Minimizing shortterm complications in patients who have undergone cardiac invasive procedure a randomized controlled trial involving position change and sandbag

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Slide 1 : Minimizing short-term complications in patients who haveundergone cardiac invasive procedure: a randomizedcontrolled trial involving position change and sandbag Emel Yilmaz, PhD, Cemil Gürgün, MD*, Alev Dramali, PhD** School of Nursing, Celal Bayar University, Manisa, Turkey *Department of Cardiology, Medical Faculty, Ege University, Izmir, Turkey **School of Nursing, Ege University, Izmir, Turkey
Slide 2 : Introduction Cardiac interventions have become a commonly accepted treatment option for patients with coronary heart disease. The majority of procedures are performed via a femoral approach. Coronary and peripheral angiography is associated with low but significant risk of the access site complications.
Slide 3 : The patient’s outcomes after removing of sheaths include vascular complications, such as bleeding, hematoma, distal embolization, pseudoaneurysm and arterial thrombosis and they are the most important vascular complications of coronary angiography.
Slide 4 : Because of the potential vascular complications, all patients had prolonged bed rest with restricted movement after the procedure in order to prevent bleeding from the femoral access site. However, several investigations have shown that patients reported several problems tolerating this immobility, such as discomfort and pain.
Slide 5 : The back pain is a common problem among patients after coronary angiography and is associated with immobility and restricted positioning. In addition, prolonged bed rest often delays hospital discharge and increases costs. Hospitals vary in the nursing policies concerning the length of bed rest after coronary arteriography via the femoral artery approach.
Slide 6 : The duration of bed rest post-procedure differs according to sheath size and local policy and may vary from 4 to 24 hours. However, suggested bed rest duration times vary, ranging from 2 to 6 hours. After the procedure of angiography and catheterization, early ambulation and reduction of the time patients remain in supine position and elevation of the head of bed between 30-60 degrees may significantly decrease patient’s discomfort and back pain after coronary angiography without increasing vascular complications. In this way, patients would have less discomfort, ambulate, and be discharged home earlier, staff would be deployed more efficiently, and throughput would be enhanced.
Slide 7 : That application of the weight of 2.3 kg- 4.5 kg (5-10 pound, 1 pound=454 gr) on femoral access site helped in reducing the bleeding has been shown in several studies. Sandbags have been placed over arteriotomy site. On the other hand, the effectiveness of sandbag application in preventing vascular complications has not been demonstrated Christensen et al and Juran et al. It was seen that application of a sandbag was unnecessary and there was no increase of vascular complications in the patients who were not applied a sandbag.
Slide 8 : Aim The aim of this study was to evaluate the effect of putting a sandbag on femoral access site after cardiac invasive procedure by changing patients’ position in bed on vascular complications rates and to determine severity of back pain related to bed rest duration after coronary angiography.
Slide 9 : Methods Patients Totally 340 patients were admitted to the Ege University Medical Faculty Cardiology department for coronary angiography and/or cardiac catheterization between 15.2.2004–15.5.2004. Overall, 169 (158 -undergoing coronary angiography, 11–undergoing coronary angiography and/or cardiac catheterization) patients were found eligible to participate in this randomized and controlled study.
Slide 10 : The exclusion criteria of the study were: Age below 18 years Non- femoral approach for the procedure History of treatment with thrombolytics and known bleeding disorder Experienced back pain and deep vein thrombosis before the procedure Systolic pressure >190 mmHg or diastolic pressure >110 mmHg
Slide 11 : Usage of the arterial sheath larger than 7-F size [7-F=the diameter of catheter (1 French (f)=0.33 mm)] Active bleeding in femoral access site before sheath removal Procedural complications such as hematoma, bleeding, and arrhythmias Unconsciousness Refusal from participation in the study.
Slide 12 : All patients were randomly (sealed envelope randomization) assigned into 5 groups in accordance with type of treatment initiated immediately after sheath removal and achieving adequate hemostasis - the application of sandbag of different weight and duration, and position changes:
Slide 13 : Group 1 - 35 patients whose positions were changed and a sandbag of 4.5 kg was applied for 30 minutes Group 2 - 35 patients whose positions were changed and a sandbag of 2.3 kg was applied for two hours Group 3 - 32 patients whose positions were not changed and a sandbag of 4.5 kg was applied for 30 minutes Group 4 - 34 patients whose positions were not changed and a sandbag of 2.3 kg was applied for two hours Group 5 - 33 patients who regularly remain supine position without changing position and who had no application of a sandbag.
Slide 14 : Ethical Consideration Ethical approval for the study was obtained from the Ethics Committee of the Nursing School of Ege University. The researcher explained the study to potential participants, and written informed consent was obtained. Anonymity and confidentiality were assured, and participants were told that they could withdraw from the study at any point without adverse effects on their subsequent care.
Slide 15 : Intervention Femoral arterial sheaths of 7-F size were used and sheaths were removed by an interventional cardiologist after the procedure. After sheath removal, hemostasis on the femoral access site was achieved by manual compression. When satisfactory hemostasis was achieved, sterile gauze sponges that have the dimension of 10x10 cm have been placed as the dressing material on the femoral access site.
Slide 16 : The access site was covered by sticking cloth plaster of 5 cm width in stripes of 30 cm length over sterile tampons. After the patients were taken into their beds, sandbags of 2.3 kg or 4.5 kg prepared by the researchers were applied to the femoral site. Sandbags were prepared in the dimension of 32 x 12 x 8 cm.
Slide 17 : Group 1 patients were applied a sandbag of 4.5 kg for 30 minutes and Group 2 patients received application of a sandbag of 2.3 kg for two hours. Group 1 and 2 patients’ positions were changed. Patients were turned to unaffected side at interval to decrease back pain from the second hour when they were taken into their beds and the head of the beds were raised about 30-45 degrees.
Slide 18 : Patients were repositioned hourly, alternating between supine, right side lying, and left side lying, remaining for 1 hour in each position, during the first 7 hours. During side lying, a pillow was placed at the lumbar area for support and the affected leg remained straight.
Slide 19 : Group 3 patients were applied a sandbag of 4.5 kg for 30 minutes and Group 4 patients received application of a sandbag of 2.3 kg for two hours. Group 3 and 4 patients’ positions were not changed. These patients received routine care with bed rest until next morning after the procedure and affected leg was immobilized during bed rest. Group 5 patients remained in supine position without changing position and had no application of a sandbag.
Slide 20 : All patients were mobilized next morning at 08:00. Five minutes prior to mobilization all patients were assisted to sit on the edge of the bed for five minutes to avoid possibility of postural hypotension. On mobilization, each patient was asked to walk around the ward and then observed. If no vascular complications were encountered patients were allowed to mobilize freely.
Slide 21 : Data Collecting Instruments Demographics and clinic characteristics were obtained by patient reports. The variables were listed in a record form: age, gender, body mass index (BMI), systolic blood pressure before and after the procedure measured at the bed unit, systolic blood pressure at the beginning and end of the procedure measured at the catheterization laboratory and the bed unit, drugs, sheath size, time of compression, time of bed rest, hospital stay time, clinical patient history, previous invasive procedure(s), presence of diabetes mellitus, renal disease, and peripheral arteriosclerosis.
Slide 22 : Pre-and postprocedural hemoglobin, hematocrit, prothrombin time (PT) and activated partial thromboplastin time (aPTT) were obtained in all patients. The independent clinical examinations were performed to determine the presence of bleeding, ecchymosis, hematoma and other vascular complications.
Slide 23 : The bleeding and hematoma in femoral access site were visually checked, when hematoma was recognized, its margin was marked by permanent ink pen and its size was measured by using millimetric measuring paper.
Slide 24 : Bleeding was described as any ooze, leaking or frank blunt drainage from the puncture site. Insignificant bleeding was defined as blood loss estimated as less than 100 mL. Significant bleeding was defined as blood loss estimated as equal or greater than 100 mL.
Slide 25 : Minor hematoma was defined as an accumulation of blood at skin level with a diameter of >5 cm in the area of the artery puncture. The subjective assessment of bleeding and hematoma was a routine assessment made by researcher and a doctor.
Slide 26 : Femoral puncture sites were assessed every 15 minutes for the first hour, then hourly for the following 6 hours. The final assessment was done the morning following the procedure at 08.00 hours.
Slide 27 : Patient’s vital signs and circulatory status were assessed (every 15 minute in first hour, 30 minutes in second hour, and then every hour during rest of the time). The participants were asked to describe their back pain and rate its severity by using the Visual analogue scale (VAS) (0=none, 10=severe pain) on immediate return the unit, and then after 2nd, 4th, 6th hour and the next morning at 8:00 AM.
