Clinical trial NCT05446987: Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
Official title: Effect of Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Complications
Ambulation Difficulty
Bleeding
Back Pain
Oozing
Hematoma
Keywords: coronary angiography
Complications
Early ambulation
Position
Transfemoral
Back massage
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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".

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.

Primary outcomes:
measure: Oozing and bleeding scale
timeFrame: After six hours post transfemoral coronary angiography
measure: Ecchymosis and hematoma formation scale
timeFrame: After six hours post transfemoral coronary angiography
measure: Numeric rating scale
timeFrame: After six hours post transfemoral coronary angiography
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Faculty of Nursing, Alexandria University
name: Alexandria University
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.