A Randomized Controlled Trial on Position Change followed by early Ambulation after Trans-Femoral Coronary Angiography

 

Parisha Rai¹, Manju Dhandapani², Shiv Bagga³, L Gopichandran⁴, Yash Paul Sharma⁵

¹M Sc Cardiac Nursing, NINE, PGIMER. Lecturer, B & B Medical Institute, Gwarko, Lalitpur, Nepal.

²M. Sc Neuroscience Nursing, PhD Nursing, Lecturer, NINE, PGIMER, Chandigarh

³MD, DM, Assistant Professor, Department of Cardiology, PGIMER.

⁴M. Sc Cardiac-Nursing, Lecturer,PhD Nursing College of Nursing, All India Institute of Medical Sciences (AIIMS), New Delhi

⁵MD, DM, Professor and Head of Department of Cardiology, PGIMER.

 

ABSTRACT:

Background and Aim: Femoral route is a common approach for doing coronary angiography, but bed rest is recommended due to risk of vascular complications. The aim of present study was to assess effect of position change followed by early ambulation after coronary angiography via femoral approach on comfort, fatigue and vascular complications of the patients. Subjects and Methods: A randomized controlled trial was conducted on 80 patients (40 each in control and experimental group) undergoing coronary angiography in a tertiary care institute in India. Patients in control group were placed in supine position and ambulated after 6 hours. Experimental group were kept in supine position for 2 hours after angiography, followed by right lateral position (1 hour), supine position (1 hour) and ambulated after 4 hours. Kolcaba’s Outcome was assessed using General Comfort Questionnaire, Numerical pain rating scale and Fatigue Visual Numeric Scale at 2, 4, 6 and 24 hours after angiography. Incidence of vascular complications was documented at 24^th hours. Results: At 4^th and 6^th hours after angiography, fatigue experienced by experimental group was significantly lower than control group. At 6^th and 24^th hour, experimental group had significantly lesser back pain and better comfort. There was no significant difference in the incidence of vascular complications between the control and experimental groups. Conclusion: Position change followed by early ambulation after coronary angiography via femoral approach is safe and effective as it decreases back pain, fatigue and improve comfort without increasing vascular complications.

 

 

 

 

 

INTRODUCTION:

Cardiovascular diseases are significant since they are among the most common chronic diseases of the 21^st century and are regarded as the main cause of disabilities and deaths all over the world¹. With the cases of cardiovascular diseases increasing on the toll, coronary angiography is the most sought-after procedure for early diagnosis and treatment. Due to increased risk of vascular complications after coronary angiography via femoral route, bed rest is recommended for the patients but the duration of bed rest that follows after the procedure is still unclear.

 

Researchers have supported the efficacy of 6 hours of bed rest after coronary angiography via femoral route^2-8. Providing various positions to the patients during bed rest has also shown to be effective in reducing the back pain and improving the comfort of the patients without having a major impact on the vascular complications^2-5,9-11. Effectiveness of early ambulation after angiography via femoral access on pain and vascular complications are reported by many authors^4,12-14. However, very little evidence is available on whether combining position change and early ambulation has a good impact on the patients in terms of comfort and vascular complications^15,16. Therefore, the present study aimed to suitably position the patients during the complete rest, decrease the duration of complete rest, provide patients with more comfort and reduce the fatigue encompassing an overall safe ambulation protocol without increasing the probable vascular complications.

 

MATERIALS AND METHODS:

This randomized controlled trial was conducted at a single tertiary hospital. A total of 80 patients (40 each in control and experimental group) were enrolled in the study during period of data collection after meeting the inclusion criteria which included the patients being conscious and more than 18years of age. Patient were excluded from the study if they had emergency/ urgent cardiac intervention, known bleeding disorders, development of complications during the procedure such as arrhythmia and unconsciousness, physical disability, chronic back pain or previous thrombolytic treatment within 10 days of procedure. Patients were randomized using computer generated random table. Ethical approval was obtained from the Ethicsl Committee of the institution (reference number NK/1374/M.Sc/354). The study was also registered under the ICMR (Indian Council of Medical Research) with CTRI no. CTRI/2015/01/005369.

