Comparison of Different Ventilation Mode During One-lung Ventilation

NCT ID: NCT03061617

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Thoracic Surgery; One Lung Ventilation; Ventilator-Induced Lung Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

volume controlled ventilation (VCV)

VCV mode, tide volume 6ml/kg, f 12-14, set fixed tide volume for each breath

Group Type: OTHER

VCV mode

Intervention Type: OTHER

set fixed 6ml/kg tide volume

pressure controlled ventilation (PCV)

PCV mode, pressure is adjusted to achieve tide volume 6ml/kg, f 12-14

Group Type: EXPERIMENTAL

PCV mode

Intervention Type: OTHER

adjust pressure to achieve tide volume of 6ml/kg

Interventions

VCV mode

set fixed 6ml/kg tide volume

Intervention Type: OTHER

PCV mode

adjust pressure to achieve tide volume of 6ml/kg

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

JingCang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Song SY, Jung JY, Cho MS, Kim JH, Ryu TH, Kim BI. Volume-controlled versus pressure-controlled ventilation-volume guaranteed mode during one-lung ventilation. Korean J Anesthesiol. 2014 Oct;67(4):258-63. doi: 10.4097/kjae.2014.67.4.258. Epub 2014 Oct 27.

Reference Type: BACKGROUND

PMID: 25368784 (View on PubMed)

Lin F, Pan L, Qian W, Ge W, Dai H, Liang Y. Comparison of three ventilatory modes during one-lung ventilation in elderly patients. Int J Clin Exp Med. 2015 Jun 15;8(6):9955-60. eCollection 2015.

Reference Type: BACKGROUND

PMID: 26309682 (View on PubMed)

Other Identifiers

B2012-064

Identifier Type: -

Identifier Source: org_study_id