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

NCT02483806 | Completed

• 1 other identifier: 4-2015-0325
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

PEEP 0 cmH2O

EXPERIMENTAL

PEEP 0 cmH2O (zero end expiratory pressure, ZEEP)

Procedure: PEEP

PEEP 5 cmH2O

EXPERIMENTAL

Procedure: PEEP

EEP 10 cmH2O

EXPERIMENTAL

Procedure: PEEP

Interventions

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).

Also known as: Positive EndExpiratory Pressure breathing(PEEP)

EEP 10 cmH2O; PEEP 0 cmH2O; PEEP 5 cmH2O

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: June 29, 2015
• Study Start: June 29, 2015
• Primary Completion: May 25, 2016
• Study Completion: May 25, 2016
• Last Updated: December 28, 2017

Record last verified: 2017-12

Locations

KR (1)