Pulse Oximetry With Automated Verbal Prompts

Prevention of Post Operative Hypoxia in the Post Anesthesia Care Unit Using Pulse Oximetry With Automated Verbal Prompts

This study will evaluate the effectiveness of an automated voice prompting system on post operative hypoxia within the Postoperative Anesthesia Care Unit (PACU). This will be done to detect an improvement of the patient experience and provider care through a decrease in the number of peripheral capillary oxygen saturation (SpO2) monitor alarms via the patients own ability to follow the instruction and improve their SpO2 levels.

Study Overview

• Status: Completed
• Conditions: Hypoxemia
• Intervention / Treatment: Behavioral: Brief post-PACU stay survey.; Other: pulse oximetry software

Detailed Description

The investigators will examine and observe the patient's stay in the PACU and utilize the pulse oximetry software and data to analyze the ability to evaluate the difference in patient oxygenation levels and supplemental oxygen use with automated verbal prompted monitoring versus a standard care control group. As well as determine if automated verbal prompted monitoring leads to less monitor alarms and subsequent improvement of subjective alarm fatigue and patient satisfaction with their care versus standard care.

The pulse oximeter will have a finger probe that will be attached to the patient's middle finger to read the patient's SpO2 levels. Each time the participant's pulse oximetry value declines to 93% or less, an automated verbal prompt, created via the software, will generate as a soft prompt. This will be followed up by a hard prompt if no improvement is seen in their oxygenation level after a period of time. A positive feedback elicitation will be given if the participant's saturation levels increase above 93%. This automated verbal prompt guidance will take place during the entirety of the investigational group's PACU stay.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• planned general anesthetic
• ability to provide informed consent

Exclusion Criteria:

• use of regional anesthesia
• altered mental status
• hearing impairment requiring assistive devices
• inability to hear normal conversational voice during the consent process
• inability preoperatively to squeeze probe finger against thumb for any reason
• baseline SpO2 less than or equal to 93% (on room air or baseline home oxygen requirement)
• history of methemoglobinemia
• suspected or confirmed carbon monoxide (CO) poisoning
• planned admission to an intensive care unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Non-Automated Group; Participants assigned to this group will receive the standard of care procedures for the monitoring and treatment of hypoxemia. Complete brief post-PACU stay survey.	Behavioral: Brief post-PACU stay survey.; Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU.
Experimental: Automated Prompt Group; Participants assigned to this group will utilize the automated verbal prompts to enable their ability to improve their current condition by following generated commands. Complete a questionnaire focused around their experience with the pulse oximetry software and its effects on the patient's satisfaction and experience.	Behavioral: Brief post-PACU stay survey.; Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU.; Other: pulse oximetry software; This pulse oximetry software will utilize automated verbal prompts that direct the patients to breathe when their pulse oximetry reading falls at or below 93%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the frequency of a participant's SpO2 level falling below 87%	SpO2 will be monitored using the standard pulse oximeter system	Change from baseline up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change between the study groups number of pulse oximetry alarms	SpO2 will be monitored using the standard physiologic monitoring system	Change from baseline up to 24 hours
Change between the study groups level of alarm fatigue	Number of participants reporting a decreased level of alarm noise	Change from baseline up to 24 hours
Change between the study groups level of postoperative care satisfaction	Number of participants reporting alarm noise affected their level of postoperative care satisfaction	Change from baseline up to 24 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Samsun Lampotang, Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): October 6, 2017
• Study Completion (Actual): August 13, 2019

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 10, 2016
• First Posted (Estimate): October 12, 2016

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: IRB201600061

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: No