NCT01636973

Brief Summary

A continuous loss of moisture and heat occurs during mechanical ventilation and prediposes patients to airway damage. Vaporizing humidifier has known to be advantages of improvement of oxygenation and protection of airway damage. However, there is a lack of study about the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation. We therefore invesgate that the effect of humidified ventilation on oxygenation and respiratory mechanics during one-lung ventilation .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Mar 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

March 1, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

10 months

First QC Date

July 5, 2012

Last Update Submit

July 9, 2012

Conditions

Lung Cancer

Keywords

Lung cancer

Outcome Measures

Primary Outcomes (1)

  • arterial oxygenation

    T1,T2,T3,T4: all measurement in lateral position, T1-arterial oxygenation(PaO2), T2-arterial oxygenation(PaO2),T3-arterial oxygenation(PaO2),T4-arterial oxygenation(PaO2)

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

Secondary Outcomes (1)

  • Respiratory dynamic parameters

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

Study Arms (1)

Vaporizing humidifier

EXPERIMENTAL

Vaporizing humidifier applying during one-lung ventilation

Procedure: Vaporizing humidifier

Interventions

Vaporizing humidifierPROCEDURE

Vaporizing humidifier applying during one-lung ventilation

Vaporizing humidifier

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status class I,II
  • Unilateral lung lobectomy
  • Use of one-lung ventilation

You may not qualify if:

  • COPD
  • CAOD
  • Unstable cardiovascular status
  • Peak inspiratory pressure \> 30 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, 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, M.D.,PhD.

    Yonsei University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

KR(1)