- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03563612
Differential Lung Ventilation vs. CPAP
Differential Lung Ventilation vs. CPAP During One Lung Ventilation for Video Assisted Lung Surgery
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Rambam Health Care Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients diagnised with lung cancer
- Scheduled to have thoracoscopic lung lobectomy -
Exclusion Criteria:
- Pregnancy
- ASA>=4
- Difficult intubation -
Study Plan
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
|
application of cpap to the non-dependent lung, during one lung ventilation
|
Active Comparator: differential ventilation first, cpap late
|
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RMB-0032-16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on One Lung Ventilation
-
University of EdinburghNHS LothianCompletedOne-Lung VentilationUnited Kingdom
-
Yonsei UniversityCompletedOne Lung VentilationKorea, Republic of
-
Radboud University Medical CenterCompleted
-
Sichuan UniversityWest China HospitalTemporarily not availableOne Lung Ventilation
-
Bezmialem Vakif UniversityNot yet recruitingOne-lung VentilationTurkey
-
Mansoura UniversityRecruitingOne Lung VentilationEgypt
-
Seoul National University HospitalCompleted
-
Dokuz Eylul UniversityCompletedOne Lung VentilationTurkey
-
Joseph D. TobiasCompletedOne-lung Ventilation (OLV)United States
Clinical Trials on cpap
-
State Key Laboratory of Respiratory DiseaseCompletedSleep Apnea, Obstructive | Continuous Positive Airway Pressure | PolysomnographyChina
-
University of ZurichSwiss National Science FoundationCompleted
-
Chinese University of Hong KongCompleted
-
Ulysses Magalang MDTerminatedObstructive Sleep ApneaUnited States
-
The Hospital for Sick ChildrenCompletedObesity | Cardiovascular Disease | Obstructive Sleep Apnea | Sleep DisordersCanada
-
Krishna M. SundarCompleted
-
University Hospital, GrenobleCompleted
-
Fisher and Paykel HealthcareSuburban Lung AssociatesCompletedSleep Apnea, ObstructiveUnited States
-
University Hospital, LilleCompletedSleep Apnea Syndromes | Epilepsies, PartialFrance
-
Ohio State UniversityCompletedHeart Failure | Obstructive Sleep Apnea | Heart Failure, CongestiveUnited States