Differential Lung Ventilation vs. CPAP

June 9, 2018 updated by: Dr Michal Barak, Rambam Health Care Campus

Differential Lung Ventilation vs. CPAP During One Lung Ventilation for Video Assisted Lung Surgery

In this study we compared the efficacy of continuous positive airway pressure (CPAP) to differential lung ventilation, in terms of patient's oxygenation, during video assisted thoracoscopic lung resection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: One Lung Ventilation (OLV) is the technique used during lung resection surgery in order to facilitate optimal surgical conditions. OLV may result in hypoxemia due to the shunt created. Several techniques are used to overcome the hypoxemia, one of which is continuous positive airway pressure (CPAP) to the non-dependent lung. Another technique is ventilating the non-dependent lung with a minimal volume, thus creating differential lung ventilation (DLV). In this study we compared the efficacy of CPAP to DLV during video assisted thoracoscopic lung resection.

Patients and Method: This is a prospective study of 30 adult patients undergoing elective video assisted thoracoscopic lung lobectomy. Each patient was ventilated in four modes: two lung ventilation, OLV, OLV+CPAP and OLV+DLV. Fifteen patients were ventilated with CPAP first and DLV next, and the other 15 were ventilated with DLV first and then CPAP. Five minutes separated each mode, during which the non-dependent lung was open to room air. We measured the patient's arterial blood gas during each mode of ventilation. The surgeons, who were blinded to the ventilation technique, were asked to assess the surgical conditions at each stage.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patients diagnised with lung cancer
  2. Scheduled to have thoracoscopic lung lobectomy -

Exclusion Criteria:

  1. Pregnancy
  2. ASA>=4
  3. Difficult intubation -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cpap first, differential ventilation later
Device: cpap
application of cpap to the non-dependent lung, during one lung ventilation
Active Comparator: differential ventilation first, cpap late
Device: cpap
application of cpap to the non-dependent lung, during one lung ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
arterial blood oxygenation
Time Frame: intraoperative
PaO2
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interference with surgical field exposure
Time Frame: intraoperative
interference
intraoperative
airway pressure in the dependent lung during one lung ventilation
Time Frame: intraoperative
airway pressure
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

May 26, 2018

First Submitted That Met QC Criteria

June 9, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 9, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RMB-0032-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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