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Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation

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ClinicalTrials.gov Identifier: NCT02483806
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary shunt can be increased resulting hypoxemia. Wang et al measured intrapulmonary shunt by transesophageal echocardiography. Although OLV technique had been advanced so far, hypoxemia during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Applying PEEP(Positive End-expiratory Pressure) at dependent lung and CPAP at non-dependent lung can mitigate the hypoxemia. Above all, PEEP can be easily applicable. However, there are controversial studies whether it is supportive or not. In this prospective, cross-over study, the investigators are planning to investigate the effects of PEEP on intrapulmonary shunt, oxygenation and cardiac function as well.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: PEEP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation: a Randomized Crossover Study
Actual Study Start Date : June 29, 2015
Actual Primary Completion Date : May 25, 2016
Actual Study Completion Date : May 25, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEEP 0 cmH2O
PEEP 0 cmH2O (zero end expiratory pressure, ZEEP)
Procedure: PEEP
After induction of anesthesia, including insertion of TEE probe, change position from supine to lateral position. Measure ABGA and cardiac indices for the baseline value. Apply each PEEP (0, 5, 10 cmH2O) serially at the random order. 6 sequences (0->5->10, 0->10->5, 5->10->0, 5->0->10, 10->5->0, 10->0->5) are equally applied to 6 patients (total 6x6=36 patients) who agreed to this study. Measure ABGA and cardiac indices after 20 min at each step of peep apply(3 times).
Other Name: Positive EndExpiratory Pressure breathing(PEEP)

Experimental: PEEP 5 cmH2O Procedure: PEEP
After induction of anesthesia, including insertion of TEE probe, change position from supine to lateral position. Measure ABGA and cardiac indices for the baseline value. Apply each PEEP (0, 5, 10 cmH2O) serially at the random order. 6 sequences (0->5->10, 0->10->5, 5->10->0, 5->0->10, 10->5->0, 10->0->5) are equally applied to 6 patients (total 6x6=36 patients) who agreed to this study. Measure ABGA and cardiac indices after 20 min at each step of peep apply(3 times).
Other Name: Positive EndExpiratory Pressure breathing(PEEP)

Experimental: EEP 10 cmH2O Procedure: PEEP
After induction of anesthesia, including insertion of TEE probe, change position from supine to lateral position. Measure ABGA and cardiac indices for the baseline value. Apply each PEEP (0, 5, 10 cmH2O) serially at the random order. 6 sequences (0->5->10, 0->10->5, 5->10->0, 5->0->10, 10->5->0, 10->0->5) are equally applied to 6 patients (total 6x6=36 patients) who agreed to this study. Measure ABGA and cardiac indices after 20 min at each step of peep apply(3 times).
Other Name: Positive EndExpiratory Pressure breathing(PEEP)




Primary Outcome Measures :
  1. the effect of differential PEEP (0, 5, 10 cmH2O) by PaO2(P/F ratio) [ Time Frame: 20 minutes after each PEEP apply ]
  2. Cardiac function [ Time Frame: 20 minutes after each PEEP apply ]
    cardiac function : Tei index



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for VATS lobectomy
  • 40 ≤ age ≤ 80
  • American Society of Anaesthesiologists(ASA) physical status classification I~III

Exclusion Criteria:

  • American Society of Anaesthesiologists(ASA) physical status classification IV
  • NYHA class III~IV
  • Severe obstructive lung disease and/or restrictive lung disease patients
  • those with end-organ diseases (i.e. heart failure, respiratory failure, hepatic failure, renal failure)
  • arrhythmia
  • esophageal varix
  • pregnant women

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): NCT02483806


Locations
Korea, Republic of
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02483806     History of Changes
Other Study ID Numbers: 4-2015-0325
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017