Enteral Nutrition
Conditions
Interventions
This is a pragmatic clinical trial of the crossover type, randomized by matched clusters, with three intervention groups (industrialized fixation device 3M, industrialized fixation device Hollister, a
180 adult patients (aged 18 years or older) will be included, with 60 patients per hospital allocated in three periods of 20 patients each
inclusion criteria comprise patients without previous nasal mucocutaneous injury, and exclusion criteria include known allergy to the materials of the devices, presence of systemic dermatological dise
randomization will occur by hospital using a randomly generated allocation sequence distributed confidentially to ensure allocation concealment
each hospital will use only one type of feeding tube fixation device for approximately three months, with a one-month washout period between intervention phases to prevent contamination
feeding tube fixation devices will be applied and removed exclusively by trained and calibrated field researchers according to a standardized Standard Operating Procedure
patients will be identified after admission to the intensive care unit, with informed consent obtained and eligibility screening including skin inspection
data collection includes daily skin inspection, sociodemographic and clinical variables of the patients, and information from nursing professionals involved in care,
SH1.030.005
Sponsors
Empresa Brasileira de Servicos Hospitalares - Ebserh
Santa Casa de Campo Grande
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients of both sexes (male and female); admitted to the adult intensive care units of the surveyed institutions; using a nasoenteric catheter; aged = 18 years; with no pre-existing nasal mucocutaneous injury.
Exclusion criteria
Exclusion criteria: Patients allergic to fixation device materials; with systemic dermatological disease; using the nasoenteral catheter for less than 24 hours; with cutaneous abnormality at the fixation site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Displacement of the nasoenteral catheter will be defined as any instance in which the catheter was removed or displaced before the prescribed time for discontinuation and therefore subsequently replaced during the participant’s stay in the intensive care unit; detachment of the nasoenteral catheter will be defined as the removal of any part of the adhesive tapes before the period recommended by the manufacturer for changing the fixation ends; removal may be partial, total, or global; medical adhesive-related skin injury (MARSI); pressure injury on mucous membrane associated with the nasoenteral catheter; duration of interruption of enteral diet infusion due to catheter displacement; volume of non-infused diet; and healthcare professionals’ satisfaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome in the intensive care unit will be defined as removal of the nasoenteral catheter, transfer to the ward, or death; hospital outcome will be defined as hospital discharge, transfer to another institution, or death | — |
Countries
Brazil
Contacts
Public ContactOleci Frota
Universidade Federal de Mato Grosso do Sul
Outcome results
None listed