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

Primary Purpose

Catheter Complications, Ambulation Difficulty, Bleeding

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Position change and back massage
Early ambulation
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Catheter Complications focused on measuring coronary angiography, Complications, Early ambulation, Position, Transfemoral, Back massage

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Position change and back massage group

Early ambulation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
July 1, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05446987
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Complications, Ambulation Difficulty, Bleeding, Back Pain, Oozing, Hematoma
Keywords
coronary angiography, Complications, Early ambulation, Position, Transfemoral, Back massage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Position change and back massage group
Arm Type
Experimental
Arm Description
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
Arm Title
Early ambulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Position change and back massage
Intervention Description
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
Intervention Name(s)
Early ambulation
Intervention Description
The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle
Primary Outcome Measure Information:
Title
Oozing and bleeding scale
Description
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.
Time Frame
After six hours post transfemoral coronary angiography
Title
Ecchymosis and hematoma formation scale
Description
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.
Time Frame
After six hours post transfemoral coronary angiography
Title
Numeric rating scale
Description
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).
Time Frame
After six hours post transfemoral coronary angiography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandria University
Organizational Affiliation
Faculty of Nursing, Alexandria University
Official's Role
Study Chair
Facility Information:
Facility Name
Alexandria University
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8416329
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.
Results Reference
background
PubMed Identifier
23076977
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.
Results Reference
background
PubMed Identifier
8665340
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.
Results Reference
background
PubMed Identifier
9286529
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.
Results Reference
background

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

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