Use of Back Support After Transfemoral Angiography

Effect of Back Support on Vital Signs and Comfort After Transfemoral Angiography

In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Engagement; Femoral Angiography
• Intervention / Treatment: Other: Back Support

Detailed Description

In the routine treatment procedure after coronary angiography (CAG), the patients remain in the supine position for a long time, which leads to decreased venous return and back pain. In addition, lying in the same position for 2 hours or more in the back area causes an increase in pressure. Increased pressure disrupts cell and tissue blood supply. The resulting pain may increase sympathetic stimulation. Therefore, sympathetic stimulation increases heart rate, blood pressure, myocardial oxygen consumption and cardiac workload. After the transfemoral coronary angiography (CAG) procedure, which is frequently applied to adults for both diagnosis and treatment, the back support to be applied to ensure that the vital signs (pulse, blood pressure, respiratory rate and blood oxygen saturation) of the patients remain stable and to increase their comfort level can prevent the deviation of the vital signs of the patients from normal and contribute to the treatment process with patient satisfaction.

This study will be conducted to evaluate the effect of back support on patients undergoing transfemoral angiography on the patients' vital signs, which are defined as pulse, blood pressure, respiratory rate and blood oxygen saturation (SPO2), as well as comfort levels indicating satisfaction levels.

The study is planned to be completed between September 1, 2024 and April 1, 2025. The universe of the study, which was conducted as a randomized controlled trial model, consisted of patients who underwent angiography in the cardiovascular surgery intensive care units of Tunceli State Hospital. Randomization of the participants was planned to be assigned to the experimental and control groups via random.org (Back support group=40, Control group=40). "Patient Information Form", "Visual Analog Scale (VAS)" and "Immobilization Comfort Scale (IMC)" will be used in data collection. General linear model and mixed ANOVA analysis will be performed according to the characteristics of the data.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dilek Olmaz, PhD; Phone Number: +90 5349598752; Email: dilekolmaz62@hotmail.com
• Study Contact Backup: Name: Mensure Turan, PhD; Phone Number: +90 536 412 51 21; Email: mensurekyn@gmail.com

Study Locations

• Turkey
  • Tunceli, Turkey
    • Tunceli State Hospital
    • Contact: Mehdi Onaç, specialist doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients over the age of 18 who underwent femoral coronary angiography,
• Patients who did not have verbal communication problems,
• Patients who consented to participate in the study were determined as patients.

Exclusion Criteria:

• Patients who underwent radial angiography,
• Have chronic low back pain,
• Have had previous back surgery/herniated disc,
• Have coagulation problems (PLT<50000 mm3),
• Did not consent to participate in the study,
• Have communication problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Back Gupport Group; After the transfemoral angiography procedure, the patient will be taken to bed and monitored. Approximately 2 hours after the procedure, under the control of the doctor and nurse, the sheath in the patient's groin area will be pulled and a 3 kg sandbag will be left. A 36x33x10 cm gel-containing visco pillow will be placed in the patient's lumbar cavity by the research nurse and primary nurse to fill the anatomical space. The patient will be monitored in a supine position with the head elevated (30 degrees) and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours.	Other: Back Support; When the sandbag is to be left by the researcher together with the nurse caring for the patient, the patient will be placed in the left lateral position for a short time, a gel-filled orthopedic non-sweating viscose pillow will be placed in the patient's lumbar region and the patient will be placed in a supine position with the head supported.
No Intervention: Control Group; The patients in this group will be monitored in the supine position with the head elevated (30 degrees) without pillow support and blood pressure, pulse, respiratory rate, oxygen saturation and comfort and pain level will be recorded at 0, 3 and 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of back support use on pulse	Patients will be monitored for 6 hours in a supported supine position and Pulse will be recorded at 3-hour intervals.	6 hour (Data collection time for each patient)
Effect of back support use on blood pressure	Patients will be monitored for 6 hours in a supported supine position and blood pressure will be recorded at 3-hour intervals.m	6 hour (Data collection time for each patient)
Effect of back support use on respiratory rate	Patients will be monitored for 6 hours in a supported supine position and respiratory rate will be recorded at 3-hour intervals.m	6 hour (Data collection time for each patient)
Effect of back support use on partial oxygen saturation	Patients will be monitored for 6 hours in a supported supine position and partial oxygen saturation will be recorded at 3-hour intervals.m	6 hour (Data collection time for each patient)
Effect of back support use on comfort	The immobilization comfort scale consists of 20 items and 6 statements. The total score is between 20 and 120. Scoring was done before and after back support.	6 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of back support use on pain	The numbers on the pain scale (VAS) are ranked from 0 to 10 at equal intervals, with pain intensity of 1-3 indicating mild pain; 4-6 indicating moderate pain; and 7-10 indicating severe pain. Scoring was done at 0th hour (before back support), 3rd hour (during back support) and 6th hour (after back support).	6 hour

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: comfort; vital signs; back support; femoral angiography
• Other Study ID Numbers: 2024/5744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No