Man vs. Machine: A randomized controlled trial assessing the efficiency of vein-viewer over conventional methods of cannulation

Ruchika Rani, Priyanka Malhotra, Amandeep Kaur, Amolak Deep Kaur, Akashdeep Kaur, Aarti, Anjali Bhati, Anjali Thakur, Anshita, Anamika, Arpita

Introduction: Intravenous cannulation is the commonest nursing procedure in hospital settings. Various technologies are used to increase visibility of vein underneath skin. However, there is paucity of data on clinically signicant ndings related to cannulation methods. Objective: To assess the success rate and patient satisfaction with Vein Viewer vs. Conventional methods among patients undergoing intravenous cannulation admitted in selected wards of Hospital. Material and methods: A Randomized controlled trial and cross-over study design was conducted in AIIMS, Rishikesh, Uttarakhand. Total 50 participants were selected by using simple random sampling technique. Success rate, Numeric Pain Rating Scale and Patient Satisfaction Scale was used to collect data. Data was analyzed using descriptive and inferential statistics. Results: Mean duration of whole procedure (seconds) was signicantly more in vein viewer group (280.4±94.72) as compared to conventional group (164.96±86.95) with mean difference of 26.3 at p <0.001. There was statistically signicant difference in the score of patency of cannula with vein viewer vs. conventional group (2.04±0.62 vs. 2.32±0.53, p< 0.01). However, level of pain was not affected by any method of cannulation (p=0.12). But Mean patient’s satisfaction score in vein viewer versus conventional group was found signicant (3.28±1.01 vs. 3.70±0.886, p value 0.03). Conclusion: The present study concluded that the success rate of conventional methods was signicantly higher than Vein Viewer in terms of successful pricks in rst attempt, duration of whole procedure and patency of cannula. Participants were more satised with conventional method of cannulation.

Keywords: Conventional method; Patient satisfaction; Success rate; Vein viewer method

Address for correspondence:                           medications and uids for participantsMrs. Ruchika Rani

admitted to  the  hospital. 1    Patients

Assistant professor College of Nursing, AIIMS, Rishikesh.

Introduction:

Intravenous  cannulation  is the  most experience pain and anxiety with the intrusive process of cannulation. 2 Moreover, hazy visibility and difcult veins’ palpability leads to unsuccessful and multiple blind pricks, that become annoying procedure to both patients and frequently performed invasive procedure nurses.3     Similarly, Jacobson has listed for  the  systemic administration of twelve factors contributing to failed or complicated intravenous (IV) insertion based on veins, skin, and participants’ characteristics.4-6

Digitalized health care era and advanced technologies have upgraded pacing IV catheters’ accuracy with clear visibility of vein underneath the skin.6 Amongst leading technologies, Vein viewer, a portable means of visualizing veins, works on the principle of using near-infrared light on the hemoglobin in red blood cells, which further allow the image processing technology to project a picture on the top of the skin.7

Various studies had been conducted on the Vein Viewer against conventional methods “PET’ process which stands for practice question, evidence and translation.11-13 Various internal (equipment’s availability, standard, patient’s pain perception, satisfaction and nurses’ experiences and external (hospital policy, method of cannulation and patient care quality measures) factors inuence the decision making for use of evidence.

Material and methods: Trial Design

This study is a single centered, cross-over, randomized controlled two-arm trial, comparing intravenous cannulation with vein viewer and conventional methods in pediatric patients.8-9 Surprisingly, very among participants admitted in general few published studies are concerned with adult patients and their pain perception & s a t i s f actio n w i t h I V can n u l a t i o n w a r d s o f t e r t i a r y c a r e H o s p i t a l , Uttarakhand, North India. The trial was r e g i s t e r e d i n C l i n i c a l T r i a l . g o v methods.10, 11     However, some study results (CTRI/2019/09/021148) and was approved by Institutional Ethical Committee under in the literature are controversial in terms of methods of IV cannulation.10-12 Therefore to get substantial evidence regarding the efcacy of Vein Viewer over the conventional methods, the present study was designed to observe and compare different methods of IV cannulation and its impact on pain perception, patient reference number AIIMS/IEC/19/780, Date: 12/4/2019. The participants were informed about the condentiality of the information. An informed written consent was taken from participants.

Participants:

The sample size was estimated by using satisfaction,  and  success  rate  of IV formula (σ σ 2 (z ­   +z   )2/(m ­m )2    14with cannulation. We hypothesized no statistically signicant difference in the success rate, patient satisfaction about intravenous cannulation with Vein Viewer vs. conventional methods at 0.05 level of signicance.

The conceptual framework of this study was based on John Hopkins model Nursing EBP.11The model reects the

1+    2)           1   α/2       1­β                1         2

absolute error of 5% in cross-over trials to provide an 80% chance of identifying a signicant difference between the groups. Thus minimum estimated sample size after calculating attrition rate, was 100 arms. Consecutive sampling technique was used to recruit study participants age ≥18 years, need peripheral cannulation below the elbow, and understand and speak Hindi or English. Participants with central venous catheterization/ PICC line, having a skin disease, bleeding disorders, extravasation, and upper limb amputated and critically sick at the time of data collection were excluded from the study. We also excluded participants need emergent peripheral IV cannulation and taken analgesics one hour before the procedure.

Intervention: After obtaining written informed consent, participants were randomly allocated to two groups. For group 1, study participants were asked to clench their hands, then tourniquet was applied 10 cm proximal to the wrist and were asked to relax their hand. Vein viewer was positioned and stabilized with the stand to visualize the veins. The veins were assessed for visibility and palpability, cleaning the site, and attempted cannulation with an 18-20 Gauge needle, depending on vein’s diameter. According to institution protocol or any developing need to change site of cannulation, because of pain, thrombophlebitis, same participant was cannulated by another method of cannulation i.e. conventional method on another arm, by following similar way of preparation. Furthermore, in second group, with identical way of preparation and assessment, rst cannulation was performed by conventional method followed by next cannulation using vein viewer in another arm of same participant.

The same nurse attempted all cannulations in both the groups. One observer recorded the time duration of the whole procedure in seconds, starting from searching for an appropriate vein after application of a tourniquet to successfully conrmed cannulation (by administering normal saline without any signs of inltration). The researchers observed participants for 15 minutes for any redness, swelling, or any other complaints in both groups. Similarly, we recorded the number of attempts being failed to get successful cannulation. Participants were asked to rate the perceived level of pain and satisfaction with the procedure.

Outcome measures and Instruments:The primary outcome of the study was the success rate of cannulation. It was measured with a self-developed tool, using an observation technique. This structured tool consisted of number of pricks, the duration of the whole procedure (in seconds), and the patency of IV cannula (in days).

The secondary outcomes were the level of pain and participants’ satisfaction. The level of pain perceived was measured with the self-reporting method using standardized instruments of Numeric pain rating scale (NPRS). It is one dimensional measure of pain intensity and it is 11- point numeric scale ranges from ‘0’ representing no pain to ‘ 1 0 ‘ r e p r e s e n t i n g t h e w o r s t p a i n imaginable.15-16 Besides, Patient satisfaction was assessed by structured, Patient satisfaction tool, a ve-point rating scale to assess level of satisfaction ranging from very satised (5) to very dissatised (1).

B a s e l i n e d a t a i n c l u d e s p e r s o n a l demographic and clinical prole (age, gender, religion, marital status, education, socio-economic status, occupation, BMI, duration of hospital stay, size of cannula, history of addiction, and previous history of cannulation), and skin assessment prole (patient’s skin color, presence of hair, and turgidity). Vein status was evaluated by vein assessment scale (Lenhardt et al, 2002), ve point scale classied as veins neither visible nor palpable (1), veins visible but not palpable (2), veins barely visible and palpable (3), veins visible and palpable (4) and veins clearly visible and easily palpable (5).17-18The reliability of tools was calculated using the inter-rater method and found the reliability of vein a s s e s s m e n t s c a l e ( r = 0 . 7 ) p a t i e n t satisfaction scale (r=0.8), numeric pain rating scale (0.7) and on the other hand reliability of success rate tool was (r=0.9) that shows accepted level of reliability. The pilot study enabled the researcher to understand the feasibility of the study and test the instrument’s reliability.

Randomization: Eligible participants were randomly allocated to the vein viewer group or conventional IV cannulation group methods by a simple random sampling technique using ip a coin method with 1:1 treatment allocation method. The participants were allocated into two groups i.e. Group 1 and group 2. In Group 1, participants were cannulated by using Vein Viewer in rst cannulation followed by conventional method in next cannulation on the other hand (gure 1: CONSORT ) and it was vice-versa for Group 2, where participants cannulated by conventional method followed by Vein Viewer. It was an open trial study, hence patient and researchers were aware of the participation.

Statistical Analysis: Data was coded and entered to Microsoft excel and Statistical Package for the Social Sciences (SPSS 23.0). Descriptive and inferential statistics were used for analysis as per protocol. Participants who underwent cannulation with both methods i.e. vein viewer and conventional were taken for nal data analysis. Each participant was noted for two observations with two arms, one for vein viewer and another for conventional method. Thus total participants for the study was 50 with 100 observations

Results:

Socio- demographic profile of the participants: Participant characteristic proles were obtained from 50 participants (100 observations).The mean age of participants was 44.4±13.1 years ranging from 18-61 years old. Half of the participants (50%) were in the age group of 47-61 and males. More than half of the patients were cannulated by 22 gauze IV cannula. Nearly half (46%) of participants were having dehydrated skin turgor. Majority of participants had wheatish skin colour (62%) and BMI (68%) within normal r ange ( 18 – 24 ) . Maximum participants (90%) had previous experience with intravenous cannulation. Majority of the participants (62%) were not having any comorbid disorders.

Table 1: Socio-demographic and Personal profile of Participants

N=50

 

Variables f (%)
Age (in years)
18-31 08(16)
32-46 17(34)
47-61 25(50)
Mean age ± SD 44.4±13.1
Gender
Male 26(52)
Female 24(48)
Size of the cannula used (in gauze)
20G 24 (48)
22G 26 (52)
Skin complexion
Fair 05(10)
Wheatish 31(62)
Dark 14(28)
Skin turgor
Hydrated 27(54)
Dehydrated 23(46)

Table 1 displays the distribution of participants as per their socio-demographic and personal characteristics. Homogeneity of data could not be obtained because same participants were used for both groups i.e., Vein Viewer group and the conventional group

Figure 2: Pre-interventional vein assessment score of participants

Pre interventional vein assessment score17 showed that half of the participants (50%) were having barely visible and palpable veins (score 3) in vein viewer group and 38% of participants had visible and palpable veins (score 4) in conventional group. (gure 2).

Table 2: Success rate of IV cannulation among participants in Vein Viewer and conventional groups

N=50, n=100

Variables Vein Viewer group f (%)

nv=50

 Conventional group f (%)

nc=50

 p-value
Number of pricks

One

Two or more

Duration of whole procedure(seconds) (Mean ± SD)

Patency of cannula (in days)

(Mean ± SD)

 15(30)

35(70)

 31(62)

19(38)

 0.03**
 

280.4±94.72

  

164.9±86.95

  

<0.01**
2.04±0.53 2.32±0.62 0.01**

 

**statistically significant at p<0.05

The primary outcome of the study was the success rate of cannulation, assessed in terms of number of pricks, duration of whole procedure and patency of cannula. It was found that number of pricks (≥2) for successful cannulation were more in vein viewer group (70%) as compared to conventional group (38%) (p=0.03). Similarly, mean duration of whole procedure (in seconds) was signicantly higher in vein viewer group than conventional group (280.4± 94.72 vs. 164.9±86.95) at p=0.00. Furthermore, mean patency of cannula (in days) was signicantly less in vein viewer group as c o m p a r e d t o c o n v e n t i o n a l g r o u p (2.04±0.53 vs. 2.32±0.62) at p=0.01.

Hence, conventional method established as more effective for IV cannulation in terms of success rate (Table 2).

Table 3: Comparison of mean pain scores among participants in Vein Viewer and Conventional groups

n=100

Group Pain score p-value
Mean± SD Range
Vein Viewer group (n=50) 4.54±1.34 2-8  

0.12NS
Conventional    group (n=50) 4.08±1.60 2-9

NS-non-signicant at p>0.05

The secondary outcomes were the level of pain and participants’ satisfaction. There was no statistically signicant difference in pain scores in relation to cannulation by vein viewer vs. conventional method (4.54±1.34 vs. 4.08±1.60) at p=0.12. (Table 3).

Table 4: Comparison of satisfaction among participants in Vein Viewer and Conventional groups

n=100

 

Group

 Patient satisfaction score  

p- value
Mean± SD Range
Vein Viewer group (n=50) 3.28±1.01 1-5  

0.03*
Conventional               group (n=50) 3.70±0.88 3.00

 

*signicant (p<0.05)

The mean patient satisfaction scores were signicantly higher in conventional group (3.70±0.88) as compared to Vein Viewer group (3.28±1.01) at p=0.03. (Table 4). Hence, conventional methods are more effective over vein viewer in terms of participant’s satisfaction.

