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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Device: NM3, Phillips Medical, Wallingford CT: verbal prompts to breathe with an optional shoulder shake

Detailed Description

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.

The study will be conducted in patients that are admitted to the hospital following surgery. Patients will be monitored during the first 24 hours after surgery, first in the recovery room (post anesthesia care unit, or PACU) and then on the hospital floor. The study will enroll patients with a high likelihood of experiencing ventilatory depression and/or partial to complete airway obstruction. This patient group includes those with known or suspected obstructive sleep apnea and those with surgeries associated with moderate to severe postoperative pain that require significant opioid administration after surgery. The study will compare effectiveness of prompting patients to breathe to that of routine clinical practice in the PACU and hospital floor. The hypothesis is that when compared to standard monitoring and interventions by clinical staff, the digitized breath prompting will prompt patients to breathe more quickly, which will lead to higher oxygen-hemoglobin saturations and respiratory rates throughout the first 24 hours of a patient's hospital stay following surgery.

For patient safety purposes, the experimental design of this study will implement this device as a shadow monitor. Patients will be instrumented with standard physiologic monitors per routine practice in each hospital location (PACU and floor). There will be no change in how clinical staff interacts with patients (i.e. prompting to breathe, checking vital signs, administering medications, assessing patient well-being, etc.) Clinical staff may disable the device at any time if patient comfort or safety are in question.

This study involves use of already cleared medical devices in which they are used in accordance with the indications in the cleared labeling. What is unique is that output from these monitoring devices will be used to prompt a patient directly by name to breathe. The goal of this study is to test the feasibility of the idea that patients will respond to prompts to breathe by a digitized prompting system. If the concept is successful in patients after surgery, as it was for healthy volunteers in previous testing, future research steps would include designing a device and testing it in a clinical trial on patients on the general floor.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University Of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients that meet the following criteria will be invited to participate in this study:

1. Patients who undergo surgical procedures associated with a post operative hospital stay of at least 24 hours.

2. 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.

   OR

3. 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.

Exclusion Criteria:

1. Patients who are discharged home on the day of surgery.
2. Vulnerable populations including pregnant women, prisoners, and people requiring legally authorized representative for consent
3. There are no exclusion criteria for PACU Nurses

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Ken B Johnson, MD, University Of Utah

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: September 6, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimated): November 11, 2016

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ventilatory depression
• Other Study ID Numbers: 93779

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes