NCT03853057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2016

Enrollment Period

3.1 years

First QC Date

March 3, 2015

Last Update Submit

February 21, 2019

Conditions

Keywords

volumetric capnographygravitymechanical ventilationEIT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Electrical impedance images of the distribution of ventilation with changes in body positioning and positive pressure ventilation.

    4 hours

Study Arms (1)

non-invasive ventilation

EXPERIMENTAL

Non-invasive positive pressure at different body positions: sitting - supine - prone - right lateral and left lateral.

Other: body positions

Interventions

positive pressure ventilation at different body positions

non-invasive ventilation

Eligibility Criteria

Age28 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Privado de Comunidad

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Related Publications (2)

  • Costa EL, Lima RG, Amato MB. Electrical impedance tomography. Curr Opin Crit Care. 2009 Feb;15(1):18-24. doi: 10.1097/mcc.0b013e3283220e8c.

    PMID: 19186406BACKGROUND
  • 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.

    PMID: 19517259BACKGROUND

MeSH Terms

Conditions

Hypoventilation

Interventions

Posture

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gerardo H Tusman, MD

    Hospital Privado de Comunidad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2015

First Posted

February 25, 2019

Study Start

February 1, 2016

Primary Completion

February 21, 2019

Study Completion

February 21, 2019

Last Updated

February 25, 2019

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations