Healthy VolunteersNCT01359176
Capnography Data Collection From Healthy Participants
An observational study of Healthy Volunteers, run by Shaare Zedek Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 160 participants
- Where
- 1 siteIsrael
- Study dates
- May 2010to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult and pediatric healthy volunteers
Who may be able to join
- Consent to participate in the trial by volunteer themself or by their legal guardian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Einav, MD, Principal investigator, Shaare Zedek Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359176
- Sponsor's protocol ID
- D0006376C
- Status last verified
- May 2010
- First submitted
- 16 May 2011
- Last updated
- 26 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Capnography Library: Data Collection From Healthy Participants
- ClinicalTrials.gov ID
- NCT01359176
- Acronym / sponsor ID
- D0006376C
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric healthy volunteers
Key inclusion criteria (1 listed)
- Consent to participate in the trial by volunteer themself or by their legal guardian
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To gather data received from monitoring healthy participants as reference for the creation of a capnography waveform library.
Time frame: One hour
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Einav, MD principal investigator
Shaare Zedek Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.