AsthmaNCT00744614
Use Of Capnography As Surrogate Measure Of PC02 In Medical Intensive Care Unit (ICU) Patients
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Lahey Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of Capnography (Continuous recording of the carbon dioxide content of expired air)as an alternative test to measure PC02 levels in patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or coronary disease who are at risk of intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- What is being tested?
- Capnography
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Oct 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MICU patients who are at risk of intubation and who have a history of asthma, COPD, ILD or coronary disease.
Who may be able to join
- Medical Intensive Care Patients
- Not intubated
- Age 18 or older
- History of any one of the following: asthma, COPD, ILD, or coronary disease
Who cannot join
- Sepsis
- Life expectancy less than 1 month
- Requiring BIPAP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use Of Capnography As Surrogate Measure Of PC02 In Medical ICU Patients
The purpose of this study is to evaluate the use of Capnography (Continuous recording of the carbon dioxide content of expired air)as an alternative test to measure PC02 levels in patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or coronary disease who are at risk of intubation.
Read the detailed description
This is a prospective study to evaluate the usefulness of capnography as a non-invasive, accurate method of measuring of PC02 levels in medical intensive care unit patients with asthma, COPD, ILD, or coronary disease who are at risk of intubation.
- Being tested
- Capnography
- Keywords
- PC02, Respiratory Rate, Arterial blood gas, Intubation, Capnography
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapnographyProcedure or surgery
A technique for monitoring the concentration or partial pressure of CO2 levels in respiratory gases
| Study group | Role | What they receive |
|---|---|---|
| 1 | Medical Intensive care unit patients with asthma, COPD, ILD or coronary disease who are at risk of intubation Receives: Procedure: Capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCO2 level
Measured: 6 months
Secondary outcomes (1)
Time to intubation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Principal Investigator (central contact) has left the organization and requests the study be terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Investigators
- David R. Riker, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744614
- Sponsor's protocol ID
- 2007-115
- Status last verified
- Oct 2010
- First submitted
- 29 Aug 2008
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Torok SS, Leuppi JD, Baty F, Tamm M, Chhajed PN. Combined oximetry-cutaneous capnography in patients assessed for long-term oxygen therapy. Chest. 2008 Jun;133(6):1421-1425. doi: 10.1378/chest.07-0960. Epub 2008 Mar 13.
PubMed 18339783
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Capnography As Surrogate Measure Of PC02 In Medical ICU Patients
- ClinicalTrials.gov ID
- NCT00744614
- Acronym / sponsor ID
- 2007-115
- Keywords
- PC02, Respiratory Rate, Arterial blood gas, Intubation, Capnography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator (central contact) has left the organization and requests the study be terminated
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 1 Sep 2008 (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.
The purpose of this study is to evaluate the use of Capnography (Continuous recording of the carbon dioxide content of expired air)as an alternative test to measure PC02 levels in patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or coronary disease who are at risk of intubation.
Detailed description
This is a prospective study to evaluate the usefulness of capnography as a non-invasive, accurate method of measuring of PC02 levels in medical intensive care unit patients with asthma, COPD, ILD, or coronary disease who are at risk of intubation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: CapnographyMedical Intensive care unit patients with asthma, COPD, ILD or coronary disease who are at risk of intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MICU patients who are at risk of intubation and who have a history of asthma, COPD, ILD or coronary disease.
Key inclusion criteria (4 listed)
- Medical Intensive Care Patients
- Not intubated
- Age 18 or older
- History of any one of the following: asthma, COPD, ILD, or coronary disease
Key exclusion criteria (3 listed)
- Sepsis
- Life expectancy less than 1 month
- Requiring BIPAP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapnographyA technique for monitoring the concentration or partial pressure of CO2 levels in respiratory gases | Procedure or surgery | 1 |
Primary outcome
PCO2 level
Time frame: 6 months
1 secondary outcome
Time to intubation
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Principal Investigator (central contact) has left the organization and requests the study be terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
- Background: PubMed 18339783Torok SS, Leuppi JD, Baty F, Tamm M, Chhajed PN. Combined oximetry-cutaneous capnography in patients assessed for long-term oxygen therapy. Chest. 2008 Jun;133(6):1421-1425. doi: 10.1378/chest.07-0960. Epub 2008 Mar 13.
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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.
David R. Riker, M.D. principal investigator
Lahey Clinic, Inc.
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 Asthma and Chronic Obstructive Pulmonary Disease, run by Lahey Clinic at 1 site in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Oct 2010. 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 United States. 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 was stopped early (reason given: Principal Investigator (central contact) has left the organization and requests the study be terminated). Results are not available in the source record.
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?
PCO2 level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00744614, which also lists 1 linked publication.
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 21 Oct 2010.