NCT02614976

Brief Summary

Padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

3.6 years

First QC Date

November 23, 2015

Last Update Submit

February 16, 2018

Conditions

Complication

Outcome Measures

Primary Outcomes (1)

  • Complication of a non-invasive blood pressure cuff

    Petechiae and skin crease

    5 minutes after completion of non-invasive blood pressure measuring

Study Arms (2)

Control

NO INTERVENTION

No padding before application of blood pressure cuff

Padding

EXPERIMENTAL

Padding before application of blood pressure cuff

Device: Padding

Interventions

PaddingDEVICE

Padding webrill (Covidian) TM 6"

Padding

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health volunteer age \> 18 or patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Study Officials

  • Mingkwan Wongyingsinn, M.D.

    Siriraj Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 25, 2015

Study Start

January 1, 2014

Primary Completion

August 1, 2017

Study Completion

February 1, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

TH(1)