HealthyNCT02744599
Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
A study testing Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany in people with Healthy, run by University of Utah.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
- Being tested
- Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany
- Keywords
- Feasibility trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prompting breaths via recorded voice, vibrating massager, and/or muscle tetanyDevice
Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany
| Study group | Role | What they receive |
|---|---|---|
| Device prompting | Experimental | Not described Receives: Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany |
| Control | No intervention | Patients receive standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath prompting successful rate
Measured: Change in respiratory rate from baseline to the period 10 seconds after the breath prompt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Lara Brewer, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744599
- Sponsor's protocol ID
- IRB_00056695
- Other IDs
- R43NR015955
- Status last verified
- Mar 2019
- First submitted
- 7 Apr 2016
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39178322Ermer 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.
PubMed 32287122Ermer 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.
PubMed 30234539
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial for Detecting Drug-induced Respiratory Depression and Prompting for Self-rescue
- ClinicalTrials.gov ID
- NCT02744599
- Acronym / sponsor ID
- IRB_00056695
- Conditions
- Healthy
- Keywords
- Feasibility trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device prompting | Experimental | Device: Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany |
| Control | No intervention | –Patients receive standard of care |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prompting breaths via recorded voice, vibrating massager, and/or muscle tetanyPrompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany | Device | Device prompting |
Primary outcome
Breath prompting successful rate
Time frame: Change in respiratory rate from baseline to the period 10 seconds after the breath prompt
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Derived from this study: PubMed 39178322Farney 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.
- Derived from this study: PubMed 32287122Ermer 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.
- Derived from this study: PubMed 30234539Ermer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany in people with Healthy, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath prompting successful rate (time frame: Change in respiratory rate from baseline to the period 10 seconds after the breath prompt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744599, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.