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

NCT ID: NCT02483806

Last Updated: 2017-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-29

Study Completion Date

2016-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PEEP 0 cmH2O

PEEP 0 cmH2O (zero end expiratory pressure, ZEEP)

Group Type EXPERIMENTAL

PEEP

Intervention Type 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).

PEEP 5 cmH2O

Group Type EXPERIMENTAL

PEEP

Intervention Type 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).

EEP 10 cmH2O

Group Type EXPERIMENTAL

PEEP

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Other Intervention Names

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Positive EndExpiratory Pressure breathing(PEEP)

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2015-0325

Identifier Type: -

Identifier Source: org_study_id