Positive End-expiratory Pressure and Alveolar Recruitment for One Lung Ventilation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yongseon Choi, Yonsei University

ClinicalTrials.gov Identifier:

NCT01652612

First received: December 20, 2011

Last updated: July 3, 2013

Last verified: July 2013

History of Changes

Purpose

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 .

Condition	Intervention
One Lung Ventilation	Other: PEEP


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Care Provider) Primary Purpose: Prevention
Official Title:	Effects of Positive End-expiratory Pressure and Alveolar Recruitment on the Oxygenation and Respiratory Mechanics During One-lung Ventilation in the Supine Position

Further study details as provided by Yongseon Choi, Yonsei University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

intrapulmonary shunt [ Time Frame: participants will be followed for the duration of anesthesia, an expected average of 3 hours ]
blood sampling after induction of anesthesia, 15 and 30 min after OLV, after the 2nd TLV


Enrollment:	99
Study Start Date:	August 2011
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Control zero PEEP
Experimental: OLV strategy: PEEP 1. apply 8 cm H2O positive end expiratory pressure during one lung ventilation and until the end of surgery	Other: PEEP 8 cmH2O PEEP throughout the period of OLV and 2nd TLV
Experimental: OLV strategy: PEEP followed by AR alveolar recruitment strategy before one lung ventilation 8 cmH2O positive end expiratory pressure during one lung ventilation and until the end of surgery	Other: PEEP 8 cmH2O PEEP throughout the period of OLV and 2nd TLV

Detailed Description:

outcome measures: respiratory parameters (Paw, Ppla, Compliance, Vd/Vt)and oxygenation parameters (PaO2, shunt fraction, Pa-AO2)

Eligibility


Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ASA I-II
age: 20-75 years

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652612

Locations


Korea, Republic of
Yong Seon Choi
Seoul, Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators


Principal Investigator:	Yongseon Choi	Assistant professor

More Information


Responsible Party:	Yongseon Choi, assistant professor, Yonsei University
ClinicalTrials.gov Identifier:	NCT01652612 History of Changes
Other Study ID Numbers:	4-2011-0301
Study First Received:	December 20, 2011
Last Updated:	July 3, 2013

Keywords provided by Yongseon Choi, Yonsei University:


positive end expiratory pressure

ClinicalTrials.gov processed this record on June 26, 2017

To Top