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The Cyclocapnic Method for Measurement of Chemosensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01049256
First received: January 13, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

We aim to test our method for measuring chemosensitivity (the ventilatory response to a change in carbon dioxide), which uses sinusoidal carbon dioxide stimuli.

Hypotheses:

  • Carbon dioxide sensitivity is dependent on the cycle time over which we administer the gas (frequency).
  • Chemoreflex gain decreases as deadspace increases.

Condition Intervention Phase
Periodic Breathing
Heart Failure
 Other: carbon dioxide
 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Developing an Improved Measure of Chemosensitivity for the Study of Periodic Breathing in Heart Failure: the Cyclocapnic Method

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Chemoreflex gain as measured by cyclocapnic method [ Time Frame: every minute ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: January 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: carbon dioxide
    sinusoidal carbon dioxide administration
Detailed Description:

We will apply a new method for the measurement of chemosensitivity (how sensitive a person is to changes in carbon dioxide), which is one of the principle determinants of whether people with heart failure develop abnormal breathing patterns We have shown in a pilot study that administering sinusoidal patterns of inspired carbon dioxide produces similar sinusoidal responses in ventilation. We aim to test our method for measuring chemosensitivity, which uses sinusoidal carbon dioxide stimuli (similar to those that drive the oscillations in ventilation found in periodic breathing). We aim to show that how the cycle time of carbon dioxide administered affects the resulting ventilatory oscillations and therefore that when measuring the chemoreflex clinically, it is important to deliver carbon dioxide stimuli that replicate the cycle time of oscillations in carbon dioxide seen in periodic breathing (typically approximately one minute).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Heart failure subjects with stable cardiorespiratory control to be recruited from our institution's specialist heart failure clinic.
  • Normal healthy volunteers, with normal systolic function.

Exclusion Criteria:

  • We will exclude patients with chronic respiratory disease (every patient will have formal lung function testing on entrance into the study) or unstable coronary artery disease (myocardial infarction or unstable angina within the past 3 months).
  • In addition any subjects receiving treatment with morphine and derivatives, theophylline, oxygen, benzodiazepines or acetazolamide will be excluded as these affect chemosensitivity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049256

Contacts
Contact: Darrel P Francis, MD +44 207 594 1093 darrel.francis@imperial.ac.uk

Locations
United Kingdom
St Mary's Hospital Recruiting
London, United Kingdom, W2 1LA
Contact: Resham Baruah, MB BS     020 75941027     resham.baruah@imperial.ac.uk    
Contact: Darrel P Francis, MD     +44 207 594 1093     darrel.francis@imperial.ac.uk    
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Darrel P Francis, MD Imperial College London
  More Information

No publications provided

Responsible Party: Darrel Francis, Imperial College
ClinicalTrials.gov Identifier: NCT01049256     History of Changes
Other Study ID Numbers: 07/H0712/129
Study First Received: January 13, 2010
Last Updated: January 13, 2010
Health Authority: UK: National research ethics committee

Keywords provided by Imperial College London:
Periodic breathing
Heart Failure
Chemoreflex
Chemosensitivity

Additional relevant MeSH terms:
Respiratory Aspiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013