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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will explore the feasibility of an idea to use standard, FDA-approved patient monitors to detect ventilatory depression and then play a recorded nurse's voice to prompt patients by name to breathe. The voice prompt will occur in addition to when the traditional alarms are sounded by the monitors. The study device consists of commercially available physiologic monitors, a speaker, and a laptop computer. The physiologic monitors include a pulse oximeter with a motion sensor, capnometer, and nasal airway pressure sensor (built into a nasal cannula). Nasal pressure is a commonly used clinical monitor for sleep apnea detection during polysomnography testing in sleep labs.

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 data supports the effectiveness of the treatment NM3 in the Respiratory Self-Rescue Intervention for Anesthesia trial?

The research highlights the importance of effective airway management and the use of emergency manuals to improve patient safety during anesthesia. These findings suggest that structured interventions and training can enhance the management of respiratory events, which may indirectly support the effectiveness of NM3 in improving outcomes during anesthesia. ^{1 2 3 4 5}

Is the Respiratory Self-Rescue Intervention for Anesthesia generally safe for humans?

The safety data for anesthesia-related procedures, including airway management, shows that while adverse events can occur, they are often minor or temporary. Safety measures like ongoing education and improved equipment can help reduce risks. ^{1 6 7 8 9}

How is the NM3 treatment for anesthesia-related respiratory issues different from other treatments?

The NM3 treatment, as part of the Respiratory Self-Rescue Intervention for Anesthesia, may involve novel approaches like the Lubo Airway Collar, which provides an automated jaw thrust to alleviate upper airway obstruction, making it unique compared to traditional manual methods used in anesthesia-related respiratory issues. ^{10 11 12 13 14}

Research Team

Ken B Johnson, MD

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Debriefing immediately after intubation in a children's emergency department is feasible and contributes to measurable improvements in patient safety. [2021]

2. England pubmed.ncbi.nlm.nih.gov

First pass success of tracheal intubation using the C-MAC PM videolaryngoscope as first-line device in prehospital cardiac arrest compared with other emergencies: An observational study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Free Emergency Manual Books Improve Actual Clinical Use During Crisis in China. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Pre-hospital anaesthesia: the same but different. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

It's Not Over Till It's Over: A Prospective Cohort Study and Analysis of "Anesthesia Stat!" Emergency Calls in the Pediatric Post-Anesthesia Care Unit (PACU). [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Preventing errors with neuromuscular blocking agents. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Airway management in the operating room setting: An analysis of reported safety events. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Patterns in medication incidents: A 10-yr experience of a cross-national anaesthesia incident reporting system. [2020]

9. France pubmed.ncbi.nlm.nih.gov

Outcomes from wake up safe, the pediatric anesthesia quality improvement initiative. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Lubo Airway Collar as a Rescue in Magnetic Resonance Imaging. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A persistent 'can't intubate, can't oxygenate' crisis despite rocuronium reversal with sugammadex. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Rapid Sequence Airway (RSA)--a novel approach to prehospital airway management. [2007]

13. England pubmed.ncbi.nlm.nih.gov

Oxygenation laryngoscope vs. nasal standard and nasal high flow oxygenation in a technical simulation of apnoeic oxygenation. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Drawover anesthesia. A review of equipment, capabilities, and utility under austere conditions. [2013]