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

July 3, 2013 updated by: Yongseon Choi, Yonsei University

Effects of Positive End-expiratory Pressure and Alveolar Recruitment on the Oxygenation and Respiratory Mechanics During One-lung Ventilation in the Supine Position

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II
  • age: 20-75 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
  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
8 cmH2O PEEP throughout the period of OLV and 2nd TLV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of anesthesia, an expected average of 3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of anesthesia, an expected average of 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: YONGSEON CHOI, Assistant Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Estimate)

July 4, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4-2011-0301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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