Percutaneous Coronary InterventionNCT03611933
Effects of Position Change After PCI
A study testing position change applied at different times in people with Percutaneous Coronary Intervention and Coronary Artery Disease, run by Kocaeli University.
Trial summary
Aims and objectives: To determine the effect of position change that is applied after percutaneous coronary intervention on vital signs, back pain, and vascular complications. Background: In order to minimize the post-procedure complications, patients are restricted to prolonged bed rest that is always accompanied by… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Artery Disease
- What is being tested?
- position change applied at different times
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Nov 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age
- a 6-7 F catheter
- must be able to lie in a supine position (without breathing problems)
- must be in balance hemodynamically
Who cannot join
- hypotension
- hyperthermia or hypothermia
- no procedure except for PCI
- coagulation disorder
- decompensated heart failure
- diastolic blood pressure (DBP) > 100 mmHg
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- systolic blood pressure (SBP) > 180 mmHg
- vascular complications
- the femoral artery damage
- body mass index ≥ 35 kg/m2
- pre-treatment back pain
- vertebral disc disease
About this study
Official title: The Effect of Position Change on Vital Signs, Back Pain and, Vascular Complications Following Percutaneous Coronary Intervention
Aims and objectives: To determine the effect of position change that is applied after percutaneous coronary intervention on vital signs, back pain, and vascular complications.
Background: In order to minimize the post-procedure complications, patients are restricted to prolonged bed rest that is always accompanied by back pain and and hemodynamic instability.
Design: Randomized-controlled quasi experimental study Methods: The study sample chosen for this study included 200 patients who visited a hospital in Turkey between July 2014 and November 2014. Patients were divided into two groups by randomization. Patients in the control group (CG, n = 100) were put in a supine position, in which the head of the bed (HOB) was elevated to 15°, the patient's leg on the side of the intervention was kept straight and immobile; positional change was applied to patients in the experimental group (EG, n = 100).
Read the detailed description
Percutaneous coronary intervention (PCI) is an interventional procedure used to diagnose and treat chronic coronary artery disease. The recommended period of bed rest following a PCI is reported by Rolley et al. (2011) as being 2-4 hours (h). According to evidence-based guidelines in relevant literature, however, the bed rest was reported from 2-24 h; in these instances the supine position (SP) was used, which leads to movement limitation.
Among the patient-care goals during the post-procedural period, sustaining tissue perfusion and heart and vascular system operation, regulating vital signs, reducing pain, and supporting movement are important. According to such a procedure, the nurse's independent role is to provide the safest position for the patient, thereby positively affecting vital signs after PCI and reducing vascular complications and back pain.
Recently, similar nursing studies have reported the effect of position change after PCI on back pain, as well as vascular complications after PCI, the effect of position change on certain vital signs and vascular complications, the effect of position change regarding pain, patient comfort and certain vital signs, and the effect of positional change on intervention pain and all vital signs. Some studies have also looked into the effect of positional changes on back pain, certain vital signs, and vascular complication.
Prolonged bed rest in a SP has become tradition, but it can have negative effects. Comprehensive studies in the existing literature that can be applied to the post-PCI nursing care process-and which study the effect of the most reliable positional change on all vital signs, vascular complications, and, back pain-display a numerical inadequacy. Consequently, the authors intend the current study to be an experimental investigation of the effect of position change on vital signs, vascular complications, and back pain.
