Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications

Not Applicable

Completed

• Conditions: Hematoma; Back Pain; Bleeding; Oozing; Catheter Complications; Ambulation Difficulty
• Interventions: Other: Early ambulation; Other: Position change and back massage

• Registration Number: NCT05446987
• Lead Sponsor: Alexandria University

Brief Summary

The study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications.

Detailed Description

Post transfemoral coronary angiography (TFCA) may be associated with complications such as oozing, bleeding, ecchymosis, hematoma, and back pain. As a result, nursing practice must be geared toward enhancing patient safety post-transfemoral coronary angiography procedure. This study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications. A quasi-experimental research design was used to conduct this study at the Coronary Care Unit of the selected university hospital in Egypt. A convenience sample of 185 patients undergoing transfemoral coronary angiography was included in the study during the first 6 hours post-transfemoral coronary angiography and randomly assigned to two groups: 92 patients received position change and back massage (PCBM group), and 93 patients underwent early ambulation after the first 3 hours post-transfemoral coronary angiography (EA group). The used tool was "Post Transfemoral Coronary Angiography Complication Assessment".

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Last Update Submitted: 2022-07-01
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

• Mean arterial blood pressure ≥70 mmHg.
• Heart rate ≥ 60 b/m.
• Manual compression closure technique on the access site
• Partial thromboplastin time < 90 seconds.
• Prothrombin time <16 seconds).
• No anticoagulant therapy within 24 hours before the cardiac catheterization procedure.

Exclusion Criteria

• Patients who had a history of previous coronary stents.
• chronic pain,
• chronic obstructive pulmonary disease.
• Renal failure,
• Hypercoagulable conditions such as protein C.
• Cardiopulmonary resuscitation during angiography.
• Femoral artery ruptures during angiography.
• Chest pain with new electrocardiograph change.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early ambulation	Early ambulation	The patient are allowed to ambulate after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle.
Position change and back massage group	Position change and back massage	The patients received changing of position every two hours as follows in the same order: supine position with a head angle of 15°, semi-fowler position with a head angle of 30°, lateral right or left position with a head angle of 15°. Also, the patients received a simple stroke of lower back massage for 5 minutes every 2 hours

Primary Outcome Measures

Name	Time	Method
Ecchymosis and hematoma formation scale	After six hours post transfemoral coronary angiography	It was designed to measure ecchymosis and hematoma size. It classified ecchymosis and hematoma according to the surface area of blood collection under the skin into three items: (1) No ecchymosis or hematoma (no blood collection), (2) Ecchymosis (surface area \<2cm2), (3) Hematoma (surface area ≥ 2cm2). The researcher rated vascular complications on a dichotomous scale (Yes/No). The "Yes" response indicated the presence of complications and was given a score of one. On the other hand, the "No" response indicated the absence of complications and received a score of zero.
Oozing and bleeding scale	After six hours post transfemoral coronary angiography	It was designed to measure any leakage of blood from the puncture site. It classified oozing and bleeding according to the surface area of the dressing soaked with blood to three items: (1) No bleeding or oozing (dry dressing), (2) Oozing (surface area \< 2cm 2), (3) Bleeding (surface area ≥2cm 2).; The researcher rated vascular complications on a dichotomous scale (Yes/No). The "Yes" response indicated the presence of complications and was given a score of one. On the other hand, the "No" response indicated the absence of complications and received a score of zero.
Numeric rating scale	After six hours post transfemoral coronary angiography	The scale was used to assess the lower back pain intensity. It is a four-point numerical rating scale: no pain (0), mild pain (1-3), moderate pain (4-7), severe pain (8-10).

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt