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

Primary Purpose

Coronary Artery Disease, Radial Artery Injury

Status
Completed
Phase
Not Applicable
Locations
Oman
Study Type
Interventional
Intervention
Late deflation of TR band
Early deflation of TR band
Sponsored by
Sultan Qaboos University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary angiogram, radial artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sultan Qaboos University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Late deflation of TR band

Early deflation of TR band

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2017
Last Updated
April 2, 2019
Sponsor
Sultan Qaboos University
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1. Study Identification

Unique Protocol Identification Number
NCT03380065
Brief Title
Comparison of Two Protocols for Deflation of Radial Band Following Coronary Procedures Via the Radial Artery
Acronym
SQUARE1
Official Title
Comparison of Two Protocols for Deflation of Radial Band Following Coronary Procedures Via the Radial Route
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 30, 2018 (Actual)
Primary Completion Date
January 10, 2019 (Actual)
Study Completion Date
January 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sultan Qaboos University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Radial Artery Injury
Keywords
coronary angiogram, radial artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Late deflation of TR band
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Early deflation of TR band
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Late deflation of TR band
Other Intervention Name(s)
Late deflation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Early deflation of TR band
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total deflation time
Description
To see how quickly the band can be removed in each arm
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Staff satisfaction
Description
using a visual analogue scale (from 1-10 where 1 is totally dissatisfied and 10 is completely satisfied
Time Frame
2 hours
Title
Patient satisfaction
Description
using a visual analogue scale (from 1-10 where 1 is extremely painful and uncomfortable and 10 is totally unpainful and comfortable
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adil Riyami, MD
Organizational Affiliation
Sultan Qaboos University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sultan Qaboos University Hospital
City
Muscat
State/Province
Alkhod
ZIP/Postal Code
123
Country
Oman

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data regarding the time of band deflations and patient and staff satisfaction scores

Learn more about this trial

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

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