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Clinical Trials/NCT03061617
NCT03061617CompletedNot Applicable

Comparison of Pressure-controlled Ventilation With Volume-controlled Ventilation During One-lung Ventilation

Shanghai Zhongshan Hospital1 site in 1 country64 target enrollmentStarted: July 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
64
Locations
1
Primary Endpoint
Airway pressure Ppeak

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Airway pressure Ppeak

Time Frame: during procedure

Airway pressure Ppeak in cmH2O.

Airway pressure Pplat

Time Frame: during procedure

Airway pressure Pplat in cmH2O.

oxygenation index

Time Frame: 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 Outcomes

  • postoperative complications(within 30 days after surgery)

Investigators

Sponsor
Shanghai Zhongshan Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

JingCang

Professor

Shanghai Zhongshan Hospital

Study Sites (1)

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