http://doi.org/10.33698/NRF0067 Narinder Kaur, Sukhpal Kaur, Yash Paul Sharma
Abstract : Incidence of coronary artery disease is increasing in the world over. Percutaneous coronary intervention procedure is fast becoming a tool of choice both for diagnosis and treatment. However the incidence of the vascular complications after sheath removal following percutaneous cardiac angiography vary widely with the compression method used to achieve femoral artery hemostasis. The present quasi experimental study was undertaken with an objective to compare two types of compression methods (Manual and ‘C’ Clamp) in terms of patient’s comfort and prevention of vascular complications. A total of 106 subjects undergoing coronary angiography were taken up for the present study. Fifty three subjects in each group were given compression either manually or through ‘C’ Clamp. Assessment of comfort level was done immediately after bleeding stopped in a 0- 10 numerical rating scale. The groin area was assessed for any vascular complications (Hematoma, ecchymosis and oozing) immediately after the bleeding stopped and at 12 hours/ removal of dressing. The mean time taken to stop the bleeding with ‘C’ Clamp was significantly higher than the Manual compression. (t=7.69, p<0.001) A comparison of mean comfort level and vascular complications showed that there was no significant difference in either group.
Key words :Comfort level, Hematoma, Ecchymosis, Oozing, ‘C’ Clamp compression, Manual compressions, Cardiac Angiography.
Correspondence at : Narinder Kaur
N. 113, Sector 38-A, Chandigarh narinder_120kaur@hotmail.com
Introduction
Coronary Artery Disease (CAD) is narrowing of blood vessels that supply blood and oxygen to the heart. As coronary arteries get narrower, blood flow to the heart gets slow or can even stop resulting in chest pain and shortness of breath.1 Various tests used to diagnose coronary hear t diseases are blood lipid profile, electrocardiogram (ECG or EKG), exercise stress tests, echocardiography, cardiac angiography etc.1,2 Cardiac angiography is the commonest diagnostic procedure for the diagnosis of cardiac ailments. It helps to identify the artery or arteries involved in cardiac disorders. It also provides critical information for taking decision regarding treatment modalities.1, 2 Various routes used for the cardiac angiography are femoral, brachial and radial arteries. However the femoral is the artery commonly used route for cardiac angiography. 3,4 After the procedure following the removal of catheter to attain hemostasis several methods are currently in use or under investigation, ranging from Manual compression to Closure technologies like the Vasoseal device, Collagen plugs, Femostop, Percutaneous Suturing devices and the Duett device etc.3,4,5 However the commonly used techniques are Manual compression and the ‘C’ Clamp. Though the ‘C’ Clamp compression has gained widespread acceptance, few studies have compared it to manual compression methods. 4 Chlan had conducted a study to compare Manual, ‘C’ Clamp and Femostop compression methods with respect to patients discomfor t, distress and vascular complications following a percutaneous coronary intervention procedure. No significant differences were found in terms of discomfor t, distress or vascular complications.4 In a study by Prack JB on the effect of Manual and ‘C’ Clamp, it has been reported that the incidence of hematoma and ecchymosis were >30% in each group. Overall 59% of patients were affected by either hematoma or ecchymosis, with 13% sustaining both complications.Only 1% of the patients manifested ischemic pain and numbness in the leg with ‘C’ Clamp compression method.6 Another study was carried out to compare the effect of Manual Compression, ‘C’ Clamp compression and Pneumatic Compression device for vascular homeostasis. The author repor ted that pneumatic compression has taken longer compression time and lead to greater discomfor t, more bleeding and larger hematomas, although the difference between Manual and ‘C’ Clamp was subtle in terms of hemostasis at the catheter puncture site. But the authors drew a conclusion that the result tends to favor the Manual method. 7 The primary role of the nurse for patient undergoing angiography is to monitor and prevent vascular complications and to promote comfort. Femoral catheter removal and compression of the puncture site to achieve hemostasis of the femoral artery following cardiac angiography is a medically delegated nursing responsibility.4 The purpose of the present study is to determine which of the two compression methods (Manual vs. ‘C’ Clamp) leads to more comfort level and results in lesser vascular complications.
