ComplicationNCT02614976
Incidences of Cuff-related Trauma After Noninvasive Blood Pressure Measurement Between With and Without Padding
A study testing Padding in people with Complication, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication
- What is being tested?
- Padding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to Feb 2018
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health volunteer age > 18 or patients
Who cannot join
- Peripheral vascular disease
- Difference of blood pressure both arms > 15 mmHg
- Acute dermal cappillary rupture
- Phlebitis
- Skin necrosis
- Acute radial nerve injury
Show all 9Show fewer
- Deep vein thrombosis
- Rumpel-Leede phenomenon
- Compartment syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence.
Read the detailed description
Objective Primary Outcome : incidences of skin crease or petichiae after noninvasive blood pressure measurement ievery 5 minutes for 1 hour Secondary Outcome : factor related truma after noninvasive blood pressure measurement.
- Conditions
- Complication
- Being tested
- Padding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaddingDevice
Padding webrill (Covidian) TM 6"
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No padding before application of blood pressure cuff |
| Padding | Experimental | Padding before application of blood pressure cuff Receives: Device: Padding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication of a non-invasive blood pressure cuff
Petechiae and skin crease
Measured: 5 minutes after completion of non-invasive blood pressure measuring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startJan 2014
- Primary completionAug 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Mingkwan Wongyingsinn, M.D., Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614976
- Sponsor's protocol ID
- SIRB157
- Status last verified
- Feb 2018
- First submitted
- 23 Nov 2015
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidences of Cuff-related Trauma After Noninvasive Blood Pressure Measurement Between With and Without Padding
- ClinicalTrials.gov ID
- NCT02614976
- Acronym / sponsor ID
- SIRB157
- Conditions
- Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Nov 2015 (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.
Padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence.
Detailed description
Objective Primary Outcome : incidences of skin crease or petichiae after noninvasive blood pressure measurement ievery 5 minutes for 1 hour Secondary Outcome : factor related truma after noninvasive blood pressure measurement.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No padding before application of blood pressure cuff |
| Padding | Experimental | Device: PaddingPadding before application of blood pressure cuff |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Health volunteer age > 18 or patients
Key exclusion criteria (9 listed)
- Peripheral vascular disease
- Difference of blood pressure both arms > 15 mmHg
- Acute dermal cappillary rupture
- Phlebitis
- Skin necrosis
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 |
|---|---|---|
| PaddingPadding webrill (Covidian) TM 6" | Device | Padding |
Primary outcome
Complication of a non-invasive blood pressure cuff
Time frame: 5 minutes after completion of non-invasive blood pressure measuring
Petechiae and skin crease
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 19 Feb 2018.
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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.
Mingkwan Wongyingsinn, M.D. study director
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Padding in people with Complication, run by Siriraj Hospital at 1 site in Thailand.
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 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 19 Feb 2018. 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 Thailand. 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?
Complication of a non-invasive blood pressure cuff (time frame: 5 minutes after completion of non-invasive blood pressure measuring). 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 19 Feb 2018.