Differential Lung Ventilation vs. CPAP

• ClinicalTrials.gov Identifier: NCT03563612
• Recruitment Status: Completed
• First Posted: June 20, 2018
• Last Update Posted: June 20, 2018
• Sponsor: Rambam Health Care Campus
• Information provided by (Responsible Party): Dr Michal Barak, Rambam Health Care Campus

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	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: prospective 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: April 1, 2017
• Actual Primary Completion Date: September 30, 2017
• Actual Study Completion Date: September 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

Outcome Measures

Primary Outcome Measures :

1. arterial blood oxygenation [ Time Frame: intraoperative ]
   PaO2

Secondary Outcome Measures :

1. interference with surgical field exposure [ Time Frame: intraoperative ]
   interference
2. airway pressure in the dependent lung during one lung ventilation [ Time Frame: intraoperative ]
   airway pressure

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 -

Contacts and Locations

Locations

Israel

Rambam Health Care Campus

Haifa, Israel

Sponsors and Collaborators

Rambam Health Care Campus

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kremer R, Aboud W, Haberfeld O, Armali M, Barak M. Differential lung ventilation for increased oxygenation during one lung ventilation for video assisted lung surgery. J Cardiothorac Surg. 2019 May 6;14(1):89. doi: 10.1186/s13019-019-0910-2.

• Responsible Party: Dr Michal Barak, Senior Anesthesiologist, Rambam Health Care Campus
• ClinicalTrials.gov Identifier: NCT03563612
• Other Study ID Numbers: RMB-0032-16
• First Posted: June 20, 2018
• Last Update Posted: June 20, 2018
• Last Verified: June 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Michal Barak, Rambam Health Care Campus:

one lung ventilation; continuous positive airway pressure; differential lung ventilation