Respiratory Self-Rescue Intervention for Anesthesia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Opioid analgesics

Disqualifiers: Pregnancy, Prisoners, Legal representative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve patients' breathing after surgery. Standard medical monitors detect when a patient isn't breathing well and play a nurse's voice that calls the patient by name to remind them to breathe. The trial focuses on patients who stay in the hospital for at least 24 hours after surgery and may have sleep apnea or require strong pain medication like opioids. Participants in one group will hear the voice prompts, while the control group will not. The trial aims to determine if the voice prompts, part of the NM3 intervention, can enhance breathing without relying solely on traditional alarms.

As an unphased trial, this study provides patients an opportunity to contribute to innovative research that could improve post-surgery care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the study coordinators or your doctor for guidance.

What prior data suggests that this intervention is safe for patients?

Research has shown that the NM3 monitoring system used in this study is generally safe. It has been applied in various medical settings, including with newborns, without major safety issues. The device includes common monitors, such as a pulse oximeter, which checks blood oxygen levels and is widely used and well-tolerated.

No reports have linked problems directly to the NM3 system in the available studies. This suggests that the monitoring tools and methods, including the voice prompts used in this trial, are likely safe for participants. However, as the trial is still in its early stages, researchers will continue to monitor safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel method for improving patient safety during anesthesia. Unlike traditional approaches that rely on monitoring equipment and medical staff intervention, this technique uses recorded verbal prompts and physical cues, like a shoulder shake, to encourage patients to breathe on their own. This innovative approach could enhance patient autonomy and potentially reduce the need for additional medical interventions during anesthesia, offering a fresh perspective on managing respiratory challenges in surgical settings.

What evidence suggests that this intervention is effective for detecting ventilatory depression during anesthesia?

Research has shown that audio prompts reminding patients to breathe can help prevent breathing problems during anesthesia. In this trial, the experimental group will hear recorded verbal prompts to breathe, with an optional shoulder shake, to maintain better breathing patterns and reduce the risk of breathing issues. Standard monitors, similar to those used for sleep apnea, detect when a patient might not be breathing well. Then, a recorded voice gently reminds them to take a breath. This simple reminder aims to make anesthesia safer by encouraging regular breathing without more invasive methods. Meanwhile, the control group will not receive prompts from the recorded voice. ^{6 7 8 9 10}

Who Is on the Research Team?

Ken B Johnson, MD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

PACU nurses who are in charge of caring for consented patients

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

I have or might have sleep apnea based on a test or high STOP-Bang score.

Exclusion Criteria

Vulnerable populations including pregnant women, prisoners, and people requiring legally authorized representative for consent

I went home the same day as my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are monitored for ventilatory depression and receive recorded verbal prompts to breathe during the first 24 hours post-surgery

24 hours

Continuous monitoring in PACU and hospital floor

Follow-up

Participants are monitored for safety and effectiveness after the initial 24-hour monitoring period

1 week

What Are the Treatments Tested in This Trial?

Interventions

• NM3

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

The experimental group will receive playback of recorded verbal prompts to breathe with an optional shoulder shake.

Group II: Control Active Control 1 Intervention

The control group will receive no prompts by the recorded voice.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

A review of 7827 safety reports from 2015 to 2020 revealed that only 67 (0.85%) were related to perioperative airway management, indicating that while these incidents are relatively rare, they can still pose significant risks to patients.

The most common adverse event was 'Intubation Injury,' accounting for 35.8% of airway management incidents, with the majority of events causing temporary or minor harm, highlighting the need for improved training and resources to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. Osgood, KB., Krishnan, S., Wheeler, KK., et al.[2022]

From 2010 to 2015, a review of 2544 adverse events in pediatric anesthesia revealed that the most common issues were cardiac arrests (31.6%), respiratory complications (29.2%), and medication errors (16.9%).

A striking 85% of anesthesia-related serious adverse events were considered preventable, highlighting the need for innovations focused on reducing medication errors to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes from wake up safe, the pediatric anesthesia quality improvement initiative. Haché, M., Sun, LS., Gadi, G., et al.[2021]

Citations

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Analysis of the Anesthesia Closed Claims database suggests that adverse respiratory events continue to be the main cause of morbidity and ...

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The study group exhibited a significant increase in respiratory system compliance (P < 0.05) and improved intraoperative oxygenation (P < 0.05).

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