Materials and Methods :The study was conducted in Cardiac Catheterization Lab, Coronary Care Unit and Cardiothoracic Unit, Nehru Hospital, PGIMER,Chandigarh. A total of 106 subjects with 53 each in Manual and ‘C’ Clamp group were taken up for the study. The concepts of the study were based on the Betty Neumann’s theory.8 Data was collected by using interview schedule and assessment Performa. A numerical rating scale was used to assess the level of comfor t immediately after each compression method at the catheter puncture site. It was represented on a line showing 0 to 10 score, where 0 indicates uncomfor table and 10 indicates highly comfortable. This scale was used immediately after completing each compression at the catheter puncture site in cardiac catheterization lab only. Assessments of vascular complications (Hematoma, Ecchymosis and Oozing) at the catheter puncture site was done immediately after the bleeding was stopped and at 12 hour /after removal of dressing. A scale (cm) was used to measure the size of hematoma and ecchymosis. The maximum length and breadth of hematoma and ecchymosis was multiplied to get the area of each. The ecchymosis was considered as large if it was >10cm2, medium if it was between 6-10cm,2 small ecchymosis if it was between1-5cm2 and no ecchymosis as 0cm.2 Hematoma was considered as large if it was >10cm2, medium if it was between 6-10 cm2 and small hematoma if it was between 1-5cm,2 and if it was 0cm2 then as no hematoma. Measurement of Oozing was carried out by observing the dressing i.e. fully soaked with blood, moderately soaked with blood and dry. Oozing was observed only after 12 hr/after the removal of the dressing.
Results : The mean age of the subjects in manual group and in ‘C’ Clamp compression group was 54.0yrs + 14.0 and 51.5yrs +12.25 with the range between 20-80 years and 20- 79 years respectively. Majority of the subjects i.e. 73.6% in Manual and 86.8% in ‘C’ Clamp group were males. Both the groups were comparable as per their age and gender. (Table 1)
Table – 1 : Demographic characteristics of the subjects
| Demographic characteristics | Manual (n=53) | ‘C’ Clamp (n=53) |
| Age
Mean + SD Range |
54.0yrs+ 14.0 20-80 |
51.5yrs +12.25 20-79 |
| Gender
Male Female |
39 (73.6%) 14 (26.4%) |
46 (86.8%) 07 (13.2%) |
The comfort level of the subjects was categorized into ‘uncomfortable’ ‘moderately uncomfortable’ and highly comfortable. Two third subjects i.e. 67.9% with Manual compression and 56.7%with ‘C’ Clamp compression were in the category of highly
Table – 2 : Comfort level of the subjectsn comfortable. The mean comfort level of the patients with Manual compression was 7.6±2.1 and with the ‘C’ Clamp compression it was 6.3±2.4.The difference was not statistically significant. ( x2 = 1.00, df =1, NS*). (Table 2)
|
Comfort Level |
Manual Compression (n=53) | C’ Clamp compression | ||||
| (n=53) | ||||||
| f | % age | f | %age | |||
| Uncomfortable (0-3) ** | 03 | 5.7 | 05 | 9.4 | ||
| Moderately
uncomfortable (4-7) ** |
14 |
26.4 |
18 |
33.9 |
||
| Highly comfortable (8-10) | 36 | 67.9 | 30 | 56.7 | ||
| Mean±SD Range | 7.6±2.1
0-10 |
6.3± 2.4
0-10 |
||||
| X2 = 1.00, df =1**, NS* | ||||||
*Not Significant
* *Uncomfortable and moderately uncomfortable groups are merged to apply x2 tests. The mean time taken to stop the bleeding with ‘C’ Clamp was 21.22min±5.13 and it was 13.68min±4.97 with the Manual compression. The time taken to stop bleeding with Manual compression was significantly less than with the ‘C’ Clamp. (t=7.69, df =104, p<0.001) (table-3) Seventy three percent subjects in the Manual group and 71.8% in ‘C’ Clamp group did not develop hematoma immediately after the compression. However after 12 hours of compression the percentage of the subjects increased to 79.2% in the Manual group and 90.5% in ‘C’ Clamp group who did not develop hematoma.
Table – 3 : Time taken (minutes) to stop bleeding at catheter puncture site
| N=106 | |||
| Time duration | Manual | ‘C’ Clamp | |
| (minutes) | (n =53) | (n =53) | |
| 10 | 30 | 01 | |
| 15 | 12 | 11 | |
| 20 | 06 | 21 | |
| 25 | 05 | 16 | |
| 30 | – | 03 | |
| 40 | – | 01 | |
| Mean ± SD | t | df p value | |
| Manual | 13.68±4.97 | ||
| ‘C’ Clamp | 21.22±5.13 | 7.69 | 104 p<0.001 |
The percentage of the subjects who developed hematoma was 26.3% with the Manual compression and 28.2% with the ‘C’ Clamp compression immediately after the compression. After 12 hours of compression the number of patients who developed hematoma decreased to 1.9% in the Manual group and 9.5% in the ‘C’ Clamp group though the difference was not statistically significant. The hematoma in each group was categorized as large, medium and small. There was an equal number of subjects (11.3%) in both the groups who developed large hematoma immediately. At 12 hours 5.7% in Manual group and 1.9% in ‘C’ Clamp group developed large hematoma. Immediately after the compression the mean size of hematoma was 3.28 ± 8.39 cm2 and 2.58±6.26 cm2 with the Manual and ‘C Clamp compression respectively. However after 12 hours of compression, the mean size of hematoma was 1.55± 5.13 cm2 and 1.19± 6.64 cm2 in Manual and ‘C’ Clamp group respectively. The measurement of hematoma was done with a ruler scale in cm2 (Table 4). i.e., by multiplying the maximum length and maximum breath of hematoma.
