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

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ClinicalTrials.gov Identifier: NCT01652612
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
Yongseon Choi, Yonsei University

Study Description
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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 .

Condition or disease Intervention/treatment Phase
One Lung Ventilation Other: PEEP Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (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
Study Start Date : August 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yongseon Choi, assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01652612     History of Changes
Other Study ID Numbers: 4-2011-0301
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: July 2013

Keywords provided by Yongseon Choi, Yonsei University:
positive end expiratory pressure