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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric healthy volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Sharon Einav, MD, Shaare Zedek Medical Centre

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 24, 2016
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: D0006376C