Incidences of Cuff-related Trauma After Noninvasive Blood... | NCT02614976

Studies
Incidences of Cuff-related Trauma After Noninvasive Blood Pressure Measurement Between With and Without Padding

NCT02614976

Sponsor

Siriraj Hospital

Status

Completed

Last Update Posted

Feb 19, 2018Actual

Enrollment

273Actual

Phase

Not Applicable

Conditions

Complication

Interventions

Padding

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Aug 2017Actual

Completion Date

Feb 2018Actual

First Submitted Date

Nov 23, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2018

Last Update Posted Date

Feb 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

273Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	No padding before application of blood pressure cuff
Padding	Experimental	Padding before application of blood pressure cuff	Device: Padding

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Padding	Device	Padding webrill (Covidian) TM 6"	Padding

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication of a non-invasive blood pressure cuff	Petechiae and skin crease	5 minutes after completion of non-invasive blood pressure measuring

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Health volunteer age > 18 or patients

Exclusion Criteria:

Peripheral vascular disease
Difference of blood pressure both arms > 15 mmHg
Acute dermal cappillary rupture
Phlebitis
Skin necrosis
Acute radial nerve injury
Deep vein thrombosis
Rumpel-Leede phenomenon
Compartment syndrome

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mingkwan Wongyingsinn, M.D.	Siriraj Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siriraj hospital		Bangkoknoi	Bangkok	10700	Thailand