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

Coronary Artery Disease Clinical Trial

— SQUARE1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380065
• Other study ID #: SQUARE1
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: January 20, 2019

Study information

• Verified date: April 2019
• Source: Sultan Qaboos University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Coronary angiography is a procedure by which the anatomy of the coronary arteries are studied. It can be done either via the radial artery approach or the femoral artery approach. Currently most centers use the radial artery approach due to the lower risk of access site bleeding as compared to the femoral artery approach. In addition, the radial approach allows earlier patient mobilisation after the procedure.

Once the sheath, through which the procedure is done, is removed, a special air filled band is used to compress the artery to prevent bleeding. This involves filling the band with around 18 ml of air and then releasing the air at periodic intervals. There are however no set protocols for the removal of air and literature often suggests varying protocols. However what the protocols try to achieve is proper hemostasis, with low incidence of radial artery occlusion. In addition to these, patient comfort and safety along with staff ease of use is important. Some protocols involve frequent deflations which might be more tedious for the nurses, but more comfortable for patients whilst others might be easier for the staff (due to longer intervals), but more uncomfortable for the patients. However, there are no studies that actually compare these protocols

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 20, 2019
• Est. primary completion date: January 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing coronary procedures via the radial route

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Radial Artery Injury

Intervention

Device:
• Late deflation of TR band
First 3ml of air is removed after TWO hour of sheath removal. Then, 3ml of air is removed every 15minutes. 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.
• Early deflation of TR band
First 2ml of air is removed from the band ONE hour after sheath removal. Then, 2ml of air is removed every 30minutes. 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.

Locations

Country	Name	City	State
Oman	Sultan Qaboos University Hospital	Muscat	Alkhod

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Qaboos University

Country where clinical trial is conducted

Oman, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total deflation time	To see how quickly the band can be removed in each arm	2 hours
Secondary	Staff satisfaction	using a visual analogue scale (from 1-10 where 1 is totally dissatisfied and 10 is completely satisfied	2 hours
Secondary	Patient satisfaction	using a visual analogue scale (from 1-10 where 1 is extremely painful and uncomfortable and 10 is totally unpainful and comfortable	2 hours