| formation | Manual | ‘C’Clamp x2 Manual ‘C’Clamp x2 | ||||
| n (%) | n (%) | n(%) | n(%) | |||
| No | 39 (73.7) | 38 (71.8) | 0.95 | 42 (79.2) | 48 (90.5) | 2.6 |
| Yes
Size of hematoma |
14(26.3) | 15 (28.2) | df =1 NS* | 11 (20.8) | 5(9.5) | df=1 NS* |
| · Large(>10 cm2) | 6 (11.3) | 6 (11.3) | 3 (5.7) | 1 (1.9) | ||
| · Medium(6-10cm2) | 3 (5.6) | 1 (1.9) | 2 (3.8) | 1 (1.9) | ||
| · Small (1-5cm2) | 5 (9.4) | 8 (15.0) | 6 (11.3) | 3 (5.7) | ||
| Mean ±SD (cm2) | 3.28±8.39 | 2.58±6.26 | 1.55±5.13 | 1.19± 6.64 | ||
| Range | 0-40 | 0-24 | 0-32 | 0-48 | ||
Table 5 depicts that 81.1% subjects with the Manual compression and 83.0% with the ‘C’ Clamp compression did not develop ecchymosis immediately after the compression. However 62.3% subjects in the Manual group and 47.2% in ‘C’ Clamp group did not develop ecchymosis, 12 hours after compression method. The total number of the subjects who developed ecchymosis immediately after the compression method were 18.9% and 17% with Manual and ‘C’ Clamp compression respectively. Whereas 37.7% in Manual group and 52.8% in ‘C’ Clamp group developed ecchymosis after 12hours of the compression. There was no statistically significant difference in the formation of ecchymosis between both the groups. The subjects who developed ecchymosis were categorized as large, medium and small.15.1% subjects with the Manual compression and 13.2% with ‘C’ Clamp developed large ecchymosis after 12 hours of the compression. The mean size of ecchymosis was 4.68±9.33 cm2 and 6.75±13.54 cm2 in the Manual and ‘C’ Clamp compression respectively after 12 hours of compression.
Table – 5 : Post compression ecchymosis among the subjects N=106
Immediately after the of 12 hours after the compression
Ecchymosis compression
formation Manual ‘C’Clamp x2 Manual ‘C’Clamp x2
| n (%) | n (%) | n(%) | n(%) | ||
| No | 43 (81.1) | 44 (83.0) | 0.62 33 (62.3) | 25 (47.2) | 3.73 |
| Yes
Size of ecchymosis |
10 (18.9) | 09 (18.0) | df= 1 20 (37.7) NS | 28 (52.8) | df = 1 NS |
| · Large (>10 cm2) | 01 (1.9) | 2 (3.8) | 08 (15.1) | 07 (13.2) | |
| · Medium(6-10cm2) | 01 (1.9) | 1 (1.9) | 07 (13.2) | 11 (20.7) | |
| · Small (1-5cm2) | 08 (15.1) | 6 (11.3) | 05 (9.4) | 10 (18.9) | |
| Mean ±SD (cm2) | 1.21±5.55 | 0.89±2.59 | 4.68±9.33 | 6.75±13.54 | |
| Range | 0-40 | 0-13 | 0-60 | 0-65 |
Discussion Vascular access site complications are among the most frequent cause of morbidity after percutaneous cardiac catheterization procedures. Despite the advances in technology of coronary intervention, access site management has changed little over the years. The recent ostly and are an added burden on the poor patients in countries like India. Therefore Manual and ‘C’ Clamp compressions continue to be used in our country. Assessment and management of vascular complications are important nursing responsibilities for patients undergoing cardiac angiography. The objective of the present study was to determine the effect of two compression methods (Manual and ‘C’Clamp) after catheter removal with respect to patient’s comfort level and the occurrence of vascular complications.Coronary artery disease is the disorder of middle adulthood and of the older population. It has also been documented that it is more prevalent in males.2 Moreover congenital hear t diseases may require angiography at a very young age.In the present study the mean age of subjects was 54 yrs ±14.0 with the range between 20-80 yrs in Manual group and in the ‘C’ clamp group it was 51.5yrs ±12.5 with the range between 20-79 yrs. The majority of subjects (34%) were male. Chlan LL studied the effect of Manual and ‘C’ Clamp with respect to vascular complication, discomfort and distress. In his study the mean age of subjects was 62.3±1.4 with a range between 33-90 yrs. The majority (77%) of subjects were male.4 Following the cardiac angiography, after the removal of the catheter, prolonged pressure is to be applied at the site to stop bleeding and to prevent vascular complications. This prolonged pressure may be quite discomforting for the patients. In the present study the comfort level of the study subjects was assessed by using a 0-10 numerical rating scale. It was observed that the mean comfort level of the subjects with manual compression was more (7.6 + 2.1) than the subjects with ‘C’ clamp compression (6.3±2.4), though the difference was not statistically significant. Lehmann has reported the mean level of discomfort as 1.9±1.9 in the patients of Manual group and of 2.2±2.0 for the patient in the ‘C’ Clamp group.3 In the present study, time taken (minutes) to stop the bleeding was significantly less (13.68±4.97) in the subjects with Manual compression than the subjects with ‘C’ Clamp compression (21.22±5.13). The findings have been supported by the result of Selmer’s study in which it has been reported that mean compression time was 19.9min versus 33.5min in the Manual and ‘C’ Clamp group respectively. Though the time taken in Selmer’s study to stop the bleeding is more in both the groups. 