Feeding Tube Attachment Device Versus Conventional Fixation and Its Impact on Accidental Exit of Enteral Feeding Tubes

NCT03262493 | Completed DMC

• 1 other identifier: 170217
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Enteral nutritional therapy, fed through the gastrointestinal tract via a catheter, tube, catheter, or stoma, delivers the nutrients distally to the oral cavity and may reduce intrahospital malnutrition. Enteral probes are inserted, at the bedside, through the nose or mouth into the stomach or duodenum. Among the main complications of the use enteral probes, we can mention: displacement of the probe and administration of diet in the respiratory tract or microaspirations. To prevent displacement, enteral probes are attached to the skin on the nose or forehead by the use of micropore-type adhesive. In the probe the adhesive tape is put in the form of "tie" and again fixed to the nose of the patient. The enteral probes displacement rates with this technique are around 62%; in addition, the adhesive tape can cause discomfort, nasal necrosis, skin lesions and skin sensitivity reactions to the patient. More recently the nasal bridle, an anchor of the enteral feeding tube located around the nasal septum or nasal septum, has been described as more effective in securing enteral probes position over traditional tape attachment, but is not available in our environment. In Brazil, the feeding tube attachment device (FTAD) is available. Until now, the performance of FTAD in relation to enteral probe safety and accidental exit rates has not been described in the literature. Material's FTAD is composed of a layer of hydrocolloid that is adhered to the skin on the back of the nose and a polyurethane clamp that secures the enteral probe. Thus, there was a need to evaluate the actual success in using the traditional mode of probe attachment. It should be noted that very little scientific evidence is available in the literature on such care, and this is due to the lack of well-designed studies on the subject.

Conditions

Adult; Enteral Nutrition; Tube Feeding

Keywords

intubation, gastrointestinal; nursing; clinical trial; enteral nutrition

Outcome Measures

Primary Outcomes (1)

• Number of accidental enteral probes exit per patient

  Will be accessed by the patient's chart

  Thirty fifth day

Secondary Outcomes (3)

• Reasons for the accidental enteral probes exit per patient and / or reintegration of enteral probes between the groups

  Thirty fifth day

• Administrated enteral nutrition volume per patient

  Thirty fifth day

• Time of fasting or delay in the use of enteral probes between groups

  Thirty fifth day

Study Arms (2)

Interventional Group

EXPERIMENTAL

It consists of the use of the feeding tube attachment device (FTAD) to fix the enteral probe.

Device: Interventional Group

Conventional Group

NO INTERVENTION

It consists of the fixation of the enteral probe with adhesive tape of the micropore type and plaster.

Interventions

Interventional Group DEVICE

Use of the feeding tube attachment device (FTAD).

Interventional Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults hospitalized in the clinic unit care: 6 sul e 7 norte
• Use of enteral nutrition in open system

You may not qualify if:

• Use of enteral nutrition by gastrostomy or jejunostomy

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Michelli Cristina Silva de Assis

Porto Alegre, Rio Grande do Sul, 90690270, Brazil

Location

Study Officials

• Michelli S de Assis, Doctorate

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: June 14, 2017
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: August 9, 2018

Record last verified: 2017-08

Locations

BR (1)