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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483806
• Other study ID #: 4-2015-0325
• Status: Completed
• Phase: N/A
• First received: June 19, 2015
• Last updated: December 26, 2017
• Start date: June 29, 2015
• Est. completion date: May 25, 2016

Study information

• Verified date: December 2017
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 25, 2016
• Est. primary completion date: May 25, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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