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

      • Haifa, Israel
        • Rambam Medical Center

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.

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

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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