 

The control group received the routine care after angiography in which the patients were kept in supine position for 6 hours and then finally ambulated 6 hours after angiography. In the experimental group, patients were kept in the supine position for 2 hours after angiography, followed by right lateral position for 1 hour and then back to supine position for an hour. Then they were ambulated 4 hours after angiography.

 

Pain, Comfort level and fatigue were assessed 2, 4, 6 & 24 hours after angiography. Assessment of back pain score was done by Numerical pain rating scale, a standard diagnostic tool provided by the National Initiative on Pain Control (NIPC)¹⁷. It is represented on a line showing 0 to 10 score where 0 score indicates no pain and 10 score indicates worst pain as shown in Figure 1. Assessment of comfort score: A modified tool adapted from the original Kolcaba’s General Comfort Questionnaire was used to assess the level of comfort¹⁸. Permission to alter the original questionnaire was sought from the concerned authority. The possible scores ranged from 5-24, with higher score indicating higher comfort level. Fatigue was assessed using Visual Numeric Scale¹⁹. The scale is represented on a line showing 0 to 10 score where 0 indicates no fatigue and 10 indicates severe fatigue as illustrated in Figure 2.

 

Figure 1: Fatigue Visual Numeric Scale

 

Vascular complications such as hematoma, bleeding and ecchymosis were assessed 24 hours after angiography. The hematoma was first palpated and the edges of the hematoma were measured with the help of a ruler. Similarly, the widest diameter of the ecchymosis was identified and measured with the help of a ruler. Bleeding was assessed in terms of fully soaked dressing, moderately soaked dressing and dry dressing.

 

Data was analyzed using SPSS (Statistical Package for Social Sciences) 20 version. Chi-square test and Mann Whitney test were applied to determine the level of significance at p<0.05.

 

 

RESULTS:

Sample characteristics:

Table 1: Socio-demographic Profile of the Patients                  n= 80

Variable		Control group (n1=40) f (%)	Experimental group (n2=40) f (%)	ᵪ2 or t value (df) p value
Age (years)	Mean ± SD	56.7 ± 14.16	52.92 ± 13.63	1.21 (78) 0.23
Sex	Male	31 (77.5)	26 (65)	1.53 (1) 0.22
	Female	9 (22.5)	14 (35)
Marital status	Married	37 (92.5)	34 (85)	0.50 (1) 0.48#
	Unmarried/ widow/widower	3 (7.5)	6 (15)
Occupation	Employed	26 (65)	17 (42.5)	4.56 (2) 0.10
	Unemployed	9 (22.5)	12 (30)
	Retired	5 (12.5)	11 (27.5)
Per capita income (Rs./ month)	Mean ± SD	3194.25 ± 2534	2618.4 ± 1464.51	1.24 (78) 0.22

^# = Fischer’s Exact test

 

Table 2 Clinical Profile of the Patients n= 80

Variable		Control group (n1=40) f (%)	Experimental group (n2=40) f (%)	ᵪ2(df) p value
Diagnosis	Coronary artery disease	31 (77.5)	23 (57.5)	3.65 (1) 0.06
	Others (Rheumatic heart disease, Congenital heart defects, Dilated cardiomyopathy, Atypical chest pain)	9 (22.5)	17 (42.5)
Coexisting condition	None	16 (40)	19 (47.5)	0.52 (2) 0.77
	Hypertension	10 (25)	8 (20)
	Others (Diabetes mellitus, Renal failure, Hypothyroidism, Cholelithiasis)	14 (35)	13 (32.5)
Tab. Aspirin	No dose	17 (42.5)	22 (55)	1.32 (2) 0.52
	75mg	8 (20)	7 (17.5)
	150mg	15 (37.5)	11 (27.5)
Tab. Clopidogrel	No dose	18 (45)	23 (57.5)	0.26#
	75-150mg	19 (40)	12 (30)
	300-600mg	3 (5)	5 (12.5)

^# = Fischer’s test

 

 

