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

NCT ID: NCT05446987

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-08-01

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".

Conditions

Catheter Complications; Ambulation Difficulty; Bleeding; Back Pain; Oozing; Hematoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Position change and back massage group

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

Group Type: EXPERIMENTAL

Position change and back massage

Intervention Type: OTHER

Changing the patient's 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 researcher applied a simple stroke of lower back massage for 5 minutes every 2 hours

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.

Group Type: EXPERIMENTAL

Early ambulation

Intervention Type: OTHER

The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle

Interventions

Position change and back massage

Changing the patient's 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 researcher applied a simple stroke of lower back massage for 5 minutes every 2 hours

Intervention Type: OTHER

Early ambulation

The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Suad Elsaman

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandria University

Role: STUDY_CHAIR

Faculty of Nursing, Alexandria University

Locations

Alexandria University

Alexandria, , Egypt

Countries

Egypt

References

Lau KW, Tan A, Koh TH, Koo CC, Quek S, Ng A, Johan A. Early ambulation following diagnostic 7-French cardiac catheterization: a prospective randomized trial. Cathet Cardiovasc Diagn. 1993 Jan;28(1):34-8. doi: 10.1002/ccd.1810280107.

Reference Type: BACKGROUND

PMID: 8416329 (View on PubMed)

Kim K, Won S, Kim J, Lee E, Kim K, Park S. Meta-analysis of complication as a risk factor for early ambulation after percutaneous coronary intervention. Eur J Cardiovasc Nurs. 2013 Oct;12(5):429-36. doi: 10.1177/1474515112462519. Epub 2012 Oct 17.

Reference Type: BACKGROUND

PMID: 23076977 (View on PubMed)

Steffenino G, Dellavalle A, Ribichini F, Russo P, Conte L, Dutto S, Giachello G, Lice G, Tomatis M, Uslenghi E. Ambulation three hours after elective cardiac catheterisation through the femoral artery. Heart. 1996 May;75(5):477-80. doi: 10.1136/hrt.75.5.477.

Reference Type: BACKGROUND

PMID: 8665340 (View on PubMed)

Wood RA, Lewis BK, Harber DR, Kovack PJ, Bates ER, Stomel RJ. Early ambulation following 6 French diagnostic left heart catheterization: a prospective randomized trial. Cathet Cardiovasc Diagn. 1997 Sep;42(1):8-10. doi: 10.1002/(sici)1097-0304(199709)42:13.0.co;2-8.

Reference Type: BACKGROUND

PMID: 9286529 (View on PubMed)

Other Identifiers

Transfemoral Complication

Identifier Type: -

Identifier Source: org_study_id