One Lung Ventilation and Positive End Expiratory Pressure (PEEP)

This study is currently recruiting participants.

Verified July 2012 by Yonsei University

Sponsor:

Information provided by (Responsible Party):

Yong-Sun Choi, Yonsei University

ClinicalTrials.gov Identifier:

NCT01652612

First received: December 20, 2011

Last updated: July 25, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 20, 2011
Last Updated Date	July 25, 2012
Start Date ^ICMJE	August 2011
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 25, 2012)	PaO2, number of patients with hypoxia (PaO2< 90mmHg) [ Time Frame: participants will be followed for the duration of anesthesia, an expected average of 3 hours ] [ Designated as safety issue: Yes ] blood samplings after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01652612 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 25, 2012)	intrapulmonary shunt [ Time Frame: participants will be followed for the duration of anesthesia, an expected average of 3 hours ] [ Designated as safety issue: No ] blood sampling after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	One Lung Ventilation and Positive End Expiratory Pressure (PEEP)
Official Title ^ICMJE	Effects of Positive End-expiratory Pressure on the Oxygenation and Respiratory Mechanics During One-lung Ventilation in the Supine Position
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 .
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
Condition ^ICMJE	One Lung Ventilation
Intervention ^ICMJE	Other: PEEP 8 cmH2O PEEP throughout the period of OLV and 2nd TLV
Study Arm (s)	No Intervention: Control zero PEEP Experimental: OLV strategy: PEEP 1. apply 8 cm H2O positive end expiratoy pressure during one lung ventilation and until the end of surgery Intervention: Other: PEEP Experimental: OLV strategy: PEEP followed by AR alveolar recruitment strategy before one lung ventilation 8 cmH2O positve end expiratory pressure during one lung ventilation and until the end of surgery Intervention: Other: PEEP
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	90
Estimated Completion Date	December 2012
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: ASA I-II age: 20-75 years Exclusion Criteria: moderate to severe impaired respiratory function, heart failure, patients' refusal
Gender	Both
Ages	20 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01652612
Other Study ID Numbers ^ICMJE	4-2011-0301
Has Data Monitoring Committee	Yes
Responsible Party	Yong-Sun Choi, Yonsei University
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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