Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods. (Lungbaro)

January 5, 2018 updated by: Stefan Lundin

Intraoperative Measurement of Lung Elastance and Transpulmonary Pressure Using Two Different Methods

Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations i esophagus pressure divided by the tidal volume. This requires the presence of a esophageal balloon catheter which is cumbersome and costly. In this study values obtained as described above are compared to values obtained with a new method in which a stepwise increase in positive endexpiratory pressure (PEEP) is performed with a size which corresponds to the tidal volume which the patient is ventilated with. These measurements are performed in anesthetized patients prior to major surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

Classically lung elastance and transpulmonary pressure are measured from the difference in tidal variations of airway pressure subtracted by tidal variations in esophageal pressure divided by the tidal volume (Method 1). This requires the presence of a esophageal balloon catheter which is cumbersome and costly.

In this study values obtained as described in Method 1 above are compared to values obtained with a new method in which a PEEP-step is performed with a size which corresponds to the tidal volume which the patient is ventilated with. Measurements using Method 1 and 2 are performed in anesthetized patients prior to major surgery.

Study Type

Observational

Enrollment (Actual)

24

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

      • Gothenburg, Sweden, S-413 45
        • Sahlgrenska University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients which are anesthetized and muscle relaxed and are planned to undergo major surgery

Description

Inclusion Criteria:

  • Patient undergoing major surgery during anesthesia and muscle relaxation

Exclusion Criteria:

  • Patient with chronic obstructive lung disease

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung elastance - transpulmonary pressure
Lung elastance and transpulmonary pressure measured by tidal esophageal pressure variations and by performing a PEEP step
Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of lung elastance
Time Frame: At 1 hour
Comparison of two method for measurements of lung elastance (Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume)
At 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Stefan Lundin, Professor, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

June 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (Estimate)

July 13, 2016

Study Record Updates

Last Update Posted (Actual)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • LUA-74201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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