7 Another study conducted by Simon, reported a longer mean compression time and no difference in complication rates with the ‘C’ Clamp and Manual method in a 200 patient’s retrospective study. 9 The complications in the present study such as hematoma, ecchymosis and oozing were assessed immediately and 12 hours after each compression. Maximum number of subjects i.e. 73.3% and 71.8% in Manual and ‘C’ Clamp group respectively did not develop hematoma immediately. However at 12 hrs there was 79.2% subjects in Manual group and 90.5% with ‘C’ Clamp group did not developed hematoma.The percentage of the subjects who developed hematoma was 26.3% with the Manual compression and 28.2% with ‘C’ Clamp group immediately after the compression. After 12 hours of compression the number of subjects who developed hematoma decreased to 1.9% in the Manual group and 9.5% in the ‘C’ Clamp group though the difference was not statistically significant. The mean size of hematoma in Manual group was 3.28±8.39 cm2 and 1.55±5.13 cm2 immediately and 12 hrs respectively after the compression. In ‘C’ clamp compression it was (2.58±6.26 cm2 and 1.19±6.64 cm2) immediately and at 12 hours after compression respectively. Equal number of subjects had large hematoma i.e. 11.3% in both the groups. The majority of subjects i.e. 81.1% with the Manual compression and 83.0% with the ‘C’ Clamp compression did not develop ecchymosis immediately after the compression. However 62.3% subjects in the Manual group and 47.2% in ‘C’ Clamp group did not develop ecchymosis 12 hours after compression method. The total numbers of the subjects who developed ecchymosis immediately after the compression were 18.9% and 17% with Manual and ‘C’ Clamp compression respectively. Whereas 37.7% in Manual group and 52.8% in ‘C’ Clamp group developed ecchymosis after 12hours of the compression. There was no statistically significant difference in the formation of ecchymosis between the groups. Only 15.1% subjects with Manual compression and 13.2% with ‘C’ Clamp developed large ecchymosis, after 12 hours of the compression. The mean size of ecchymosis was 4.68±9.33 cm2 and 6.75±13.54 cm2 in the Manual and ‘C’ Clamp compression respectively after 12 hours of compression.In the other studies also the ecchymosis size reported to be increased in ‘C’ clamp group after 12hours of the compression method. The size of ecchymosis was more in ‘C’ clamp group as compared to Manual group. It has been also observed that the size of ecchymosis was increased after the 12 hours of compression method. Whereas Manual group had opposite results. 4,5,7 There was no subject in either group who had oozing after 12 hours of compression / after removal of dressing.In current study an increase in size of ecchymosis among the subjects who were given compression with ‘C’ clamp as compared to Manual compression after 12 hours was noted whereas in other studies also an increase in the ecchymosis has also been reported with use of ‘C’ clamp after 12hours of the compression.4, 5,7.Based on the finding of present study it can be recommended that both the methods of compression can be continued after the removal of catheter for the patients undergoing cardiac angiography to promote comfort level and prevention of vascular complications. A similar study can be conducted to assess the vascular complications at the catheter puncture site after 24 hours and 48 hours. A similar study can be conducted on larger sample for the generalization of the findings
References
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- Smeltzer SC, Bare Brunner and Suddhartha’s A Textbook of Medical-Surgical nursing. 8th ed. Philadelphia: Lippincott; 1996; 638.
- Lehmann KG, Samantha J. Randomized comparison of hemostasis techniques after invasion cardiovascular procedures. American Heart Journal 1999; 138(6): 1118-25.
- Chlan LL, Sabo J, Savik Effects of three groin compression methods on patien
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