Comparison of Different Ventilation Mode During One-lung Ventilation

Not Applicable

Completed

• Conditions: Thoracic Surgery; Ventilator-Induced Lung Injury; One Lung Ventilation
• Interventions: Other: PCV mode; Other: VCV mode

• Registration Number: NCT03061617
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

It is controversial as to which ventilation mode is better in one-lung ventilation(OLV), volume controlled ventilation(VCV) or pressure controlled ventilation(PCV). This study was designed to figure out if there was any difference between these two modes on oxygenation and postoperative complications under the condition of protective ventilation(PV).

Detailed Description

This is a single center, single blinded prospective study on two different ventilation mode during one lung ventilation for patients under video assistant thoracoscopy(VATS) lobectomy. After institutional approval and written informed consent were obtained, 60 patients with primary lung cancer under VATS lobectomy in Zhongshan Hospital Fudan University were enrolled and randomized into two groups:VCV group(group V) or PCV group(group P).

Inclusion criteria were age between 18-75 years , ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1\>50% predicted. Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-02
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-21
• Last Update Submitted: 2017-02-21
• Study First Posted: 2017-02-23
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• ASA I-II, lateral decubitus position with at least 1h OLV and preoperative FEV1>50% predicted

Exclusion Criteria

• Preoperative exclusion criteria were previous lobectomy , COPD , asthma, uncompensated cardiac disease or contraindications for epidural catheter. Intraoperative exclusion criteria were SpO2 under 90% after intratracheal suction, reconfirmation the position of double lumen tracheal tube(DLT) and recruitment maneuver of dependant lungs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pressure controlled ventilation (PCV)	PCV mode	PCV mode, pressure is adjusted to achieve tide volume 6ml/kg, f 12-14
volume controlled ventilation (VCV)	VCV mode	VCV mode, tide volume 6ml/kg, f 12-14, set fixed tide volume for each breath

Primary Outcome Measures

Name	Time	Method
Airway pressure Ppeak	during procedure	Airway pressure Ppeak in cmH2O.
Airway pressure Pplat	during procedure	Airway pressure Pplat in cmH2O.
oxygenation index	surgery	Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is calculated by \[21+4×oxygen flow(L/min)\]×100%.

Secondary Outcome Measures

Name	Time	Method
postoperative complications	within 30 days after surgery	including air leak, pneumonia, bronchopleural fistula, respiratory failure, ARDS, reintubation, tracheostomy, pulmonary embolism, arrhythmia requiring treatment, myocardial infarction, renal dysfunction, central neurologic event, sepsis, unexpected return to operating room, unexpected ICU admission and mortality within 30 days

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China