- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00744614
Use Of Capnography As Surrogate Measure Of PC02 In Medical Intensive Care Unit (ICU) Patients
October 19, 2010 updated by: Lahey Clinic
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.
Study Overview
Status
Terminated
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Burlington, Massachusetts, United States, 01805
- Lahey Clinic, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
MICU patients who are at risk of intubation and who have a history of asthma, COPD, ILD or coronary disease.
Description
Inclusion Criteria:
- Medical Intensive Care Patients
- Not intubated
- Age 18 or older
- History of any one of the following: asthma, COPD, ILD, or coronary disease
Exclusion Criteria:
- Sepsis
- Life expectancy less than 1 month
- Requiring BIPAP
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Medical Intensive care unit patients with asthma, COPD, ILD or coronary disease who are at risk of intubation
|
A technique for monitoring the concentration or partial pressure of CO2 levels in respiratory gases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PCO2 level
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to intubation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David R. Riker, M.D., Lahey Clinic, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
August 29, 2008
First Submitted That Met QC Criteria
August 29, 2008
First Posted (Estimate)
September 1, 2008
Study Record Updates
Last Update Posted (Estimate)
October 21, 2010
Last Update Submitted That Met QC Criteria
October 19, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007-115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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