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

Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614976
• Other study ID #: SIRB157
• Status: Completed
• Phase: N/A
• First received: November 23, 2015
• Last updated: February 16, 2018
• Start date: January 2014
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: February 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication

Intervention

Device:
• Padding
Padding webrill (Covidian) TM 6"

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication of a non-invasive blood pressure cuff	Petechiae and skin crease	5 minutes after completion of non-invasive blood pressure measuring