Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

Xuzhou Medical University

Status: Unknown

Conditions: Pulmonary Complication; Thoracic Surgery

Treatments: Procedure: Driving Pressure Limited Ventilation; Procedure: Protective ventilation 1; Procedure: Protective ventilation 2

Study type: Interventional

Funder types: Other

Identifiers

NCT03177564

XYFY-2017-033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Protective Ventilation 1

Active Comparator group

Description:

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%.

Treatment:

Procedure: Protective ventilation 1

Protective Ventilation 2

Active Comparator group

Description:

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.

Treatment:

Procedure: Protective ventilation 2

Driving Pressure Limited Ventilation

Experimental group

Description:

The intervention arm receives driving pressure limited ventilation during one-lung ventilation

Treatment:

Procedure: Driving Pressure Limited Ventilation