NCT03061617

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

February 6, 2017

Last Update Submit

February 21, 2017

Conditions

Outcome Measures

Primary Outcomes (4)

  • Airway pressure Ppeak

    Airway pressure Ppeak in cmH2O.

    during procedure

  • Airway pressure Pplat

    Airway pressure Pplat in cmH2O.

    during procedure

  • oxygenation index

    Oxygenation index is calculated by PaO2/FiO2. PaO2 is measured by blood-gas analysis in mmHg. FiO2 is measured by gas monitor.

    during procedure

  • oxygenation index

    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%.

    surgery

Secondary Outcomes (1)

  • postoperative complications

    within 30 days after surgery

Study Arms (2)

volume controlled ventilation (VCV)

OTHER

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

Other: VCV mode

pressure controlled ventilation (PCV)

EXPERIMENTAL

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

Other: PCV mode

Interventions

set fixed 6ml/kg tide volume

volume controlled ventilation (VCV)

adjust pressure to achieve tide volume of 6ml/kg

pressure controlled ventilation (PCV)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

  • 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.

    PMID: 25368784BACKGROUND
  • 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.

    PMID: 26309682BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 23, 2017

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations