Research Study

Improving the Safety of Medical Tubing Maintenance via the Beata Clasp

This study indicates that nurses had favorable impressions of the Beata Clasp®, a product specifically developed to address the confusion and disorder generated by multiple tubes and lines. The majority of nurses judged the Beata Clasp® effective in reducing the "spaghetti syndrome", and believed it had a beneficial impact on patient safety and nursing efficiency. In particular, they cited its ability to maintain organized and separated lines, prevent lines from falling to the floor, and facilitate the tracing of lines back to their origin. Each of these functions positively impacts patient and staff safety.

Study Objective 

A new safety-oriented product called the Beata Clasp® was studied in the clinical setting to evaluate its effectiveness on reducing the incidence of tubing and line complications and improving operational efficiency of tubing care and management. 

Study Design & Setting 

The study was designed as a prospective controlled two-arm process improvement project and evaluated the effectiveness of a product designed to systematically hold intravenous (IV) lines in place. The product attaches to the IV pole or bedrail and acts as an accessory for tubing organization. Data were collected from Rush-Copley Medical Center, a community hospital of 157 beds. Study group assignments were organized at the nursing unit level (not the patient level) and participating nursing units were designated as either experimental or control group. Patients hospitalized on control units received usual care and procedure as relates to medical tubing management. Patients hospitalized on experimental units received usual care plus use of the Beata Clasp® as an accessory attached to the bed or IV pole.  

Endpoints 

The primary endpoints involved patient safety indices: the frequency of line incidents that require nursing intervention, result in the capacity to cause patient harm and/or result in actual patient harm, and descriptive characteristics of incidents and outcomes. The secondary endpoints targeted operational efficiency indices: total nursing or caregiver time directed toward tubing and line complications, and caregiver satisfaction with the Beata Clasp® product. 

Background 

Medical lines and tubing are abundant in clinical practice. It is not uncommon to see IV lines and other cables tangled when patients are mobile or in transport. Tubing is a potential source of harm when it becomes dislodged, impinged, entangled or wrapped around the patient's neck or limbs. Furthermore; the time required for nursing staff to untangle, reorganize or reinsert lines represents a significant operational inefficiency. 3 

Clinicians have repeatedly expressed frustration with the “spaghetti syndrome” of lines and tubing and negative effects on patient safety, although only a small base of research exists on the problem. 4,5 Of 114 line, tube and drain incidents reported in one prospective ICU study, >60% were considered preventable. Of patients experiencing an incident, 56% sustained physical injury, 23% had an increased hospital stay and one patient died. 1 An earlier prospective audit of intra-hospital transports found that 45% of complications experienced by critically ill patients were related to the transport environment, a category that included tubing entanglement and impingement. The study concluded the “mass tangle of lines” not only decreased hospital efficiency but increased the potential for medication error. 2 Another study described two cases of strangulation by intravenous tubing in infants, one of which was fatal. 6 The Emergency Care Research Institute (ECRI) database lists two additional cases of fatal strangulation by IV tubing occurring between 1984 and 1997. 7   The actual risk of strangulation by IV tubing or other lines, however, is not known as there are no reporting mandates. Data may only be available in facility incident reports or through voluntary reporting, and are likely to be underreported. It is possible that the overall number of tubes and lines used per patient may increase the risk of adverse events; however, data are not available to support this supposition. 

Prompted by the report on infant strangulation, 6 the Canadian government sponsored a national patient safety workshop to mitigate the risk of strangulation and other problems caused by medical tubing and monitor leads. The workshop resulted in a set of guidelines for improving tubing and line safety. 8 Recommendations included the adoption of technology to ensure properly separated, labeled and secured line connections as well as implementation of appropriate human factor engineering concepts to reduce the risk of tubing-related adverse events. 

In 2006, the Joint Commission issued a Sentinel Event Alert regarding tubing and catheter misconnection errors, citing them as an important an under-reported error in health care organizations. 9 At the time, nine cases involving tubing misconnections had been reported to the Joint Commission. These cases resulted in eight deaths and one instance of permanent loss of function. Often misconnection cases involve luer connectors - implicated because they enable functionally dissimilar tubes or catheters to be connected. But other identified causes included the routine use of tubes or catheters for unintended purposes (such as using IV extension tubing to extend enteric feeding tubes), and the positioning of functionally dissimilar tubes in close proximity to one another. The Joint Commission also cited movement of the patient from one setting or service to another, and staff fatigue associated with working consecutive shifts as contributing factors. ECRI recommended that the single most important work practice solution for clinicians is to trace all lines back to their origin before connecting or disconnecting any devices or infusions. 9 The “spaghetti syndrome” of entangled and wrapped lines, however, presents an obstruction to clean tracing. 

Product Development 

A functional solution to the “spaghetti syndrome” was sought. The Beata Clasp®, a soft foam clasp that attaches to bedrail, IV pole or wheelchair, was developed in response. The product works by securely fitting tubing and catheters into a bank of circular grooves. The intent is to reduce the risk of adverse tubing and line incidents by keeping lines separated and cleanly draped, and thus preventing line impingement, dislodging, entanglement and other complications. The product is also intended to prevent tubing from falling to the floor, thereby reducing contamination risks to patient and safety risks to caregivers. 

Study Results 

Line & Tubing Incidents . Study nurses on experimental and control units reported tubing and line incidents via a structured report form. An incident was defined as any partial or complete dislodgement, removal or other compromise of tubing or lines. Other compromises included entanglement, impingement or contamination among catheters, tubes or lines. 

Three line and tubing incidents took place during the length of the Beata Clasp® trial. However, one incident was excluded due to the lack of complete information. It is not known whether the patient was a Beata Clasp® or control patient. Statistically valid group comparisons are not presented due to the small number of reported incidents. 

