Manual vs Pneumatic Compression to Prevent Radial Artery Occlusion After Transradial Procedures

NCT07621185 | Completed

• 2 other identifiers: HCB-RAO-HEMOSTASIS-2022HCB/2021/1166
• Study Type: interventional
• Target: 1,168
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates two commonly used methods of achieving hemostasis after transradial cardiac catheterization: manual compression and pneumatic compression with gradual deflation. Transradial access is widely used for diagnostic and interventional cardiac procedures due to its safety profile, but radial artery occlusion remains a relevant complication that may limit future vascular access. In this pragmatic, prospective, multicenter study conducted in routine clinical practice, adult patients undergoing transradial cardiac catheterization were assigned to receive either manual compression or pneumatic compression using a standardized patent hemostasis protocol. The primary objective is to compare the incidence of radial artery occlusion at 30 days between both strategies. Secondary outcomes include local vascular complications, patient-reported pain, and total compression time.

Conditions

Radial Artery Occlusion; Cardiac Catheterization

Keywords

Transradial Access; Patent Hemostasis; Radial Compression; Pneumatic Compression Device; Manual Compression; Interventional Cardiology

Outcome Measures

Primary Outcomes (1)

• Radial Artery Occlusion

  Radial artery occlusion assessed by absence of distal plethysmographic signal during radial artery compression using the Barbeau test.

  30 days

Secondary Outcomes (3)

• Local Vascular Complications

  During hospital stay and up to 30 days

• Pain During Compression

  Immediately after compression

• Total Compression Time

  During procedure

Study Arms (2)

Manual Compression

EXPERIMENTAL

Hemostasis achieved by direct manual compression using sterile gauze and a non-circumferential adhesive dressing, with progressive adjustment of pressure to maintain arterial patency. Compression duration was approximately 3-4 hours depending on the procedure.

Procedure: Manual Radial Compression

Pneumatic Compression

EXPERIMENTAL

Hemostasis achieved using a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol, ensuring bleeding control while maintaining arterial flow. The device was progressively deflated until complete removal.

Device: Pneumatic Radial Compression Device

Interventions

Manual Radial Compression PROCEDURE

Direct manual compression using sterile gauze and a non-circumferential adhesive dressing applied after radial sheath removal, with progressive pressure adjustment to achieve patent hemostasis.

Manual Compression

Pneumatic Radial Compression Device DEVICE

Application of a pneumatic compression device with gradual deflation following a standardized patent hemostasis protocol to maintain arterial flow while achieving hemostasis.

Pneumatic Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years
• Undergoing diagnostic or interventional cardiac catheterization via transradial access
• Preserved dual hand circulation confirmed by Barbeau test
• Ability to provide informed consent
• Ability to complete 30-day follow-up

You may not qualify if:

• Refusal to participate
• Inability to complete follow-up
• Abnormal collateral circulation (Barbeau type D)
• Initial failure of radial access
• Contraindication to prolonged radial compression

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Montserrat Pardo, RN

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were assigned in a 1:1 predefined alternating sequence to either manual radial compression or pneumatic compression with gradual deflation following sheath removal.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: November 2, 2022
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: June 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)