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

• Sponsor: Siriraj Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02614976
• Collaborator: (none)
• Enrollment: 273
• Location: 1
• Arms: 2
• Actual Duration (Months): 49
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Complication	Device: Padding	N/A

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

• Study Type: Interventional
• Actual Enrollment: 273 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Incidences of Cuff-related Trauma After Noninvasive Blood Pressure Measurement Between With and Without Padding
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

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"

Outcome Measures

Primary Outcome Measures

1. Complication of a non-invasive blood pressure cuff [5 minutes after completion of non-invasive blood pressure measuring]

   Petechiae and skin crease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siriraj hospital	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Siriraj Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mingkwan Wongyingsinn, MD, Dr., Siriraj Hospital
• ClinicalTrials.gov Identifier: NCT02614976
• Other Study ID Numbers: SIRB157
• First Posted: Nov 25, 2015
• Last Update Posted: Feb 19, 2018
• Last Verified: Feb 1, 2018

Study Results

No Results Posted as of Feb 19, 2018