Steri-strips for Reducing Radial Artery Compression Duration (RACC)
Application of Steri-strips for Reducing the Duration of Post Procedure Radial Artery Compression Via Conventional Pneumatic Transradial Band: An Open-label Randomized Controlled Trial
The duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis. Consequently, the frequency of radial artery occlusion (RAO) will be much lower and post procedure patency of radial artery will be higher along with significant alleviation of pain duration.
Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch. Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis. The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method. In a study conducted by Faravash et al. in 2016, showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid, malar and cheek soft tissues with use of steri-strips with no reported safety concerns.
Therefore, the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression.
Studieöversikt
Detaljerad beskrivning
Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.
Treatment group. Pneumatic TR band compression with use of steri-strips
Control group. Pneumatic TR band compression alone
Method of radial artery compression after sheath removal:
Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.
Mechanical compression with use of steri-strips: After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour.
END POINTS:
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Sindh
-
Karachi, Sindh, Pakistan
- National Institute of Cardiovascular Diseases
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients undergoing coronary angiography through transradial approach
- Either gender with age ≥18 years
- Positive Barbeau test (type A to C)
Exclusion Criteria:
- Patients refuse to give consent
- Negative Barbeau test (type D)
- Patients with bleeding diathesis or on oral anticoagulation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment group
After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 to 2 hour.
|
Pneumatic TR band compression with use of steri-strips
|
|
Inget ingripande: Control group
Application of pneumatic TR band alone for 4 hours as per usual practice
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean of
Tidsram: Immediately after removal of TR band
|
Time duration of achieving hemostasis
|
Immediately after removal of TR band
|
|
Number of Participants with
Tidsram: After 24 hour of removal of TR band
|
Radial artery patency
|
After 24 hour of removal of TR band
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Participants with
Tidsram: Immediately after removal of TR band
|
Hematoma
|
Immediately after removal of TR band
|
|
Number of Participants with
Tidsram: Immediately after removal of TR band
|
Bleeding
|
Immediately after removal of TR band
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ERC-29/2021
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