Back to resultsPositive Pressure and Gravity Affect Volumetric Capnography
Primary Purpose
Hypoventilation
Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
body positions
Sponsored by
About this trial
This is an interventional other trial for Hypoventilation focused on measuring volumetric capnography, gravity, mechanical ventilation, EIT
Eligibility Criteria
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.
Sites / Locations
- Hospital Privado de Comunidad
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-invasive ventilation
Arm Description
Non-invasive positive pressure at different body positions: sitting - supine - prone - right lateral and left lateral.
Outcomes
Primary Outcome Measures
Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation.
The volunteers are breathing spontaneously with and without positive pressure support. Capnographic parameters were registered at each studied condition.
Secondary Outcome Measures
Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.
The volunteers are breathing spontaneously with and without positive pressure support. Electrical impedance images were taken at each studied condition.
Full Information
NCT ID
NCT03853057
First Posted
March 3, 2015
Last Updated
February 21, 2019
Sponsor
Hospital Privado de Comunidad de Mar del Plata
1. Study Identification
Unique Protocol Identification Number
NCT03853057
Brief Title
Positive Pressure and Gravity Affect Volumetric Capnography
Official Title
The Effect of Positive Pressure and Body Position on Volumetric Capnography Assessed by Electrical Impedance Tomography
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
February 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Privado de Comunidad de Mar del Plata
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoventilation
Keywords
volumetric capnography, gravity, mechanical ventilation, EIT
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-invasive ventilation
Arm Type
Experimental
Arm Description
Non-invasive positive pressure at different body positions: sitting - supine - prone - right lateral and left lateral.
Intervention Type
Other
Intervention Name(s)
body positions
Intervention Description
positive pressure ventilation at different body positions
Primary Outcome Measure Information:
Title
Analysis of the changes in volumetric capnographic parameters with changes in body positioning and positive pressure ventilation.
Description
The volunteers are breathing spontaneously with and without positive pressure support. Capnographic parameters were registered at each studied condition.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.
Description
The volunteers are breathing spontaneously with and without positive pressure support. Electrical impedance images were taken at each studied condition.
Time Frame
4 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo H Tusman, MD
Organizational Affiliation
Hospital Privado de Comunidad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Privado de Comunidad
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
19186406
Citation
Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.
Results Reference
background
PubMed Identifier
19517259
Citation
Tusman G, Scandurra A, Bohm SH, Suarez-Sipmann F, Clara F. Model fitting of volumetric capnograms improves calculations of airway dead space and slope of phase III. J Clin Monit Comput. 2009 Aug;23(4):197-206. doi: 10.1007/s10877-009-9182-z. Epub 2009 Jun 11.
Results Reference
background
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Positive Pressure and Gravity Affect Volumetric Capnography
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