NCT01499212

Brief Summary

The purpose of this study is to investigate effect of increasing inspiratory time (I:E ratio 1:1) on intrapulmonary shunt fraction and oxygenation during one lung ventilation in the lateral decubitus position.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable lung-cancer

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, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
Last Updated

December 26, 2011

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

December 18, 2011

Last Update Submit

December 21, 2011

Conditions

Lung CancerLung Lobectomy

Outcome Measures

Primary Outcomes (1)

  • intrapulmonary shunt fraction

    T1,T2,T3,T4 : ALL mesurement in lateral decubitus position T1-intrapulmonary shunt T2-intrapulmonary shunt T3-intrapulmonary shunt T4-intrapulmonary shunt

    T1 (10min before one lung ventibation)T2 (30min after one lung ventilation started)T3 (60min after one lung ventilation started)T4 (10min after two lung ventilation)

Secondary Outcomes (1)

  • Respiratory dynamic parameters

    T1,T2,T3,T4 (same as primary outcome measure)

Study Arms (1)

I:E ratio 1:1

EXPERIMENTAL
Procedure: I:E ratio

Interventions

I:E ratioPROCEDURE

I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg

I:E ratio 1:1

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status class I, II
  • Use of Double lumen tube
  • Unilateral lung lobectomy

You may not qualify if:

  • COPD
  • CAOD
  • Unstable hemodynamic status
  • Peak airway pressure \> 30mmHg (Two lung ventilation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Young Jun Oh, MD,PhD

    Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2011

First Posted

December 26, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

December 26, 2011

Record last verified: 2011-12

Locations

KR(1)