Use Of Capnography As Surrogate Measure Of PC02 In Medica... | NCT00744614

Studies
Use Of Capnography As Surrogate Measure Of PC02 In Medical Intensive Care Unit (ICU) Patients

NCT00744614

Sponsor

Lahey Clinic

Status

Terminated

Last Update Posted

Oct 21, 2010Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Asthma
Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease

Interventions

Capnography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Principal Investigator (central contact) has left the organization and requests the study be terminated

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Oct 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Aug 29, 2008

First Submission Date that Met QC Criteria

Aug 29, 2008

First Posted Date

Sep 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2010

Last Update Posted Date

Oct 21, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Medical Intensive care unit patients with asthma, COPD, ILD or coronary disease who are at risk of intubation	Procedure: Capnography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capnography	Procedure	A technique for monitoring the concentration or partial pressure of CO2 levels in respiratory gases	1

Measure	Description	Time Frame
PCO2 level		6 months

Measure	Description	Time Frame
Time to intubation		6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MICU patients who are at risk of intubation and who have a history of asthma, COPD, ILD or coronary disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David R. Riker, M.D.	Lahey Clinic, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lahey Clinic, Inc.		Burlington	Massachusetts	01805	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18339783	Background	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.

ID	Term
D001249	Asthma
D029424	Pulmonary Disease, Chronic Obstructive
D017563	Lung Diseases, Interstitial

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases