Clinical trial NCT02744599: Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
Official title: Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Feasibility trial
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2016-04-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a small trial to test feasibility of an idea for a potential device. The investigators tested the feasibility of prompting a volunteer to breathe when their breathing had slowed down during administration of anesthetic drugs.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesia (ASA) Class I and Class II male and female (non-pregnant/non-lactating) volunteers.
* Normal healthy individual as indicated by medical history and a physical examination.
* At least 18 years of age and less than 55 years of age.
* Negative drug screen.
* Uncomplicated airway anatomy.
* A Body Mass Index between 18 and 32.
* Are fully informed of the risks of entering the study and willingly provide written consent to enter the trial.
* Female subjects of child bearing potential will have a negative urine pregnancy test on the day the study is conducted.

Exclusion Criteria:

* Known or suspected neurological pathologies.
* A history of significant alcohol or drug abuse, a history of allergy to opioids or propofol, or a history of chronic drug requirement or medical illness that is known to alter the pharmacokinetics or pharmacodynamics of remifentanil and propofol.
* Known obstructive sleep apnea.
* Known or suspected hypersensitivity to any compound present in the study.
* Any potential subject suffering from medical problems that, in the judgment of the investigator, presents unacceptable risk to the volunteer are not eligible for enrollment.
* Vulnerable subject groups such as prisoners and the mentally disabled that are traditionally excluded from medical research are also excluded.
* The potential subject has taken any medication within 2 days prior to chosen drug administration, with the exception of oral contraceptives.
* The potential subject is wearing artificial nails.
* A positive urine pregnancy test (females only)
* Female subjects who are currently lactating \& breast-feeding.
* A positive drug-screening test.
* The subject consumed food or fluids within 8 hours prior to start of each chosen drug administration.
* Any medications or alcohol within 2 days prior to start of the chosen drug administration, with the exception of oral contraceptives.

Primary outcomes:
measure: Breath prompting successful rate
timeFrame: Change in respiratory rate from baseline to the period 10 seconds after the breath prompt
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ermer SC, Farney RJ, Johnson KB, Orr JA, Egan TD, Brewer LM. An Automated Algorithm Incorporating Poincare Analysis Can Quantify the Severity of Opioid-Induced Ataxic Breathing. Anesth Analg. 2020 May;130(5):1147-1156. doi: 10.1213/ANE.0000000000004498.
citation: Ermer S, Brewer L, Orr J, Egan TD, Johnson K. Comparison of 7 Different Sensors for Detecting Low Respiratory Rates Using a Single Breath Detection Algorithm in Nonintubated, Sedated Volunteers. Anesth Analg. 2019 Aug;129(2):399-408. doi: 10.1213/ANE.0000000000003793.