Ice Bag, TR Band, and Air Compression Effects on Radial Line Removal Outcomes in Open Heart Surgery: A Clinical Trial

NCT06705361 | Not Yet Recruiting

• 1 other identifier: UOB. CON. 24. 002
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to find the different effects of applying an ice-bag pressure, TR radial band compression device-screw type, and TR radial band compression device-air type on early complications and comfort among patients undergoing radial arterial line removal after open heart surgery.

Conditions

Cardiac Disease

Keywords

Ice-bag, TR band device, RA. line removal, Open heart

Outcome Measures

Primary Outcomes (1)

• To assess the comfort level during the procedure as measured by the Numerical Visual Rating Comfort Scale (NVRC scale).

  NVRC scale measures overall comfort on a 0-10 scale as follows: "No comfort" (0), "Negligible comfort" (1), "Moderate comfort" (2), "Moderate comfort" (3), "Moderate comfort" (4), "Moderate comfort" (5), "Moderate and fairly high comfort" (6), "Fairly high comfort" (7), "Very high comfort" (8), "Highest comfort possible" (9), A ruler is used to quantify the distance (0 mm) between the anchor and the mark specified by the client on the NVRC scale.

  Baseline, within procedure time

Study Arms (3)

Transparent Radial Band Compression Device (Screw-Type)

EXPERIMENTAL

To perform TR Band Compression Device (Screw Type) placement after radial arterial line removal, position the patient with the forearm and wrist exposed, ensuring privacy. Place an absorbent pad under the area and clean the puncture site with povidone. Withdraw the radial arterial line by 2-3 cm and secure the TR Band Compression Device with the strap, ensuring it is tight enough to prevent spinning. Adjust the screw cap to control pressure, gradually removing the line while maintaining hemostasis. Use the reverse Barbeau's test to confirm radial artery patency and adjust pressure as needed. After bleeding stops, unfasten the band while stabilizing the site, clean any blood, and apply a sterile gauze dressing. Reassess hand perfusion to ensure adequate blood flow.

Device: Transparent Radial Artery Band (Screw-Type)

Transparent Radial Band Compression Device (Air-Type)

EXPERIMENTAL

To perform TR Band Compression Device (Air Type) placement after radial arterial line removal, position the patient with the forearm and wrist exposed, ensuring privacy. Place an absorbent pad under the area and clean the puncture site with povidone. Withdraw the radial arterial line by 2-3 cm and secure the TR Band with the strap, aligning the green marker 1-2 mm proximal to the puncture site. Inflate the balloon with 15-18 mL of air using the syringe, removing the arterial line as the balloon inflates. Titrate air by removing 1 mL per minute while monitoring for bleeding or deflate in one step. Use the reverse Barbeau's test to confirm radial artery patency and adjust air volume as needed. Once hemostasis is achieved, deflate the band, unfasten it, clean the site, and apply a sterile gauze dressing. Reassess hand perfusion to ensure adequate blood flow.

Device: Transparent Radial Artery Band (Screw-Type)

Ice-Bag Pressure

EXPERIMENTAL

Titrate pressure using the TR Band's mechanical screw cap to maintain patent hemostasis. If bleeding occurs during pressure release, restore compression. Confirm radial pulse and evaluate artery patency using the reverse Barbeau's test. Place an oxygen saturation probe on the thumb or index finger and compress the ulnar artery, observing the waveform. If absent, reduce pressure until the waveform returns, ensuring antegrade flow. Once pressure is fully released, confirm bleeding has stopped. Stabilize the access site, unfasten, and remove the band slowly. Clean any blood with sterile gauze, apply a dressing (not encircling the wrist), and reassess hand perfusion. Ensure proper positioning for left or right wrist use.

Device: Transparent Radial Artery Band (Screw-Type)

Interventions

Transparent Radial Artery Band (Screw-Type) DEVICE

The researcher will randomly assign patients undergoing radial arterial line removal after open heart surgery into four groups: ice-bag pressure, transparent radial band compression device (screw type), transparent radial band compression device (air type), and control group. The researcher will assign specific card colors to each group: white for the control group, yellow for the ice-bag pressure group, pink for the Transparent Radial Band Compression Device - Screw Type group, and green for the Transparent Radial Band Compression Device - Air Type group. The researcher will place all these cards in a container, allowing the participant to select their preferred color, and then apply the intervention separately to each group.

Also known as: Transparent Radial Artery Band (Air-Type), Ice-Bag Pressure

Ice-Bag Pressure; Transparent Radial Band Compression Device (Air-Type); Transparent Radial Band Compression Device (Screw-Type)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Baghdad: lead
• Personalis Inc.: collaborator

Study Sites (1)

Ali Abdul-Rasool Abbas

Karbala, Al-bahadliya, 56001, Iraq

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Ali Abdul-Rasool Abbas, Student

  University of Baghdad / College of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Abdul-Rasool Abbas, Student

CONTACT

+9647719620138; ali.abd1605b@conursing.uobaghdad.edu.iq

Wafaa Abed Ali Hattab, Dr.

CONTACT

+9647707858731; Waffa.a@conursing.uobagdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: November 25, 2024
• Primary Completion: February 25, 2025
• Study Completion: March 25, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)