Clinical Respiratory Evaluation Using Spectroscopy Trial (CREST)

This study has been withdrawn prior to enrollment.
(Not started and now discontinued)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01321411
First received: March 21, 2011
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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 Intervention
Respiratory Muscle Blood Flow
Other: Near Infrared Spectroscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Respiratory Evaluation Using Spectroscopy Trial

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Measure and demonstrate the relationship between RMBF and WOB [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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:
  • Demonstrate differences in RMBF-WOB between 2 cohorts [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

    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.



Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321411

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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01321411     History of Changes
Other Study ID Numbers: H10-03356
Study First Received: March 21, 2011
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on August 28, 2014