- Being tested
- position change applied at different times
- Keywords
- Back pain, patient positioning, vascular complications, vital signs
- Medical subject headings
- Coronary Artery Disease, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
position change applied at different timesOther
Time 1 - in the first fifth minute after the procedure supine position in which the HOB was elevated 15° Time 2 - in the first hour low fowler's position were given in which the HOB was elevated 15-30° Time 3 - in the third hour semi high fowler's position were given in which the HOB was elevated 30-45° Time 4 - in the fourth hour left or right lateral position were given in which the HOB was elevated 15° Time 5 - in the fifth hour low fowler's position were given in which the HOB was elevated 15-30° Time 6 - in the sixth hour standard fowler's position were given in which the HOB was elevated 45-60°
| Study group | Role | What they receive |
|---|---|---|
| Control group (CG) | No intervention | Patients in the CG were provided with routine nursing care, as practiced in the clinic, including restricted bed rest. For this purpose, patients were given supine position in which the HOB was elevated 15° for 6-10 h; the patient's leg on the of the side of intervention was kept straight. |
| Experimental group (EG) | Experimental | Patients in the EG were applied position changes between the first minute and sixth hour. During the initial six hours a supportive, thin pillow, 4 x 40 x 100 cm in size, was placed between the patient's shoulders and gluteals; this reduced the pressure on local tissues and muscle groups. Receives: Other: position change applied at different times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate (respiratory rate / min.)
physiological parameter - rate per minute
Measured: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
body temperature (centigrade degree -°C)
physiological parameter - measured with the use of a electronic thermometer
Measured: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
heart rate (min. / pulse)
physiological parameter - beats per minute
Measured: from the first 5th minute to the 6th hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
systolic and diastolic blood pressure (mmHg)
physiological parameter - measured with the use of a blood-pressure monitor
Measured: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
back pain
Visual Analog Scale (VAS) for pain- score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable".
Measured: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
Bleeding (present or absent)
vascular complication:(a) dressing contaminant, (b) pressure required, (c) dressing contaminant + pressure required, and (d) blood transfusion required
Measured: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
hematoma (cm)
vascular complication: 5 centimeters (cm) to greater hematoma, major hematoma; Less than 5 cm hematoma, minor hematoma
Measured: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
Ecchymosis
vascular complication: blue-violet coloration of the skin as a result of subcutaneous tissue bleeding
Measured: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study startJul 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Model description
- Randomized-controlled quasi experimental study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SELDA MERT, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611933
- Sponsor's protocol ID
- 16214662/050.01.04/85
- Status last verified
- Mar 2024
- First submitted
- 9 Jul 2018
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mert Boga S, Oztekin SD. The effect of position change on vital signs, back pain and vascular complications following percutaneous coronary intervention. J Clin Nurs. 2019 Apr;28(7-8):1135-1147. doi: 10.1111/jocn.14704. Epub 2018 Nov 22.
PubMed 30367542
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Position Change on Vital Signs, Back Pain and, Vascular Complications Following Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03611933
- Acronym / sponsor ID
- 16214662/050.01.04/85
- Keywords
- Back pain, patient positioning, vascular complications, vital signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Aug 2018 (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.
Aims and objectives: To determine the effect of position change that is applied after percutaneous coronary intervention on vital signs, back pain, and vascular complications.
Background: In order to minimize the post-procedure complications, patients are restricted to prolonged bed rest that is always accompanied by back pain and and hemodynamic instability.
Design: Randomized-controlled quasi experimental study Methods: The study sample chosen for this study included 200 patients who visited a hospital in Turkey between July 2014 and November 2014. Patients were divided into two groups by randomization. Patients in the control group (CG, n = 100) were put in a supine position, in which the head of the bed (HOB) was elevated to 15°, the patient's leg on the side of the intervention was kept straight and immobile; positional change was applied to patients in the experimental group (EG, n = 100).
Detailed description
Percutaneous coronary intervention (PCI) is an interventional procedure used to diagnose and treat chronic coronary artery disease. The recommended period of bed rest following a PCI is reported by Rolley et al. (2011) as being 2-4 hours (h). According to evidence-based guidelines in relevant literature, however, the bed rest was reported from 2-24 h; in these instances the supine position (SP) was used, which leads to movement limitation.
Among the patient-care goals during the post-procedural period, sustaining tissue perfusion and heart and vascular system operation, regulating vital signs, reducing pain, and supporting movement are important. According to such a procedure, the nurse's independent role is to provide the safest position for the patient, thereby positively affecting vital signs after PCI and reducing vascular complications and back pain.
