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Capnography Data Collection From Healthy Participants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01359176
First received: May 16, 2011
Last updated: May 23, 2011
Last verified: May 2010
History of Changes

May 16, 2011
May 23, 2011
May 2010
December 2012   (final data collection date for primary outcome measure)
To gather data received from monitoring healthy participants as reference for the creation of a capnography waveform library. [ Time Frame: One hour ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01359176 on ClinicalTrials.gov Archive Site
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Capnography Data Collection From Healthy Participants
The Capnography Library: Data Collection From Healthy Participants

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Adult and pediatric healthy volunteers
Healthy Volunteers
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Healthy volunteers
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
January 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
1 Year and older
Yes
Contact: Sharon Einav, MD 972-2-666-6664 einav_s@szmc.org.il
Israel
 
NCT01359176
D0006376C
No
Dr. Iris Shalev Yaffe, R&D Clinical Research Manager, Oridion Medical 1987 Ltd
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Sharon Einav, MD Shaare Zedek Medical Centre
Shaare Zedek Medical Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP