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OpenTrials
Completed

NCT Number: NCT02483806

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP

Procedure

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 names: Positive EndExpiratory Pressure breathing(PEEP)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation: a Randomized Crossover Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Dec 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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