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
  Purpose

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.


Condition
Healthy Volunteers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Capnography Library: Data Collection From Healthy Participants

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: May 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy volunteers

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult and pediatric healthy volunteers

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359176

Contacts
Contact: Sharon Einav, MD 972-2-666-6664 einav_s@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Sharon Einav, MD    972-2-666-6664    einav_s@szmc.org.il   
Principal Investigator: Sharon Einav, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Sharon Einav, MD Shaare Zedek Medical Centre
  More Information

No publications provided

Responsible Party: Dr. Iris Shalev Yaffe, R&D Clinical Research Manager, Oridion Medical 1987 Ltd
ClinicalTrials.gov Identifier: NCT01359176     History of Changes
Other Study ID Numbers: D0006376C
Study First Received: May 16, 2011
Last Updated: May 23, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on October 22, 2014