Clinical Respiratory Evaluation Using Spectroscopy Trial (CREST)
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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 |
- 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).
- 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.
| Estimated Enrollment: | 32 |
| 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 |
Critically Ill and Health Volunteers
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| Contact: William R Henderson, FRCPC | 604-875-5949 | william.henderson@vch.ca |
| Contact: Denise A Foster, RN, CCRP | 604-875-4111 ext 68336 | denise.foster@vch.ca |
| Canada, British Columbia | |
| Vancouver General Hospital | Not yet recruiting |
| Vancouver, British Columbia, Canada, V5Z1M9 | |
| Contact: William R Henderson, FRCPC 604-875-5949 william.henderson@vch.ca | |
| Contact: Denise A Foster, RN, CCRP 604-875-4111 ext 68336 denise.foster@vch.ca | |
| Principal Investigator: William R Henderson, FRCPC | |
| Sub-Investigator: Donald EG Griesdale, FRCPC | |
| Health and Integrative Physiology Laboratory, UBC | Not yet recruiting |
| Vancouver, British Columbia, Canada, V6P 1Z1 | |
| Contact: William R Henderson, FRCPC 604-875-5949 william.henderson@vch.ca | |
| 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: | December 9, 2011 |
| 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 May 16, 2013