Recently, similar nursing studies have reported the effect of position change after PCI on back pain, as well as vascular complications after PCI, the effect of position change on certain vital signs and vascular complications, the effect of position change regarding pain, patient comfort and certain vital signs, and the effect of positional change on intervention pain and all vital signs. Some studies have also looked into the effect of positional changes on back pain, certain vital signs, and vascular complication.
Prolonged bed rest in a SP has become tradition, but it can have negative effects. Comprehensive studies in the existing literature that can be applied to the post-PCI nursing care process-and which study the effect of the most reliable positional change on all vital signs, vascular complications, and, back pain-display a numerical inadequacy. Consequently, the authors intend the current study to be an experimental investigation of the effect of position change on vital signs, vascular complications, and back pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized-controlled quasi experimental study
| Arm | Type | Receives |
|---|---|---|
| Control group (CG) | No intervention | –Patients in the CG were provided with routine nursing care, as practiced in the clinic, including restricted bed rest. For this purpose, patients were given supine position in which the HOB was elevated 15° for 6-10 h; the patient's leg on the of the side of intervention was kept straight. |
| Experimental group (EG) | Experimental | Other: position change applied at different timesPatients in the EG were applied position changes between the first minute and sixth hour. During the initial six hours a supportive, thin pillow, 4 x 40 x 100 cm in size, was placed between the patient's shoulders and gluteals; this reduced the pressure on local tissues and muscle groups. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years of age
- a 6-7 F catheter
- must be able to lie in a supine position (without breathing problems)
- must be in balance hemodynamically
Key exclusion criteria (12 listed)
- hypotension
- hyperthermia or hypothermia
- no procedure except for PCI
- coagulation disorder
- decompensated heart failure
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 applied at different timesTime 1 - in the first fifth minute after the procedure supine position in which the HOB was elevated 15° Time 2 - in the first hour low fowler's position were given in which the HOB was elevated 15-30° Time 3 - in the third hour semi high fowler's position were given in which the HOB was elevated 30-45° Time 4 - in the fourth hour left or right lateral position were given in which the HOB was elevated 15° Time 5 - in the fifth hour low fowler's position were given in which the HOB was elevated 15-30° Time 6 - in the sixth hour standard fowler's position were given in which the HOB was elevated 45-60° | Other | Experimental group (EG) |
Primary outcome
Respiratory rate (respiratory rate / min.)
Time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
physiological parameter - rate per minute
body temperature (centigrade degree -°C)
Time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
physiological parameter - measured with the use of a electronic thermometer
heart rate (min. / pulse)
Time frame: from the first 5th minute to the 6th hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
physiological parameter - beats per minute
systolic and diastolic blood pressure (mmHg)
Time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
physiological parameter - measured with the use of a blood-pressure monitor
back pain
Time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
Visual Analog Scale (VAS) for pain- score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable".
Bleeding (present or absent)
Time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
vascular complication:(a) dressing contaminant, (b) pressure required, (c) dressing contaminant + pressure required, and (d) blood transfusion required
hematoma (cm)
Time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
vascular complication: 5 centimeters (cm) to greater hematoma, major hematoma; Less than 5 cm hematoma, minor hematoma
Ecchymosis
Time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention
vascular complication: blue-violet coloration of the skin as a result of subcutaneous tissue bleeding
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 Mar 2024.
- Results publication: PubMed 30367542Mert Boga S, Oztekin SD. The effect of position change on vital signs, back pain and vascular complications following percutaneous coronary intervention. J Clin Nurs. 2019 Apr;28(7-8):1135-1147. doi: 10.1111/jocn.14704. Epub 2018 Nov 22.
- PubmedLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing position change applied at different times in people with Percutaneous Coronary Intervention and Coronary Artery Disease, run by Kocaeli University.
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 4 inclusion and 12 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Respiratory rate (respiratory rate / min.) (time frame: The time from the first 5 minutes to the end of the sixth hour from the first 5th minute to the 6th hour after Percutaneous Coronary Intervention). The study lists 8 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 NCT03611933, which also lists 1 linked publication.
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 Mar 2024.