Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device prompting	Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany; Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany
NO_INTERVENTION: Control; Patients receive standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Breath prompting successful rate	Change in respiratory rate from baseline to the period 10 seconds after the breath prompt

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute of Nursing Research (NINR)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (ESTIMATE): April 20, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Feasibility trial
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: IRB_00056695; R43NR015955 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No