A Study to Investigate the Effects of Opioid Exposure on the Ability of the Diaphragm Muscle
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to evaluate opioid dose effects on the ability of the diaphragm muscle to generate higher force behaviors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients who refuse research participation.
Patients who are pregnant.
Patients with known pulmonary pathology (COPD, asthma requiring routine treatment).
Trial design
Design model
Parallel
Treatments tested in this trial
Fentanyl Injection
DrugThree different fentanyl doses (used for sedation) will be evaluated on their effects on shear wave elastography (SWE) and breathing
Treatment groups
69 Participants
are divided into 3 treatment groupsGroup A: Ultrasound Shear Wave Elastography Examination - LowerExperimental treatment 1 intervention
Group B: Ultrasound Shear Wave Elastography Examination - MidExperimental treatment 1 intervention
Group C: Ultrasound Shear Wave Elastography Examination - HigherExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Young's modulus (derived from shear wave speed)
Measured by the ultrasound elastography of the diaphragm muscle reported in KPa
Time frame
Baseline, 10 min post-opioidSponsors and contacts
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Mayo Clinic
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov