NCT01652612

Brief Summary

Hypoxia frequently develops during one lung ventilation in the supine position.The objective of this article is to study the impact of preemptive alveolar recruitment and subsequent positive end expiratory pressure on arterial oxygenation and lung mechanics during one lung ventilation in the supine position in patients undergoing thoracic surgery .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

July 4, 2013

Status Verified

July 1, 2013

Enrollment Period

1.5 years

First QC Date

December 20, 2011

Last Update Submit

July 3, 2013

Conditions

One Lung Ventilation

Keywords

positive end expiratory pressure

Outcome Measures

Primary Outcomes (1)

  • PaO2, number of patients with hypoxia (PaO2< 90mmHg)

    blood samplings after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV

    participants will be followed for the duration of anesthesia, an expected average of 3 hours

Secondary Outcomes (1)

  • intrapulmonary shunt

    participants will be followed for the duration of anesthesia, an expected average of 3 hours

Study Arms (3)

Control

NO INTERVENTION

zero PEEP

OLV strategy: PEEP

EXPERIMENTAL

1\. apply 8 cm H2O positive end expiratory pressure during one lung ventilation and until the end of surgery

Other: PEEP

OLV strategy: PEEP followed by AR

EXPERIMENTAL

1. alveolar recruitment strategy before one lung ventilation 2. 8 cmH2O positive end expiratory pressure during one lung ventilation and until the end of surgery

Other: PEEP

Interventions

PEEPOTHER

8 cmH2O PEEP throughout the period of OLV and 2nd TLV

OLV strategy: PEEPOLV strategy: PEEP followed by AR

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • age: 20-75 years

You may not qualify if:

  • moderate to severe impaired respiratory function,
  • heart failure,
  • patients' refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yong Seon Choi

Seoul, Seoul, South Korea

Location

Study Officials

  • Yongseon Choi

    Assistant professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 20, 2011

First Posted

July 30, 2012

Study Start

August 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

July 4, 2013

Record last verified: 2013-07

Locations

KR(1)