Slide 28 : Visual analogue scale is a 10-cm straight horizontal line anchored at each end with descriptor terms representing the limits of the variable being measured (for pain intensity: no pain/worst pain possible). It has been used in clinical situations for many years and has been reported to be sensitive, valid and reliable. All values in the observation form after procedure were measured and filled by the researcher.
Slide 29 : Statistical Analysis Data were analyzed using the Statistical Package for Social Science (SPSS, version 10.0, Chicago, IL, USA, 1999). The sample size of the study was calculated with power of 80% and significance level of 5% according with the results of previous study. Patient`s demographic data were estimated as number and percentage.
Slide 30 : Chi-square test was used for analysis of discrete variables, while one-way ANOVA and Student t test were applied for analysis of continuous variables. For the ANOVA analysis, the post hoc comparisons were accomplished using Tukey HSD test. For determining relation among the variables, analysis of correlation was used. The level of significance was set at <0.05.
Slide 31 : Results
Slide 32 : Patient characteristics for the 169 patients studied are summarized in Table 1. There were no statistically significant differences in gender, age, BMI, history of hypertension, diabetes mellitus, hyperlipidemia, smoking, previous MI and antithrombotics drug utilization among the groups (p>0.05).
Slide 33 :
Slide 34 : No patient developed major hematoma in this study. In patients whose sandbag of 2.3 kg or 4.5 kg were applied for 30 minutes or two hours, active bleeding in 1 patient (0.7 %), minor hematoma in 12 patients (8.8 %), ecchymosis in 29 patients (21.3 %) and distal embolization in 1 patient (0.7 %) were observed. No statistical difference was found for complication between the groups (p>0.05) (Table 2).
Slide 35 :
Slide 36 : In patients whose positions were changed the following complications were observed: active bleeding in 1 patient (1.4 %), minor hematoma in 4 patients (5.7 %), ecchymosis in 11 patients (15.7 %) and distal embolization in 1 patient (1.4 %). There was no difference for complications between the groups (p>0.05) (Table 3).
Slide 37 :
Slide 38 : Table 4 shows that back pain increased with bed rest time during the first 6 hours after the procedure. Patients who were allowed to change position during the bed rest period (Group 1 and 2) experienced less back pain than patients who remained supine position (Group 3,4, and 5) during the bed rest.
Slide 39 : Back pain levels were statistically significantly different among the groups as five-time period (p<0.05). The VAS scores of patients who had the application of same period and same weight of sandbag but who didn’t change their positions were different than in the patients who changed their positions (p<0.05).
Slide 40 : Back pain in patients whose positions were not changed was observed to be more severe than in the patients whose positions were changed (p<0.05). No statistical difference was determined between the patients whose sandbag was applied but position was not changed (Group 3 and 4) and the patients who had no application of sandbag and remain in supine position (Group 5).
Slide 41 : Conclusion and Implications In conclusion, our study shows that the incidence of severe vascular complications in our patients does not exceed currently published rates. The study indicates that, sandbag was not effective in decreasing the incidence of the vascular complications suchas bleeding and hematoma after the diagnostic invasive procedures.
Slide 42 : Patients with a sandbag had an increased back pain. The study’s findings suggest that sandbag could not be recommended. Patients might safely change their positions in bed earlier, the head of bed should be raised about 30-45 degrees and the duration of bed rest should be shortened after the procedure.
Slide 43 : Changing position in bed may also, reduce back pain and promote physical comfort and reduce patients’ negative feelings toward coronary angiography. In addition to pain medication, other comfort measures such as back rubs may be required more frequently among patients following procedure to reduce back pain.
Slide 44 : When back pain of patient is lessened, the workload of health care workers could be reduced and consuming more analgesic of patient could be prevented. The early mobilization may lead to earlier discharge; additional costs can be moderated by providing the usage of patients’ beds more effectively.
Slide 45 : Results obtained in this study provide nurses with a better understanding of patients’ physical needs, so that appropriate nursing interventions can be planned to enhance patient comfort after cardiac intervention.
Slide 46 : Furthermore, the findings obtained provide nurses with the evidence for collaborating with physicians and healthcare providers, to modify existing post-coronary intervention protocols, to encourage early ambulation, and to enhance patient comfort. True collaboration involves equally valued contributions by different members of the health care team.
Slide 47 : This innovative nursing research project contributes to evidence-based nursing interventions, aimed at improving post procedures care in Turkey through protocol modification by collaboration with other health care team members.

 


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