Protective Ventilation During Pulmonary Lobectomy

Xuzhou Medical University

Status: Unknown

Conditions: Inflammation; Pulmonary Complication; Thoracic Surgery

Treatments: Procedure: Protective Ventilation 2; Procedure: Convential Ventilation 2; Procedure: Protective Ventilation 1; Procedure: Convential Ventilation 1

Study type: Interventional

Funder types: Other

Identifiers

NCT03174743

XYFY-2017-033

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Convential Ventilation 1

Placebo 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 of 60%.

Treatment:

Procedure: Convential Ventilation 1

Convential Ventilation 2

Placebo 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: Convential Ventilation 2

Protective ventilation 1

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 6 cmH2O and a FiO2 of 60% with lung recruitment maneuvers.

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 6 cmH2O and a FiO2 of 100% with lung recruitment maneuvers.

Treatment:

Procedure: Protective Ventilation 2