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Behavioural Intervention

Respiratory Self-Rescue Intervention for Anesthesia

N/A
Waitlist Available
Led By Ken B Johnson, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who undergo surgical procedures associated with a post operative hospital stay of at least 24 hours
Patients who will undergo surgical procedures associated with significant post operative pain and require opioid analgesics to manage pain. Sample procedures include major extremity surgery, spine surgery, abdominal surgery, and chest surgery that require a post operative in patient hospital stay
Must not have
Patients who are discharged home on the day of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trialwill explore using standard patient monitors & a recorded nurse's voice to prompt patients to breathe. Monitors include pulse oximeter, capnometer & nasal cannula. Used to detect ventilatory depression & sleep apnea.

Who is the study for?
This trial is for patients who will stay in the hospital at least 24 hours after surgery, including those with known or high-risk obstructive sleep apnea (OSA), and nurses caring for these patients. It's not for day-surgery patients, pregnant women, prisoners, or those unable to consent.
What is being tested?
The study tests if a nurse's recorded voice prompt from a device can encourage post-surgical patients to breathe when they show signs of breathing trouble. This works alongside traditional monitor alarms and uses standard patient monitors.
What are the potential side effects?
There may be minimal side effects as this intervention involves non-invasive monitoring and verbal prompts rather than medication. However, there could be discomfort due to wearing the nasal cannula sensor.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had surgery that required me to stay in the hospital for at least one day.
Select...
I will have surgery soon that will cause a lot of pain and need strong painkillers afterwards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I went home the same day as my surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
The experimental group will receive playback of recorded verbal prompts to breathe with an optional shoulder shake.
Group II: ControlActive Control1 Intervention
The control group will receive no prompts by the recorded voice.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,080 Total Patients Enrolled
Ken B Johnson, MDPrincipal InvestigatorUniversity of Utah

Media Library

NM3 (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT02962557 — N/A
Anesthesia Research Study Groups: Control, Experimental
Anesthesia Clinical Trial 2023: NM3 Highlights & Side Effects. Trial Name: NCT02962557 — N/A
NM3 (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02962557 — N/A
~0 spots leftby Jan 2025
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