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

February 16, 2018 updated by: Mingkwan Wongyingsinn, MD, Siriraj Hospital
Padding with cuff during blood pressure is expected to reduce number of skin crease or petechiae incidence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

273

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No padding before application of blood pressure cuff
Experimental: Padding
Padding before application of blood pressure cuff
Device: Padding
Padding webrill (Covidian) TM 6"

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Study Director: Mingkwan Wongyingsinn, M.D., Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

November 23, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SIRB157

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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