Pulse Oximetry With Automated Verbal Prompts

Not Applicable

Completed

• Conditions: Hypoxemia
• Interventions: Other: pulse oximetry software; Behavioral: Brief post-PACU stay survey.

• Registration Number: NCT02930863
• Lead Sponsor: University of Florida

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Study Start: 2016-11
• Primary Completion: 2017-10-06
• Status Verified: 2019-08
• Study Completion: 2019-08-13
• Last Update Submitted: 2019-08-14
• Last Update Posted: 2019-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• planned general anesthetic
• ability to provide informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated Prompt Group	pulse oximetry software	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.
Control Non-Automated Group	Brief post-PACU stay survey.	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.
Automated Prompt Group	Brief post-PACU stay survey.	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States