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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in respiratory rate from baseline to the period 10 seconds after the breath prompt every 10 minutes for approximately the first 24 hours after surgery during the patient's stay

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I had surgery that required me to stay in the hospital for at least one day.

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I will have surgery soon that will cause a lot of pain and need strong painkillers afterwards.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in respiratory rate from baseline to the period 10 seconds after the breath prompt every 10 minutes for approximately the first 24 hours after surgery during the patient's stay

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in respiratory rate from baseline to the period 10 seconds after the breath prompt every 10 minutes for approximately the first 24 hours after surgery during the patient's stay

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in respiratory rate from baseline to the period 10 seconds after the breath prompt every 10 minutes for approximately the first 24 hours after surgery during the patient's stay for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Breath promoting success rate

Oxygen saturation measured by pulse oximetry (SpO2)

Secondary outcome measures

End-tidal CO2 (etCO2)

respiratory rate

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,778,590 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical investigation now recruiting participants?

"According to clinicaltrials.gov, this trial which was initially posted on October 1st 2017 and last updated December 5th 2022 is no longer recruiting patients. But there are 127 other medical studies searching for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Detecting Post-surgical Respiratory Compromise and Prompting Patients to Self-rescue: An Early Feasibility Study

Ken B. Johnson 2017. "Detecting Post-surgical Respiratory Compromise and Prompting Patients to Self-rescue: An Early Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02962557.