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NCT02962557
Detecting Post-surgical Respiratory Compromise and Prompting Patients to Self-rescue: An Early Feasibility Study
Conditions: Anesthesia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: University of Utah
Location: University of Utah Salt Lake City Utah
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT02962557). StuddyBuddy aggregates publicly available trial information.