Capnography Data Collection From Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

The Capnography Library: Data Collection From Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359176
• Other study ID #: D0006376C
• Status: Completed
• Phase: N/A
• First received: May 16, 2011
• Last updated: April 24, 2016
• Start date: May 2010
• Est. completion date: January 2015

Study information

• Verified date: May 2010
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Capnography is the non-invasive monitoring of the concentration or partial pressure of carbon dioxide (CO2) in the expired respiratory gases; it is thus a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. The capnogram is a direct monitor of the inhaled and exhaled concentration or partial pressure of CO2, and an indirect monitor of the CO2 partial pressure in the arterial blood. The purpose of this study is to create a waveform library by collecting CO2 waveform data from healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Consent to participate in the trial by volunteer themself or by their legal guardian

Exclusion Criteria:

• Any individual who does not consent themselves or their legal guardian does not grant consent to participate in the trial

• A medical history of heart disease, lung disease, smoking, hypertension, pregnancy, diabetes or any other illness that excludes the participant from enrolling in the trial in the opinion of the PI

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To gather data received from monitoring healthy participants as reference for the creation of a capnography waveform library.	Participants will put on the capnography monitoring device (a simple tube with prongs that fit in the nostrils, similar in design to the oxygen delivering device "nasal cannula") and this device will be hooked up to a computer. The participants will be asked to do very simple activities, such as sit, stand, eat and drink. The changes in their CO2 waveforms during these activities will be recorded in order to build a library of reference waveforms.	One hour	No