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.

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.

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