Table 3: Angiography Details and Laboratory Investigations of the Patients n= 80

Variable		Control group (n1=40) f (%)	Experimental group (n2=40) f (%)	ᵪ2 or t value (df) p value
Previous history of angiography		10 (25)	10                   (25)	0 (1), 1.0
Angiography finding	Normal	19 (47.5)	21 (52.5)	0.09#
	Single Vessel Disease	5 (12.5)	11 (27.5)
	Double Vessel Disease	4 (10)	4 (10)
	Triple Vessel Disease	12 (30)	4 (10)
		Mean ± SD	Mean ± SD
Hemoglobin (gm/dl)		12.58 ± 1.39	12.4 ± 2.24	0.42 (78), 0.68
Platelet count (per mm3)		2,04,100 ± 50016.3	2,06,750 ± 53381.4	0.23 (78), 0.82
Duration of angiography (min) Mean ± SD		28 ± 12.7	26.50 ± 10.45	0.58 (78), 0.57

^# = Fischer’s Exact test

 

 

 

Table 4: Severity of Back Pain at Different Observations   n = 80

Back pain assessment	Control group (n1=40) Median (IQR)	Experimental group(n2=40) Median (IQR)	Mann-Whitney Test p value
2nd hour	1 (0 to 2)	2 (0 to 4)	0.11
4th hour	3 (2 to 5)	2 (1 to 4.5)	0.29
6th hour	4 (3 to 8)	1 (0 to 2)	<0.001*
24th hour	0 (0 to 2)	0 (0 to 0.75)	0.03*

* = Significant at <0.05

 

Both the groups are comparable as per their sociodemographic and clinical profile (p>0.05) as depicted in Table 1 and 2. More than three-fourth of the patients (77.5%) in the control group and more than half of the patients (56.5%) in the experimental group were diagnosed with CAD. Majority of the patients had normal weight (BMI: 18.5-24.9 kg/m²).

 

Table 3 illustrates the angiography details and laboratory investigations of the patients. Chi-square test and Fischer’s Exact test showed that both the groups are homogenous (p>0.05).

 

It was observed that back pain was significantly lower in experimental group as compared to the control group at 6^th hour (p<0.001) and 24^th hour after angiography as shown in table 4. This implies that position change followed by early ambulation significantly reduces severity of back pain of the patients.

 

 

Table 5: Comfort Score of the Patients at Different Observations

n = 80

Comfort score assessment	Control group (n1=40) Median (IQR)	Experimental group (n2=40) Median (IQR)	Mann-Whitney Test p value
2nd hour	17.5 (16 to 18)	16 (14 to 18)	0.01
4th hour	15 (13 to 16)	15 (13 to 17)	0.40
6th hour	12 (11 to 14)	20 (18.25 to 21)	<0.001*
24th hour	22 (21 to 22)	24 (23 to 24)	<0.001*

* = Significant at <0.05

 

Table 5 illustrates the assessment of comfort score of the patients at different observations. At the 4^th hour, a gradual decrease in comfort score was seen in both the groups but the difference between the groups was not statistically significant. Assessment at 6^th and 24^th hour showed that the experimental group had a significantly lower median comfort score (p<0.001) as compared to the control group. This suggests that position change followed by early ambulation significantly improves the comfort level of the patients.

 

Table 6: Fatigue Score among the Patients at Different Observations

n= 80

Fatigue assessment	Control group (n1=40) Median (IQR)	Experimental group(n2=40) Median (IQR)	Mann-Whitney Test p value
2nd hour	1 (0 to 2)	2 (0 to 3)	0.96
4th hour	3 (2 to 5)	2 (0.25 to 3)	0.03*
6th hour	4 (3 to 8)	1 (0 to 2)	<0.001*
24th hour	0.5 (0 to 2)	0 (0 to 1)	0.06

* = Significant at <0.05

 

Table 6 describes the fatigue score among the patients at different observations in both the groups. At 4^th and 6^th hour, fatigue experienced by experimental group was significantly lower than the control group. This indicates that position change followed by early ambulation significantly decreases the fatigue of the patients.

 

Table 7: Comparison of Patient Outcome in terms of Vascular Complications                          n= 80

Vascular complications	Control group (n1=40) f (%)	Experimental group (n2=40) f (%)	c2 (df) p value
Hematoma	1 (2.5)	3 (7.5)	0.26 (1) 0.61
Ecchymosis	14 (35)	8 (20)	2.26 (1) 0.13
Bleeding	3 (7.5)	2 (5)	0.0 (1) 1.0#

^# = Fischer’s test       

 

As displayed in table 7 there was no significant difference in the incidence of vascular complications between the control and experimental groups (p>0.05).

