Pulse Oximetry With Automated Verbal Prompts

NCT02930863 | Completed

• 1 other identifier: IRB201600061
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change between the study groups number of pulse oximetry alarms

  Change from baseline up to 24 hours

• Change between the study groups level of alarm fatigue

  Change from baseline up to 24 hours

• Change between the study groups level of postoperative care satisfaction

  Change from baseline up to 24 hours

Study Arms (2)

Control Non-Automated Group

ACTIVE COMPARATOR

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.

Automated Prompt Group

EXPERIMENTAL

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.

Other: pulse oximetry software; Behavioral: Brief post-PACU stay survey.

Interventions

pulse oximetry software OTHER

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%.

Automated Prompt Group

Brief post-PACU stay survey. BEHAVIORAL

Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU.

Automated Prompt Group; Control Non-Automated Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned general anesthetic
• ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samsun Lampotang, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 12, 2016
• Study Start: November 1, 2016
• Primary Completion: October 6, 2017
• Study Completion: August 13, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)