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

NCT05446987 | Completed

• 1 other identifier: Transfemoral Complication
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

coronary angiography; Complications; Early ambulation; Position; Transfemoral; Back massage

Outcome Measures

Primary Outcomes (3)

• Oozing and bleeding scale

  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.

  After six hours post transfemoral coronary angiography

• Ecchymosis and hematoma formation scale

  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.

  After six hours post transfemoral coronary angiography

• Numeric rating scale

  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).

  After six hours post transfemoral coronary angiography

Study Arms (2)

Position change and back massage group

EXPERIMENTAL

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

Other: Position change and back massage

Early ambulation

EXPERIMENTAL

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.

Other: Early ambulation

Interventions

Position change and back massage 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

Position change and back massage group

Early ambulation OTHER

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

Early ambulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (4)

• 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.

  PMID: 8416329 BACKGROUND

• 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.

  PMID: 23076977 BACKGROUND

• 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.

  PMID: 8665340 BACKGROUND

• 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.

  PMID: 9286529 BACKGROUND

MeSH Terms

Conditions

Mobility Limitation; Hemorrhage; Back Pain; Hematoma

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Alexandria University

  Faculty of Nursing, Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: March 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)