Discussion:

Vein viewer deviceis a standing device that illuminates near-infrared light above the imaging technology are smaller and may be associated with better staff utilization. All of these factors may inuence success or failure in cannulation.22 In the present study, the participants’ mean age was 44.4±13.1 years, with normal BMI (68%), admitted with medical conditions (58%) and have wheatish skin complexion with hydrated skin turgor. These ndings are in consistence with study results by skin from a distance of 30 cms to reduce the Chiao  et al. 7    reported  mean  age  of chance of cross-infection as well as to make nurse comfortable to cannulate with both hands.19 – 21 Newer generations of this participants was 42.4 years with normal BMI and fair skin complexion..

The success  rate  of IV cannulation measured in terms no. of pricks, duration of whole procedure (in seconds), and patency of cannula (in days). The present study results showed that rate of successful cannulation at rst attempt was higher in conventional group (62%) in comparison to Vein Viewer group (30%) at p=0.03.

The  present  study  established the s ignicant differences in patient satisfaction in relation to method of cannulation. Participants described more satisfaction with conventional method (3.70±0.8) as compared to Vein Viewer (3.28±1.01) with p=0.03. Similarly, Ramer Similar ndings were reported by Szmuk et et al 2 9    revealed signicantly higher al.23, Rothbart et al.24, Kaddoum RN et al9 who found rst-attempt cannulation success for Vein Viewer group vs. routine cannulation (47% vs.62%), (35% vs. 72%, p = 0.01), (75% vs.73%, p=0.85). In contrast to these ndings, de Graaff et al.25, 26 did not report any signicant difference with method of cannulation in success rate at rst attempt ranging (75.3% vs.73.1%, p = 0.93).

Besides, our results did not show any decline in t ime spent to perform venipuncture using Vein Viewer as compared to conventional methods, which was in conformity with ndings of the study satisfaction with vein viewer (p<0.05).

Conclusion: The present study provides signicant evidence that shows that the conventional methods already being used by the Indian nurses are better than the Vein Viewer technology in terms of number of pricks, duration, successful cannulation and patient satisfaction. Hence, it is more comfortable and efcient to use standard conventional methods to do cannulation over the vein viewer method. This may be due lack of skill among nurses in using vein viewer being a novice device. The nurses can be trained to enhance this skill so that they should also be well versed with conducted by Mcneely et al.27 (p=0.72), who showed no difference in mean duration of whole procedure between both the groups(McNeely et al., 2018). In the contrary, Rothbart et al.24, Aulagnier et al.28 described that less time was utilized for whole procedure in conventional group vs. vein viewer group (60 vs. 120 seconds p<0.01) (98 vs. 119 seconds).

Furthermore, in our study, there was no signicant difference in pain rating with methods of IV cannulation (conventional methods vs. Vein Viewer, 4.08 vs. 4.54, p=0.12). These ndings were comparable with study results conducted by Aulagnier et al28 who stated no signicant difference in pain scores (p=0.05). cannulation by using vein viewer.

Limitations: The limitations of this study were the time constraints and the study data was collected only from 50 participants. Further blinding could not be addressed for this study. Different cannula sizes may have some effect on the pain perception of the patient.

R e c o m m e n d a t i o n s : T h e s t u d y recommends that further studies should be undertaken to assess the efcacy of the Vein Viewer vs. Conventional method of intravenous cannulation among neonates in terms of successful cannulation and level of pain. A comparative study to nd the efcacy of Vein Viewer method over conventional intravenous cannulation methods in terms of skin complexion i.e., dark-skinned vs. light-skinned participants can also be undertaken. The incidence of hematoma, phlebitis, and thrombus formation can also be assessed by IV cannulation with Vein Viewer vs. Conventional method.

Conflict of interest: Nil

Funding: Self-funded

Ethical approval: The trial was registered i n         C l i n i c a l T r i a l . g o v (CTRI/2019/09/021148) and was approved by Institutional Ethical Committee under reference number AIIMS/IEC/19/780, Date: 12/4/2019. The participants were informed about the condentiality of the information. An informed written consent was taken from participants.

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