Innovative Central Line Securement Device in the Pediatric Population

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04522778
• Other study ID #: STUDY19010059
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: July 2023

Study information

• Verified date: September 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Line Complication
• Central Line Infection
• Central Line Sepsis
• Central Line-Associated Infection
• Communicable Diseases
• Infections
• Pediatric Disorder
• Quality of Life
• Short Bowel Syndrome
• Short Gut Syndrome

Intervention

Device:
• Wearable Central Line Securement Device (Vest)
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.

Other:
• Traditional Securement Dressing
This is a adhesive patch that is traditionally used to secure the external portion of a central line.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Ryan St. Pierre-Hetz

Country where clinical trial is conducted

United States, 

References & Publications (9)

Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003 Oct 23;1:60. Review. — View Citation

Cesaro S, Corrò 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. Epub 2003 Nov 13. — View Citation

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, Basagaña 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rey C, Alvarez F, De La Rua V, Medina A, Concha A, Díaz JJ, Menéndez 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. — View Citation

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. Review. — View Citation

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. Epub 2015 May 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome - Line Breaks	Number of line breaks	For a maximum of 1 year from enrollment
Primary	Primary Outcome - Line Dislodgment	Number of line dislodgments	For a maximum of 1 year from enrollment
Primary	Primary Outcome - Line Infections	Number of and line infections	For a maximum of 1 year from enrollment
Secondary	Change from baseline in parental stress at 3 months	Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs.3months
Secondary	Change from baseline in parental stress at 6 months	Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 6 months
Secondary	Change from baseline in parental stress at 9 months	Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 9 months
Secondary	Change from baseline in parental stress at 12 months	Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 12 months
Secondary	Change from baseline in child activity level at 3 months	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.	Baseline vs. 3 months
Secondary	Change from baseline in child activity level at 6 months	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.	Baseline vs. 6 months
Secondary	Change from baseline in child activity level at 9 months	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.	Baseline vs.9 months
Secondary	Change from baseline in child activity level at 12 months	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.	Baseline vs.12 months
Secondary	Change from baseline in sleep at 3 months	Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 3 months
Secondary	Change from baseline in sleep at 6 months	Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 6 months
Secondary	Change from baseline in sleep at 9 months	Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 9 months
Secondary	Change from baseline in sleep at 12 months	Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 12 months
Secondary	Change from baseline in school at 3 months	Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 3 months
Secondary	Change from baseline in school at 6 months	Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 6 months
Secondary	Change from baseline in school at 9 months	Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 9 months
Secondary	Change from baseline in school at 12 months	Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 12 months
Secondary	Change from baseline in extracurricular activities at 3 months	Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 3 months
Secondary	Change from baseline in extracurricular activities at 6 months	Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs.6 months
Secondary	Change from baseline in extracurricular activities at 9 months	Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 9 months
Secondary	Change from baseline in extracurricular activities at 12 months	Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 12 months
Secondary	Change from baseline in family travel at 3 months	Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 3 months
Secondary	Change from baseline in family travel at 6 months	Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 6 months
Secondary	Change from baseline in family travel at 9 months	Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 9 months
Secondary	Change from baseline in family travel at 12 months	Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire.	Baseline vs. 12 months