Innovative Central Line Securement Device in the Pediatric Population

NCT04522778 | Terminated Results DMC FDA Device

• 1 other identifier: STUDY19010059
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Primary Outcome - Line Breaks

  Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.

  For a maximum of 1 year from enrollment

• Primary Outcome - Line Replacement

  Number of line replacements in which a line was removed from the patient and a new line was placed.

  For a maximum of 1 year from enrollment

• Primary Outcome - Line Infections

  Number of line infections defined as a positive blood culture drawn from a central line.

  For a maximum of 1 year from enrollment

Secondary Outcomes (27)

• How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?

  Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

• How Has the Vest or Dressing Affected Your Child's Ability to be Active?

  Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses for an individual was 5 over a 12 month period.

• How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?

  Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

• How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?

  Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

• Have You Been Worried About the Safety of Your Child's Central Line?

  Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.

Study Arms (2)

Device

EXPERIMENTAL

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.

Device: Wearable Central Line Securement Device (Vest); Other: Traditional Securement Dressing

Traditional Securement Dressing

ACTIVE COMPARATOR

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

Other: Traditional Securement Dressing

Interventions

Wearable Central Line Securement Device (Vest) DEVICE

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.

Device

Traditional Securement Dressing OTHER

All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.

Device; Traditional Securement Dressing

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ryan St. Pierre-Hetz: lead

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (9)

• 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.

  PMID: 18341949 BACKGROUND

• 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.

  PMID: 22146741 BACKGROUND

• 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.

  PMID: 15064868 BACKGROUND

• 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.

  PMID: 26459655 BACKGROUND

• 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.

  PMID: 21398316 BACKGROUND

• 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.

  PMID: 19529913 BACKGROUND

• 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.

  PMID: 25972431 BACKGROUND

• 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.

  PMID: 14613562 BACKGROUND

• 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.

  PMID: 26022965 BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations include small sample size, loss of follow up and poor compliance.

Results Point of Contact

• Title: Ryan St. Pierre-Hetz
• Organization: UPMC

stpierrehetzre@upmc.edu

3154369898

Study Officials

• Angelica Mazzarini, MD

  UPMC Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Attending

Model Details: 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).

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 21, 2020
• Study Start: November 5, 2020
• Primary Completion: September 15, 2022
• Study Completion: May 1, 2023
• Last Updated: July 5, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)