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