Differential Lung Ventilation vs. CPAP

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Completed

CT.gov ID

NCT03563612

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
One Lung Ventilation Continuous Positive Airway Pressure Differential Lung Ventilation	Device: cpap	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

prospective randomized controlled crossover studyprospective randomized controlled crossover study

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Sep 30, 2017

Actual Study Completion Date :

Sep 30, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

arterial blood oxygenation [intraoperative]
PaO2

Secondary Outcome Measures

interference with surgical field exposure [intraoperative]
interference
airway pressure in the dependent lung during one lung ventilation [intraoperative]
airway pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
ASA>=4
Difficult intubation -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Health Care Campus	Haifa		Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Michal Barak, Senior Anesthesiologist, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT03563612

Other Study ID Numbers:

RMB-0032-16

First Posted:

Jun 20, 2018

Last Update Posted:

Jun 20, 2018

Last Verified:

Jun 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Michal Barak, Senior Anesthesiologist, Rambam Health Care Campus

one lung ventilation

continuous positive airway pressure

differential lung ventilation

Study Results

No Results Posted as of Jun 20, 2018