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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: PEEP

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Positive EndExpiratory Pressure breathing(PEEP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effect of differential PEEP (0, 5, 10 cmH2O) by PaO2(P/F ratio)		20 minutes after each PEEP apply
Cardiac function	cardiac function : Tei index	20 minutes after each PEEP apply

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2015
• Primary Completion (Actual): May 25, 2016
• Study Completion (Actual): May 25, 2016

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Actual): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 26, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 4-2015-0325