There were zero reports of line or tubing incidents among patients on Beata Clasp®. There were two incident reports among control patients. Both incidents took place in the patient's bed during the 2 nd or 3 rd day of stay. One patient was less than nine years old while the second was over 55 years of age. 

In both cases, the patient became entangled in the lines and nursing intervention was required to resolve the problem. In one case, nursing intervention involved untangling lines which required between 6-10 minutes of time. In the second case, the intervention involved reinserting lines which required between 16-20 minutes of nursing time. In neither case was an adverse outcome reported as a result of the incident, nor was the patient caused any harm other than temporary discomfort or emotional distress. 

Nursing Efficiency and Satisfaction. Nurses who used the Beata Clasp® with their patients completed written surveys describing their impressions of the product. The survey included demographic information and Likert-type questions about product effectiveness in improving patient safety and nursing efficiency, and satisfaction with the Beata Clasp ® as a solution to line entanglement, dislodging, and impingement problems . Seven of eight respondents were staff nurses and the remaining individual was a charge nurse and preceptor. Experience levels ranged from less than one year to over 20 years in nursing. 

Each of the eight respondents reported a favorable impression of the Beata Clasp® (4=excellent impression and 4=good impression). All respondents indicated they were either very satisfied (n=5) or satisfied (n=3) with the product. Respondents also indicated their interest in having the Beata Clasp® available for future use with patients (5=very interested and 3=somewhat interested). 

In seven of eight cases, the responding nurse used the Beata Clasp® with less than 10 patients, and judged it either very effective (n=5) or effective (n=3). The majority (63%) felt that the overall quality and ease of use of the product was excellent. 

All nursing staff involved in the study reported that the concept of a line separator system is an excellent (n=4) or good (n=4) idea. They also reported that the effectiveness of the Beata Clasp® in keeping lines separated is either excellent (n=4) or good (n=4). 

Responses were somewhat more divided when asked about the degree of impact on patient safety (5=excellent, 3=good, 1=fair), and nursing efficiency and workload (4=excellent, 3=good, 2=fair). Some respondents were not sure that the patient benefited from the product (n=2) or that the nurse benefited (n=1).    

Each of the eight respondents indicated they would recommend the Beata Clasp® to other nurses. Some nurses would like to continue use of the Beata Clasp® because it effectively solved the problem of “spaghetti lines” (n=5), while others considered it only a minor improvement of the problem (n=3). 

Written comments centered on two themes. The first theme was ease of use. In general, the Beata Clasp® was considered easy to use. Safety is the second theme evident in the written comments. The ability of the Beata Clasp® to keep lines off the floor and organized was brought up by three individuals, and a fourth respondent observed improved safety for staff due to the decreased risk of tripping on extraneous tubing. Two respondents added they were able to easily trace lines from end to end when the Beata Clasp® was in place. 

Several respondents recommended improving the Beata Clasp® by increasing the number of slots to accommodate additional lines. Other recommended enhancements included adding a clasp to secure the line in place even further and decreasing the size of the slots (holes). 

Conclusions 

No conclusions can be drawn on the effectiveness of the Beata Clasp® in preventing tubing incidents such as entanglement or dislodging. Nor can any conclusions be drawn on its' effectiveness in reducing nursing time devoted to tubing management. The study design and small number of reported incidents precludes any conclusions based on reported incidents. 

This study indicates that nurses had favorable impressions of the Beata Clasp®, a product specifically developed to address the confusion and disorder generated by multiple tubes and lines. The majority of nurses judged the Beata Clasp® effective in reducing the “spaghetti syndrome”, and believed it had a beneficial impact on patient safety and nursing efficiency. In particular, they cited its ability to maintain organized and separated lines, prevent lines from falling to the floor, and facilitate the tracing of lines back to their origin. Each of these functions positively impacts patient and staff safety. 

Although most tubing and line problems are harmless or intercepted in time, complications with multiple lines can lead to adverse events that range in severity from mild to fatal. Effective intervention can limit or prevent the risk of adverse events and potential patient harm. Despite the difficulties in demonstrating significant benefit from safety initiatives in health care, these results suggest that the Beata Clasp® may be an effective strategy in improving the safety of medical tubing maintenance. Further objective study is necessary. 

References 

1. Needham DM, Sinopoli DJ, Thompson DA et al. (2005). A system factors analysis of “line, tube and drain” incidents in the intensive care unit. Crit Care Med ; 33(8): 1701-1707. 
2. Lovell MA, Mudaliar MY, Klineberg PL. (2001). Intra-hospital transport of critically ill patients: complications and difficulties. Anaesth Intensive Care; 4: 400-405. 
3. Pittsburgh Regional Healthcare Initiative (PRHI). (2002). Untangling a problem at West Penn. PRHI Executive Summary: prhi.org . Pittsburgh Regional Healthcare, Pittsburgh PA. 
4. Clark D. (1994). Untangling the “spaghetti syndrome” – inspiration for a business. Revolution ; 4(4): 55-56. 
5. Cook TM, Seavell CR. (1996). Patient transfer; what to do about the “spaghetti”. Anaesthesia; 51(1): 90-91. 
6. Garros D, King JW, Brady-Fryer B, et al. (2003). Strangulation with intravenous tubing: a previously undescribed adverse advent in children. Pediatrics ; 111; 732-734. 
7. Emergency Care Research Institute (ECRI). (2005). Adverse event database. 
8. Health Canada & Canadian Association of Paediatric Health Centres (CAPHC). (2003). Patient safety workshop June 14 th 2003: proceedings paper. Canadian Association of Paediatric Health Centres. Calgary, Alberta. 

Joint Commission. (2006). Tubing misconnections – a persistent and potentially deadly occurrence. Sentinel Event Alert; Issue 36; April 3, 2006.