Use of Back Support After Transfemoral Angiography

Inonu University

Status: Not yet enrolling

Conditions: Patient Engagement; Femoral Angiography

Treatments: Other: Back Support

Study type: Interventional

Funder types: Other

Identifiers

NCT06643182

2024/5744

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Back Gupport Group

Experimental group

Description:

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.

Treatment:

Other: Back Support

Control Group

No Intervention group

Description:

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.