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

NCT03380065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-04-04

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Principal Investigators

  • Adil Riyami, MD · Sultan Qaboos University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-30
Primary Completion
2019-01-10
Completion
2019-01-20

Countries

  • Oman

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03380065 on ClinicalTrials.gov