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

NCT02962557 | Active Not Recruiting FDA Device

• 1 other identifier: 93779
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ventilatory depression

Outcome Measures

Primary Outcomes (2)

• Oxygen saturation measured by pulse oximetry (SpO2)

  Average and median SpO2 will be measured every 10 minutes for approximately the first 24 hours after surgery during the patient's stay

• Breath promoting success rate

  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

Secondary Outcomes (2)

• respiratory rate

  Average and median respiratory rate will be measured every 10 minutes for approximately the first 24 hours after surgery during the patient's stay

• End-tidal CO2 (etCO2)

  Average and median etCO2 will be measured every 10 minutes for approximately the first 24 hours after surgery during the patient's stay

Study Arms (2)

Control

NO INTERVENTION

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

Experimental

EXPERIMENTAL

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

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

Interventions

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

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that meet the following criteria will be invited to participate in this study:
• Patients who undergo surgical procedures associated with a post operative hospital stay of at least 24 hours.
• Patients with known or suspected obstructive sleep apnea (OSA). Known OSA will be defined as a sleep hypopnea study within the last 10 years that is consistent with OSA. Suspected OSA will be defined as a patient with a screening questionnaire (STOP-Bang) score of 5-8 (A score consistent with a high risk of OSA). The STOP-Bang questionnaire is a built in component of the anesthesia preopreative evaluation in EPIC.
• 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.
• Nurses who meet the following criteria will be invited to participate in this study:
• PACU nurses who are in charge of caring for consented patients.

You may not qualify if:

• Patients who are discharged home on the day of surgery.
• Vulnerable populations including pregnant women, prisoners, and people requiring legally authorized representative for consent

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ken B Johnson, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: November 11, 2016
• Study Start: October 1, 2017
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)