Pressure InjuryAPAMNCT06151327
Alternating Pressure Air Mattress and Pressure Injury Prevalence
An observational study of Pressure Injury and Alternating Pressure Air Mattress, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
explore the correlation of accurate implementation of APAM and pressure injury prevalence Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Injury, Alternating Pressure Air Mattress, Implementation
- How many people
- 50,419 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2023to 1 Nov 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients in hospital with pressure injury
Who may be able to join
- patients with pressure injury
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explore the Relationship Between Implementation of Alternating Pressure Air Mattress and Pressure Injury Prevalence
explore the correlation of accurate implementation of APAM and pressure injury prevalence
- Medical subject headings
- Pressure Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of full thickness pressure injury
total number of full thickness pressure injuries devided by total number of pressure injuries
Measured: 2020/1 ~2023/8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start20 Oct 2023
- Primary completion31 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Hsiu Chang, Principal investigator, National Taiwan University Hospital Yunlin brach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151327
- Sponsor's protocol ID
- 202309095RINA
- Acronym
- APAM
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Relationship Between Implementation of Alternating Pressure Air Mattress and Pressure Injury Prevalence
- ClinicalTrials.gov ID
- NCT06151327
- Acronym / sponsor ID
- APAM / 202309095RINA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,419 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 30 Nov 2023 (actual)
- 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.
explore the correlation of accurate implementation of APAM and pressure injury prevalence
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients in hospital with pressure injury
Key inclusion criteria (1 listed)
- patients with pressure injury
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of full thickness pressure injury
Time frame: 2020/1 ~2023/8
total number of full thickness pressure injuries devided by total number of pressure injuries
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 30 Nov 2023.
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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.
Hui-Hsiu Chang principal investigator
National Taiwan University Hospital Yunlin brach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Injury and Alternating Pressure Air Mattress, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 30 Nov 2023. 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 Taiwan. 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?
proportion of full thickness pressure injury (time frame: 2020/1 ~2023/8). 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 30 Nov 2023.