Back to resultsFeasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany
Sponsored by
About this trial
This is an interventional other trial for Healthy focused on measuring Feasibility trial
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Device prompting
Control
Arm Description
Patients receive standard of care
Outcomes
Primary Outcome Measures
Breath prompting successful rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02744599
First Posted
April 7, 2016
Last Updated
March 13, 2019
Sponsor
University of Utah
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT02744599
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Feasibility trial
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device prompting
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients receive standard of care
Intervention Type
Device
Intervention Name(s)
Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany
Intervention Description
Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany
Primary Outcome Measure Information:
Title
Breath prompting successful rate
Time Frame
Change in respiratory rate from baseline to the period 10 seconds after the breath prompt
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32287122
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.
Results Reference
derived
PubMed Identifier
30234539
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.
Results Reference
derived
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Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
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