SQUARE1: Comparison of Two Protocols for Deflation of Radial Band Following Coronary Procedures Via the Radial Artery

Sponsor

Sultan Qaboos University (Other)

Overall Status

Completed

CT.gov ID

NCT03380065

Collaborator

(none)

200

Enrollment

Location

Arms

11.7

Actual Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Radial Artery Injury	Device: Late deflation of TR band Device: Early deflation of TR band	N/A

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomised controlled trialrandomised controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 30, 2018

Actual Primary Completion Date :

Jan 10, 2019

Actual Study Completion Date :

Jan 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Late deflation of TR band first 3ml of air removed from the TR band after TWO hour of sheath removal. Then, 3ml of air 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 wait for another 15minutes for the next deflation.	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. Other Names: Late deflation
Active Comparator: Early deflation of TR band First 2ml of air is removed from the TR 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 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 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.

Arm

Intervention/Treatment

Active Comparator: Late deflation of TR band

first 3ml of air removed from the TR band after TWO hour of sheath removal. Then, 3ml of air 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 wait for another 15minutes for the next deflation.

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.

Other Names:

Late deflation

Active Comparator: Early deflation of TR band

First 2ml of air is removed from the TR 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 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

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.

Outcome Measures

Primary Outcome Measures

Total deflation time [2 hours]
To see how quickly the band can be removed in each arm

Secondary Outcome Measures

Staff satisfaction [2 hours]
using a visual analogue scale (from 1-10 where 1 is totally dissatisfied and 10 is completely satisfied
Patient satisfaction [2 hours]
using a visual analogue scale (from 1-10 where 1 is extremely painful and uncomfortable and 10 is totally unpainful and comfortable

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sultan Qaboos University Hospital	Muscat	Alkhod	Oman	123

Sponsors and Collaborators

Sultan Qaboos University

Investigators

Principal Investigator: Adil Riyami, MD, Sultan Qaboos University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SUNIL NADAR, Senior Consultant, Sultan Qaboos University

ClinicalTrials.gov Identifier:

NCT03380065

Other Study ID Numbers:

SQUARE1

First Posted:

Dec 20, 2017

Last Update Posted:

Apr 4, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by SUNIL NADAR, Senior Consultant, Sultan Qaboos University

coronary angiogram

radial artery

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Apr 4, 2019