Clinical trial NCT02930863: Pulse Oximetry With Automated Verbal Prompts
Official title: Prevention of Post Operative Hypoxia in the Post Anesthesia Care Unit Using Pulse Oximetry With Automated Verbal Prompts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the frequency of a participant's SpO2 level falling below 87%
timeFrame: Change from baseline up to 24 hours
Secondary outcomes:
measure: Change between the study groups number of pulse oximetry alarms
timeFrame: Change from baseline up to 24 hours
measure: Change between the study groups level of alarm fatigue
timeFrame: Change from baseline up to 24 hours
measure: Change between the study groups level of postoperative care satisfaction
timeFrame: Change from baseline up to 24 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Samsun Lampotang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: