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Pulse Oximetry With Automated Verbal Prompts

Primary Purpose

Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pulse oximetry software
Brief post-PACU stay survey.
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypoxemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Non-Automated Group

Automated Prompt Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in the frequency of a participant's SpO2 level falling below 87%
SpO2 will be monitored using the standard pulse oximeter system

Secondary Outcome Measures

Change between the study groups number of pulse oximetry alarms
SpO2 will be monitored using the standard physiologic monitoring system
Change between the study groups level of alarm fatigue
Number of participants reporting a decreased level of alarm noise
Change between the study groups level of postoperative care satisfaction
Number of participants reporting alarm noise affected their level of postoperative care satisfaction

Full Information

First Posted
October 10, 2016
Last Updated
August 14, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02930863
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 6, 2017 (Actual)
Study Completion Date
August 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Non-Automated Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Automated Prompt Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
pulse oximetry software
Intervention Description
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%.
Intervention Type
Behavioral
Intervention Name(s)
Brief post-PACU stay survey.
Intervention Description
Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU.
Primary Outcome Measure Information:
Title
Change in the frequency of a participant's SpO2 level falling below 87%
Description
SpO2 will be monitored using the standard pulse oximeter system
Time Frame
Change from baseline up to 24 hours
Secondary Outcome Measure Information:
Title
Change between the study groups number of pulse oximetry alarms
Description
SpO2 will be monitored using the standard physiologic monitoring system
Time Frame
Change from baseline up to 24 hours
Title
Change between the study groups level of alarm fatigue
Description
Number of participants reporting a decreased level of alarm noise
Time Frame
Change from baseline up to 24 hours
Title
Change between the study groups level of postoperative care satisfaction
Description
Number of participants reporting alarm noise affected their level of postoperative care satisfaction
Time Frame
Change from baseline up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samsun Lampotang, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulse Oximetry With Automated Verbal Prompts

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