NCT03262493

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

Completed NA Last updated 9 August 2018

What this trial tests

NA trial testing Interventional Group in Adult in 104 participants. Completed in 31 March 2018.

Timeline

14 June 2017

Primary endpoint
31 December 2017

31 March 2018

Quick facts

Lead sponsor	Hospital de Clinicas de Porto Alegre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	104
Start date	14 June 2017
Primary completion	31 December 2017
Estimated completion	31 March 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Interventional Group

Conditions studied

• Adult — all drugs for Adult →
• Enteral Nutrition — all drugs for Enteral Nutrition →
• Tube Feeding — all drugs for Tube Feeding →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

Adults 18 to 99, any sex, with Adult or Enteral Nutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.