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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03853057
Other study ID # 04112014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2016
Est. completion date February 21, 2019

Study information

Verified date February 2016
Source Hospital Privado de Comunidad de Mar del Plata
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 21, 2019
Est. primary completion date February 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 28 Years to 39 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
body positions
positive pressure ventilation at different body positions

Locations

Country Name City State
Argentina Hospital Privado de Comunidad Mar del Plata Buenos Aires

Sponsors (1)

Lead Sponsor Collaborator
Hospital Privado de Comunidad de Mar del Plata

Country where clinical trial is conducted

Argentina, 

References & Publications (2)

Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. Review. — View Citation

Tusman G, Scandurra A, Böhm 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 hours
Secondary 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. 4 hours
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