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

NCT02744599 | Completed

• 2 other identifiers: IRB_00056695R43NR015955
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Feasibility trial

Outcome Measures

Primary Outcomes (1)

• Breath prompting successful rate

  Change in respiratory rate from baseline to the period 10 seconds after the breath prompt

Study Arms (2)

Device prompting

EXPERIMENTAL

Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany

Control

NO INTERVENTION

Patients receive standard of care

Interventions

Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany DEVICE

Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany

Device prompting

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Nursing Research (NINR): collaborator

Related Publications (3)

• Farney RJ, Johnson KB, Ermer SC, Orr JA, Egan TD, Morris AH, Brewer LM. Quantified Ataxic Breathing Can Detect Opioid-Induced Respiratory Depression Earlier in Normal Volunteers Infused with Remifentanil. Anesth Analg. 2025 Sep 1;141(3):507-515. doi: 10.1213/ANE.0000000000007124. Epub 2024 Aug 23.

  PMID: 39178322 DERIVED

• 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.

  PMID: 32287122 DERIVED

• 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.

  PMID: 30234539 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 20, 2016
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share