Clinical trial NCT06705361: Ice Bag, TR Band, and Air Compression Effects on Radial Line Removal Outcomes in Open Heart Surgery: A Clinical Trial
Official title: Effect of Ice-Bag Pressure, Transparent Radial Artery (TR) Band Compression Device-Screw, and Air Types on Early Complications and Patient Comfort After Radial Arterial Line Removal in Open Heart Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Disease
Keywords: Ice-bag, TR band device, RA. line removal, Open heart
Lead sponsor: University of Baghdad
Sponsor class: OTHER
Collaborators: name: Personalis Inc.
First posted: 2024-11-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This study will be designed as a randomized control trial (RCT). A randomized controlled trial (RCT) is a research method that encompasses prospective, comparative, quantitative, genuine experimental, and post-test-only control group designs. This type of design will conduct under controlled conditions which allows the researcher to assigned interventions randomly to different groups in order to minimize bias and understand the best cause-and-effect relationship between independent variables (Ice-bag pressure, TR radial band compression device-screw type, and TR radial band compression device-air type) and dependent variables (early complication; bleeding severity, hematoma formation, and patient comfort), as well as this study will utilize the effect of an ice-bag pressure, TR radial band compression device-screw type, and TR radial band compression device-air type as interventions to measure their effectiveness in the reducing of early complication; bleeding severity, hematoma formation, and patient comfort following to radial arterial line removal after open heart surgery and which intervention is more effective. Each individual participating in this study will have an equal chance of being assigned to either the experimental or control group.

Setting:

The research will be carried out at the Ibn Al-Bitar center for cardiac surgery, which has five rooms dedicated to open heart surgery, twelve beds for the postoperative cardiac intensive care unit (CICU), and four beds for the high dependency unit (HDU). Additionally, the Iraqi center for heart disease will be used, which has three rooms for open heart surgery, five beds for post-operative cardiac intensive care unit (CICU), and three beds for high dependency unit (HDU). Situated in the Baghdad governorate, this is a government-operated specialized facility dedicated to open heart surgery and cardiac catheterization. The facilities consistently carry out surgical procedures on approximately 3 cases per day, 15 cases per week, 60 cases per month, and over 720 cases per year, along with emergency operations following a predetermined schedule. This allows for reliable evaluation of the administrative feasibility and availability of the study population.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria:

Eligible male and female patients who are willing to participate and will have their radial artery lines removed after open heart surgery will be chosen based on specific inclusion criteria. The requirements are as follows: the patient must be at least eighteen years old, orientated, free of visual or auditory impairments, able to communicate orally in Arabic, having a radial intervention which include the insertion of a single arterial line in the radial region, and not taken analgesics for a minimum of three hours.

Exclusion Criteria:

* Exclusion criteria:

The study's exclusion criteria include patients who are unable to communicate due to visual impairment or hearing impairment, as effective communication is essential for data gathering; patients with cognitive disorders; patients experiencing hemodynamic instability, as the implementation of the program necessitates patient compliance; patients with bleeding and hematoma in the radial artery region before arterial line removal; patients with clotting factor disorders; patients with arterial line cutdown; and patients with a documented history of radial disease.

Primary outcomes:
measure: To assess the comfort level during the procedure as measured by the Numerical Visual Rating Comfort Scale (NVRC scale).
timeFrame: Baseline, within procedure time
Secondary outcomes:
Other outcomes:
Locations:
city: Karbala
country: Iraq
facility: Ali Abdul-Rasool Abbas
state: Al-bahadliya
Study officials:
affiliation: University of Baghdad / College of Nursing
name: Ali Abdul-Rasool Abbas, Student
role: PRINCIPAL_INVESTIGATOR
References: