NCT00744614

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

2.9 years

First QC Date

August 29, 2008

Last Update Submit

October 19, 2010

Conditions

AsthmaChronic Obstructive Pulmonary DiseaseInterstitial Lung Disease

Keywords

PC02Respiratory RateArterial blood gasIntubationCapnography

Outcome Measures

Primary Outcomes (1)

  • PCO2 level

    6 months

Secondary Outcomes (1)

  • Time to intubation

    6 months

Study Arms (1)

1

Medical Intensive care unit patients with asthma, COPD, ILD or coronary disease who are at risk of intubation

Procedure: Capnography

Interventions

CapnographyPROCEDURE

A technique for monitoring the concentration or partial pressure of CO2 levels in respiratory gases

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Medical Intensive Care Patients
  • Not intubated
  • Age 18 or older
  • History of any one of the following: asthma, COPD, ILD, or coronary disease

You may not qualify if:

  • Sepsis
  • Life expectancy less than 1 month
  • Requiring BIPAP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Related Publications (1)

  • 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.

    PMID: 18339783BACKGROUND

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David R. Riker, M.D.

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

November 1, 2007

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 21, 2010

Record last verified: 2010-10

Locations

US(1)