Comparison of Two Protocols for Deflation of Radial Band Following Coronary Procedures Via the Radial Artery

NCT03380065 | Completed

• 1 other identifier: SQUARE1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary angiography is now mainly performed via the radial route rather than the femoral route. At the end of the procedure, the sheath is removed and a band is inflated to obtain hemostasis. The air in the band is then deflated at regular intervals. Currently there are different protocols for deflation of the band, but none of these have been studied with regards to patient comfort and time of deflation, and potential complications such as bleeding. Here in this study the investigators wish to compare two such protocols of band deflation and assess the levels of patient comfort and time to discharge with two widely used protocols.

Conditions

Coronary Artery Disease; Radial Artery Injury

Keywords

coronary angiogram; radial artery

Outcome Measures

Primary Outcomes (1)

• Total deflation time

  To see how quickly the band can be removed in each arm

  2 hours

Secondary Outcomes (2)

• Staff satisfaction

  2 hours

• Patient satisfaction

  2 hours

Study Arms (2)

Late deflation of TR band

ACTIVE COMPARATOR

1. first 3ml of air removed from the TR band after TWO hour of sheath removal. Then, 3ml of air removed every 15minutes. 2. Observe for any bleeding or hematoma. During every deflation, if any bleeding or hematoma is noticed then 3ml of air is pushed back into the device until bleeding stops. Then wait for another 15minutes for the next deflation.

Device: Late deflation of TR band

Early deflation of TR band

ACTIVE COMPARATOR

1. First 2ml of air is removed from the TR band ONE hour after sheath removal. Then, 2ml of air is removed every 30minutes. 2. Observe for any bleeding or hematoma. During every deflation, if any bleeding or hematoma is noticed then push the 2ml of air back into the device until bleeding stops. Then wait for another 30minutes for the next deflation.

Device: Early deflation of TR band

Interventions

Late deflation of TR band DEVICE

1. First 3ml of air is removed after TWO hour of sheath removal. Then, 3ml of air is removed every 15minutes. 2. Observe for any bleeding or hematoma. During every deflation, if any bleeding or hematoma is noticed then 3ml of air is pushed back into the device until bleeding stops. Then a gap of 15minutes is observed for the next deflation.

Also known as: Late deflation

Late deflation of TR band

Early deflation of TR band DEVICE

1. First 2ml of air is removed from the band ONE hour after sheath removal. Then, 2ml of air is removed every 30minutes. 2. Observe for any bleeding or hematoma. During every deflation, if any bleeding or hematoma is noticed then 2ml of air should be pushed back into the device until bleeding stops. Then wait for another 30minutes for the next deflation.

Early deflation of TR band

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing coronary procedures via the radial route

You may not qualify if:

• Those below the age of 18 and those unable to give consent

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, Alkhod, 123, Oman

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Adil Riyami, MD

  Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: randomised controlled trial

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 20, 2017
• Study Start: January 30, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 20, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

OM (1)