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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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
  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

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)
Genders Eligible for Study:   Both
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
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
positive end expiratory pressure

ClinicalTrials.gov processed this record on September 29, 2016