HypoxemiaNCT02930863
Pulse Oximetry With Automated Verbal Prompts
A study testing pulse oximetry software and Brief post-PACU stay survey. in people with Hypoxemia, run by University of Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia
- What is being tested?
- pulse oximetry software and Brief post-PACU stay survey.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 13 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned general anesthetic
- ability to provide informed consent
Who cannot join
- 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)
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- history of methemoglobinemia
- suspected or confirmed carbon monoxide (CO) poisoning
- planned admission to an intensive care unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Post Operative Hypoxia in the Post Anesthesia Care Unit Using Pulse Oximetry With Automated Verbal Prompts
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.
Read the 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.
- Conditions
- Hypoxemia
- Being tested
- pulse oximetry software, Brief post-PACU stay survey.
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulse oximetry softwareOther
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%.
Brief post-PACU stay survey.Behavioural
Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: pulse oximetry software; Behavioral: Brief post-PACU stay survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of a participant's SpO2 level falling below 87%
SpO2 will be monitored using the standard pulse oximeter system
Measured: Change from baseline up to 24 hours
Secondary outcomes (3)
Change between the study groups number of pulse oximetry alarms
SpO2 will be monitored using the standard physiologic monitoring system
Measured: Change from baseline up to 24 hours
Change between the study groups level of alarm fatigue
Number of participants reporting a decreased level of alarm noise
Measured: Change from baseline up to 24 hours
Change between the study groups level of postoperative care satisfaction
Number of participants reporting alarm noise affected their level of postoperative care satisfaction
Measured: Change from baseline up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startNov 2016
- Primary completion6 Oct 2017
- Study completion13 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samsun Lampotang, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930863
- Sponsor's protocol ID
- IRB201600061
- Status last verified
- Aug 2019
- First submitted
- 10 Oct 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post Operative Hypoxia in the Post Anesthesia Care Unit Using Pulse Oximetry With Automated Verbal Prompts
- ClinicalTrials.gov ID
- NCT02930863
- Acronym / sponsor ID
- IRB201600061
- Conditions
- Hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 6 Oct 2017 (actual)
- Study completion
- 13 Aug 2019 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Non-Automated Group | Active comparator | Behavioral: 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 | Experimental | Other: pulse oximetry software, Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned general anesthetic
- ability to provide informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulse oximetry softwareThis pulse oximetry software will utilize automated verbal prompts that direct the patients to breathe when their pulse oximetry reading falls at or below 93%. | Other | Automated Prompt Group |
| Brief post-PACU stay survey.Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU. | Behavioural | Automated Prompt Group, Control Non-Automated Group |
Primary outcome
Change in the frequency of a participant's SpO2 level falling below 87%
Time frame: Change from baseline up to 24 hours
SpO2 will be monitored using the standard pulse oximeter system
3 secondary outcomes
Change between the study groups number of pulse oximetry alarms
Time frame: Change from baseline up to 24 hours
Change between the study groups level of alarm fatigue
Time frame: Change from baseline up to 24 hours
Change between the study groups level of postoperative care satisfaction
Time frame: Change from baseline up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samsun Lampotang, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulse oximetry software and Brief post-PACU stay survey. in people with Hypoxemia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the frequency of a participant's SpO2 level falling below 87% (time frame: Change from baseline up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.