- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03567759
Transpulmonary Pressure in One Lung Ventilation and Open Pneumothorax
June 13, 2018 updated by: Dr. Amit Lehavi MD FANZCA, Rambam Health Care Campus
Effect 0ne Lung Ventilation and Open Pneumothorax on Respiratory Mechanics and Transpulmonary Pressure
Esophageal Pressure During one lung ventilation
Study Overview
Status
Completed
Conditions
Detailed Description
Esophageal pressure comparison during positive pressure ventilation, one lung ventilation, lateral position and open pneumothorax
Study Type
Observational
Enrollment (Actual)
20
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
-
-
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Haifa, Israel
- Rambam Medical Center
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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
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients of age 18-85 years scheduled for VATS requiring one lung ventilation
Description
Inclusion Criteria:
- patients scheduled for VATS requiring one lung ventilation
- Body mass index below 35 kg/m^2
Exclusion Criteria:
- esophageal pathology preventing insertion of orogatric tube
- scoliosys
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in esophageal pressure
Time Frame: from tracheal intubation untill fiveminutes after induction of open pneumothorax
|
esophageal pressure in supine and lateral positions, and following one lung ventilation and open pneumothorax
|
from tracheal intubation untill fiveminutes after induction of open pneumothorax
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amit Lehavi, MD, Rambam Health Care Campus
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)
March 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
June 13, 2018
First Submitted That Met QC Criteria
June 13, 2018
First Posted (Actual)
June 26, 2018
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 13, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMB 15-0262
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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