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

NCT02962557 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-05

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia

Interventions

DEVICE

NM3, Phillips Medical, Wallingford CT: verbal prompts to breathe with an optional shoulder shake

The device used is the NM3 by Phillips Medical, Wallingford CT. The prompting for breaths will include a recorded voice played at 100 decibels played by a speaker placed within 4 feet of the patient's head. If successful breath response is monitored by the patient monitors but no additional subsequent breaths occur within 20 seconds, the verbal prompt will be repeated for the patient to breathe. If the verbal prompting does not result in a breath detected by the patient monitors, the verbal prompt will be repeated within 20 seconds, optionally accompanied by a shoulder shake from the shoulder massager.

Sponsors & Collaborators

Principal Investigators

  • Ken B Johnson, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2026-01-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02962557 on ClinicalTrials.gov