NCT01540201

Brief Summary

Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with lung protective strategy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 25, 2013

Status Verified

December 1, 2013

Enrollment Period

8 months

First QC Date

February 16, 2012

Last Update Submit

December 24, 2013

Conditions

Lung CancerOne Lung VentilationGas ExchangeInverse-ratio Ventilation

Keywords

one lung ventilationgas exchangeinverse-ratio ventilation

Outcome Measures

Primary Outcomes (5)

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    10 minutes after induction of general anesthesia

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    30 minutes after start of one-lung ventilation

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    60 minutes after start of one-lung ventilation

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    15 min after restart of TLV

  • arterial CO2 partial pressure

    arteial CO2 partial pressure

    1 hour after the end of surgery

Secondary Outcomes (12)

  • arterial O2 partial pressure

    10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery

  • Mean airway pressure

    10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

  • tidal volume (exhaled)

    10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

  • hemodynamic parameters

    10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

  • end-tidal CO2 partial pressure

    10 min after induction, 30 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation

  • +7 more secondary outcomes

Study Arms (2)

1:2 group

ACTIVE COMPARATOR

conventional I:E ratio group, inspiratory time : expiratory time = 1:1

Other: Conventional I:E ratio

1:1 group

EXPERIMENTAL

inspiratory time : expiratory time = 1:1

Other: I:E = 1:1 ratio

Interventions

Conventional I:E ratioOTHER

conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model

Also known as: I:E ratio of 1:2, Ventilator : Datex-Ohmeda Aestiva/5 ® model
1:2 group
I:E = 1:1 ratioOTHER

I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model

Also known as: I:E ratio of 1:1, Ventilator : Datex-Ohmeda Aestiva/5 ® model
1:1 group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing elective lung lobectomy surgery.
  • the duration of one-lung ventilation is more than one hour.
  • subjects with more than twenty years old.

You may not qualify if:

  • subjects with past history of pneumothorax, asthma
  • Age under 20, more than 70 years.
  • Patients with ischemic heart disease, valvular heart disease
  • patients with hemodynamic unstability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sangmin M. Lee, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Won Ho Kim, MD

    Samsung Medical Center

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 28, 2012

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 25, 2013

Record last verified: 2013-12

Locations

KR(1)