Innovative Central Line Securement Device in the Pediatric Population

Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device

This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).

Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.

Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis, Short Gut Syndrome, Quality of Life, Pediatric Disorder

Patients with central lines ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Half of the participants will be randomized to the device arm while the other half of participants will be randomized to the non-device arm. They will be block randomized based on age upon enrollment. Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear. The study will follow participants prospectively for approximately one year (2020 - 2021).

Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study.

Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care.

The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.

This is a adhesive patch that is traditionally used to secure the external portion of a central line.

Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.

Inclusion Criteria: Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Exclusion Criteria: Those children who currently wear a central line securement device (vest) Children with central lines who are 19 years or older Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line complications. If the patient does develop breast during the time of the study then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.

Hwang FR, Stavropoulos SW, Shlansky-Goldberg RD, Mondschein JI, Patel AA, Solomon JA, Itkin M, Soulen MC, Chittams JL, Trerotola SO. Tunneled infusion catheter breakage: frequency and repair kit outcomes. J Vasc Interv Radiol. 2008 Feb;19(2 Pt 1):201-6. doi: 10.1016/j.jvir.2007.08.030.

Lundgren IS, Zhou C, Malone FR, McAfee NG, Gantt S, Zerr DM. Central venous catheter repair is associated with an increased risk of bacteremia and central line-associated bloodstream infection in pediatric patients. Pediatr Infect Dis J. 2012 Apr;31(4):337-40. doi: 10.1097/INF.0b013e31823eeec5.

Cesaro S, Corro R, Pelosin A, Gamba P, Zadra N, Fusaro F, Pillon M, Cusinato R, Zampieri C, Magagna L, Cavaliere M, Tridello G, Zanon G, Zanesco L. A prospective survey on incidence and outcome of Broviac/Hickman catheter-related complications in pediatric patients affected by hematological and oncological diseases. Ann Hematol. 2004 Mar;83(3):183-8. doi: 10.1007/s00277-003-0796-9. Epub 2003 Nov 13.

Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.

Peng C, Monagle P, Newall F. Clinical outcomes of management of CVAD occlusions. Arch Dis Child. 2011 Sep;96(9):885-7. doi: 10.1136/adc.2010.194969. Epub 2011 Mar 11.

Rey C, Alvarez F, De La Rua V, Medina A, Concha A, Diaz JJ, Menendez S, Los Arcos M, Mayordomo-Colunga J. Mechanical complications during central venous cannulations in pediatric patients. Intensive Care Med. 2009 Aug;35(8):1438-43. doi: 10.1007/s00134-009-1534-0. Epub 2009 Jun 16.

Winkler MF, DiMaria-Ghalili RA, Guenter P, Resnick HE, Robinson L, Lyman B, Ireton-Jones C, Banchik LH, Steiger E. Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1140-1149. doi: 10.1177/0148607115586575. Epub 2015 May 13.

Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. doi: 10.1186/1477-7525-1-60.

Gimeno-Santos E, Raste Y, Demeyer H, Louvaris Z, de Jong C, Rabinovich RA, Hopkinson NS, Polkey MI, Vogiatzis I, Tabberer M, Dobbels F, Ivanoff N, de Boer WI, van der Molen T, Kulich K, Serra I, Basagana X, Troosters T, Puhan MA, Karlsson N, Garcia-Aymerich J; PROactive consortium. The PROactive instruments to measure physical activity in patients with chronic obstructive pulmonary disease. Eur Respir J. 2015 Oct;46(4):988-1000. doi: 10.1183/09031936.00183014. Epub 2015 May 28.