Catheter ComplicationsNCT05446987
Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
A study testing Position change and back massage and Early ambulation in people with Catheter Complications and Ambulation Difficulty, run by Alexandria University at 1 site in Egypt.
Trial summary
The study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Catheter Complications, Ambulation Difficulty, Bleeding
- What is being tested?
- Position change and back massage and Early ambulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
The study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications.
Read the 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
- Being tested
- Position change and back massage, Early ambulation
- Keywords
- coronary angiography, Complications, Early ambulation, Position, Transfemoral, Back massage
- Medical subject headings
- Mobility Limitation, Hemorrhage, Back Pain, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Position change and back massageOther
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 ambulationOther
The patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Early ambulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: After six hours post transfemoral coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Mar 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Catheter ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suad Elsaman, Alexandria University
- Investigators
- Alexandria University, Study chair, Faculty of Nursing, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446987
- Sponsor's protocol ID
- Transfemoral Complication
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 8416329Kim 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.
PubMed 23076977Steffenino 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.
PubMed 8665340Wood 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.
PubMed 9286529
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
- ClinicalTrials.gov ID
- NCT05446987
- Acronym / sponsor ID
- Transfemoral Complication
- Conditions
- Catheter Complications, Ambulation Difficulty, Bleeding, Back Pain, Oozing, Hematoma
- Keywords
- coronary angiography, Complications, Early ambulation, Position, Transfemoral, Back massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Position change and back massage group | Experimental | Other: Position change and back massageThe 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 |
| Early ambulation | Experimental | Other: Early ambulationThe patient are allowed to ambulate after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (8 listed)
- Patients who had a history of previous coronary stents.
- chronic pain,
- chronic obstructive pulmonary disease.
- Renal failure,
- Hypercoagulable conditions such as protein C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Position change and back massageChanging 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 | Other | Position change and back massage group |
| Early ambulationThe patient ambulated after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle | Other | Early ambulation |
Primary outcome
Oozing and bleeding scale
Time frame: 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.
Ecchymosis and hematoma formation scale
Time frame: 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.
Numeric rating scale
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 8416329Lau 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.
- Background: PubMed 23076977Kim 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.
- Background: PubMed 8665340Steffenino 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.
- Background: PubMed 9286529Wood 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandria University study chair
Faculty of Nursing, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Position change and back massage and Early ambulation in people with Catheter Complications and Ambulation Difficulty, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oozing and bleeding scale (time frame: After six hours post transfemoral coronary angiography). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446987, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.