 

DISCUSSION:

Irrespective of various etio-pathogenesis, vascular diseases remain to be the leading cause of death and disability globally^20-22. Present study was conducted to assess the effectiveness of position change followed by early ambulation on comfort, pain and vascular complications of patients undergoing coronary angiography via femoral access. Results of the present study showed that position change followed by early ambulation (four hours) after coronary angiography reduced back pain, enhanced comfort and decreased fatigue.

 

Strict bed rest after coronary angiography via the femoral approach is routinely advised. The most preferred position is supine position for six hours but recent studies have implemented various modified position change during the first 6-8 hours after angiography. This includes changing the position of the patients hourly varying between supine, right side lying and left side lying^2,8-10, changing the position of the patients each hour into supine, semi-Fowler’s up to 30° and elevated up to 45° or providing intermittent changes to the patient’s body and head position in bed^8,23. Similar to present study findings, all these studies demonstrated that position change during bed rest after coronary angiography reduces back pain and promotes comfort without increasing the vascular complications. Similar to present study findings, Rezaei-Adaryani et al (2008) found that intermittently changing the patients' position was associated with an increased comfort and decreased fatigue without increasing the amount of bleeding and hematoma. It is reported in the literature that ambulating patients four hours after coronary angiography via the femoral route is safe and do not increase the vascular complications^5,6,12,16 especially bleeding, but may reduce back pain^16,24. The results of these studies chime in with those of the current study. Some studies have incorporated the effect of modified positioning with early ambulation. Pooler-Lunse et al. (1996) elevated the head of the patient’s bed to a maximum of 45 degrees¹⁶. On the other hand, in the study done by Farmanbar et al. (2012) the patients rested on their back for one hour while the angle of the bed was 30 to 45 degrees in the second hour with the sandbag in its place¹⁵. Patients in both the above studies were ambulated after four hours after angiography. Similar to present study, both studies reported that position change and early ambulation after angiography do not increase the risk of vascular complications but can bring patients some comfort. To avoid vascular complications, patients are usually instructed to rest in bed in a supine position with the affected leg in a straight position for 6-8 hours after coronary angiography. Due to this enforced supine bed rest, immobilization and restricted positioning, patients frequently experience back pain^2,25. The longer the duration of bed rest after angiography, the greater the patient is imposed to increased back pain, discomfort and fatigue^26,27. Lying on the back for a long time imposes pressure, and causes cellular ischemia and pain in the lumbar and the back³. It also causes pressure to be exerted continuously onto the same back muscles, causing muscle fatigue and weakness. This fatigue causes back pain due to back spasms²⁸. Therefore, patients intend to change their position so as to reduce the pain and discomfort^2,29. Inner-muscle pressure in lumbar muscles has a direct relation with the patients’ position and the imposed load on the muscles^29,30. Moreover, early ambulation allows the patient to sit comfortably and eat without difficulty. Leg numbness and urinary discomfort are also decreased.

In the light of the findings of the present study, it can be suggested that the position of the patients can be safely changed followed by an early ambulation of four hours after coronary angiography via the femoral route. This contributes to decreased back pain, increased comfort and reduced fatigue without increasing the incidence of vascular complications. Benefits of Non-pharmacological interventions and post-procedure intensive care are well evident in literature in improving the comfort of the patients and in reducing the distress of the caregivers^31-34. The differences in the experience and skills of the cardiologists who intervened for the coronary angiography via femoral route could not be assessed in present study, which could have affected the incidence of vascular complications.

CONCLUSION:

Findings of the study suggest that position change followed by early ambulation after coronary angiography via femoral approach helps in decreasing the severity of back pain, improving the comfort level and reducing the fatigue without increasing the risk of the vascular complications. In conclusion, it is safe to change the position of the patients at two hours and ambulate them four hours after coronary angiography via femoral route.

 

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Received on 26.03.2019         Modified on 20.05.2019

Accepted on 22.06.2019      ©A&V Publications All right reserved