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Clinical Respiratory Evaluation Using Spectroscopy Trial (CREST)

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ClinicalTrials.gov Identifier: NCT01321411
Recruitment Status : Withdrawn (Not started and now discontinued)
First Posted : March 23, 2011
Last Update Posted : March 6, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
Respiratory muscles (the muscles used to breathe) need more blood (and oxygen) when their workload increases. It is difficult to measure respiratory muscle blood flow (RMBF) without invasive techniques. We will evaluate a new, much less invasive technique to measure RMBF in 2 groups: Healthy Volunteers and Critically Ill patients on breathing machines. The purpose of this study is to determine the accuracy of this new monitoring technique called Near Infrared Spectroscopy Utilizing Indocyanine Green Dye when compared with traditional measurements. The information gained from this study will help us to provide better care to patients with severe lung problems.

Condition or disease Intervention/treatment
Respiratory Muscle Blood Flow Other: Near Infrared Spectroscopy

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Respiratory Evaluation Using Spectroscopy Trial
Study Start Date : February 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2012

Group/Cohort Intervention/treatment
1. ARDS/COPD
Critically ill patients with either ARDS or COPD weaning from mechanical ventilation.
Other: Near Infrared Spectroscopy

Clinical Volunteers:

Study #3 (Abnormal Pulmonary Resistance) subjects recovering from COPD exacerbations will breathe through their ventilator circuit. PAV support will be altered to change the subjects' WOB. WOB and RMBF will be measured during resting breathing, as well as at 75%, 125% and 150% of baseline WOB.

Study #4 (Abnormal Pulmonary Compliance) subjects recovering from ARDS will breathe through their ventilator circuit. PAV support will be altered to change the subjects' WOB. WOB and RMBF will be measured during resting breathing, as well as at 75%, 125% and 150% of baseline WOB.

2. Healthy Volunteers Other: Near Infrared Spectroscopy

Healthy Volunteers:

Study #1 (Abnormal Pulmonary Resistance) subjects will breathe through a Starling resistor simulating abnormal pulmonary resistance. WOB and RMBF will be measured during resting breathing, as well as at 25%, 50% and 75% of MVV.

Study #2 (Abnormal Pulmonary Compliance) subjects will breathe while wearing a chest binder simulating abnormal pulmonary resistance. WOB and RMBF will be measured during resting breathing, as well as at 25%, 50% and 75% of MVV.




Primary Outcome Measures :
  1. Measure and demonstrate the relationship between RMBF and WOB [ Time Frame: 3 hours ]
    To measure and demonstrate the relationship between RMBF and WOB in healthy volunteers simulating abnormal pulmonary resistance and compliance AND in critically ill subjects with abnormal respiratory muscle function (weaning from mechanical ventilation after exacerbations of COPD or ARDS).


Secondary Outcome Measures :
  1. Demonstrate differences in RMBF-WOB between 2 cohorts [ Time Frame: 3 hours ]

    We speculate that the blood flow rates in respiratory muscles for a given WOB will be different in clinical populations that in healthy volunteers.

    Objective: To demonstrate that the RMBF-WOB relationships in clinical populations will be different from that measured in healthy volunteers.




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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Critically Ill and Health Volunteers
Criteria

Inclusion Criteria:

Healthy Volunteers

  • 19 years of age or older
  • Informed Consent Obtained
  • No history of cardiopulmonary disease
  • No history of smoking

Critically Ill

  • 19 years of age or older
  • Informed Consent Obtained
  • Total pulmonary system resistance (as measured through the mechanical ventilator circuit) of 2-8 cmH20/L/second OR Total pulmonary system static compliance (as measured through the mechanical ventilator circuit) of 20-60 ml/cmH20

Exclusion Criteria for all studies:

  • Esophageal lesions or esophageal surgery within the last 6 months
  • Morbid obesity - defined as a Body Mass Index (BMI) > 40
  • Allergy to any of the following: sulpha medications, penicillin, contrast dye, or iodine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321411


Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: William R Henderson, FRCPC University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01321411     History of Changes
Other Study ID Numbers: H10-03356
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: March 6, 2014
Last Verified: March 2014

Keywords provided by University of British Columbia:
Respiratory Muscle Blood Flow
Work of Breathing
Near Infrared Spectroscopy