Pulse Oximetry With Automated Verbal Prompts

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930863
• Other study ID #: IRB201600061
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: August 13, 2019

Study information

• Verified date: August 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 13, 2019
• Est. primary completion date: October 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia

Intervention

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%.

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.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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