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

April 2, 2019 updated by: SUNIL NADAR, Sultan Qaboos University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Oman
    • Alkhod
      • Muscat, Alkhod, Oman, 123
        • Sultan Qaboos University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Late deflation of TR band
  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
  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.
Other Names:
  • Late deflation
Active Comparator: Early deflation of TR band
  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
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total deflation time
Time Frame: 2 hours
To see how quickly the band can be removed in each arm
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staff satisfaction
Time Frame: 2 hours
using a visual analogue scale (from 1-10 where 1 is totally dissatisfied and 10 is completely satisfied
2 hours
Patient satisfaction
Time Frame: 2 hours
using a visual analogue scale (from 1-10 where 1 is extremely painful and uncomfortable and 10 is totally unpainful and comfortable
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Qaboos University

Investigators

  • Principal Investigator: Adil Riyami, MD, Sultan Qaboos University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2018

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

January 20, 2019

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SQUARE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The data regarding the time of band deflations and patient and staff satisfaction scores

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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