2 of 60% with lung recruitment maneuvers.
Driving Pressure Limited Ventilation	Driving Pressure Limited Ventilation	The intervention arm receives driving pressure limited ventilation during one-lung ventilation

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative pulmonary complications	within the first 3 days after surgery	Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.

Secondary Outcome Measures

Name	Time	Method
Partial pressure of oxygen in arterial blood	15 min after induction, 20 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	during surgery	Dynamic compliance, Static compliance
TNF-α	the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
IL-8	the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation
ICU mortality	Patients will be followed during the period of hospital stay, an expected average of 28 days
In-hospital mortality	Patients will be followed during the period of hospital stay, an expected average of 28 days
28-day survival	From day 0 to day 28

Trial Locations

Locations (1)

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