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Completed

NCT Number: NCT03380065

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Radial Artery Injury Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Qaboos University Hospital

Muscat, Alkhod, 123, Oman

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Late deflation of TR band

Device
  • 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

Early deflation of TR band

Device
  • 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 outcomes

  1. Total deflation time

    Time frame: 2 hours

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

Secondary outcomes

  1. 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. 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

Sponsors and collaborators

Lead sponsor

Sultan Qaboos University

Other

Registry information

Official study title

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

Acronym: SQUARE1

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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