Positive Pressure and Gravity Affect Volumetric Capnography

February 21, 2019 updated by: Hospital Privado de Comunidad de Mar del Plata

The Effect of Positive Pressure and Body Position on Volumetric Capnography Assessed by Electrical Impedance Tomography

Volumetric capnography is an interesting and non-invasive tool for monitoring ventilation in mechanically ventilated patients. The aim of this study was to test the effect of positive pressure ventilation and different body positions on volumetric capnograms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this interventional study awake and healthy volunteers will be submitted to spontaneous, pressure support and control pressure ventilation using a tight nasal mask. Volumetric capnography and electrical impedance tomography (EIT) will be continuously recorded during the protocol. Different body positions were randomly tested. Analysis of global and regional distribution of ventilation using EIT will be matched with changes observed in volumetric capnography-derived parameters.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

  • Argentina
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Hospital Privado de Comunidad

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

28 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • American Society Anesthesia physical status I.
  • Age between 25-39 years old,
  • Body mass index between 23-28 kg/m2,
  • Non-smokers.

Exclusion Criteria:

  • Presence of pulmonary or cardiac diseases.
  • Abnormal spirometry.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: non-invasive ventilation
Non-invasive positive pressure at different body positions: sitting - supine - prone - right lateral and left lateral.
Other: body positions
positive pressure ventilation at different body positions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation.
Time Frame: 4 hours
The volunteers are breathing spontaneously with and without positive pressure support. Capnographic parameters were registered at each studied condition.
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.
Time Frame: 4 hours
The volunteers are breathing spontaneously with and without positive pressure support. Electrical impedance images were taken at each studied condition.
4 hours

Collaborators and Investigators

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

Sponsor

Hospital Privado de Comunidad de Mar del Plata

Investigators

  • Principal Investigator: Gerardo H Tusman, MD, Hospital Privado de Comunidad

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.

General Publications

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)

February 1, 2016

Primary Completion (Actual)

February 21, 2019

Study Completion (Actual)

February 21, 2019

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04112014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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