Critical Care, Enteral Nutrition, Feeding Methods, Gastric Feeding Tube
Conditions
Keywords
Gastric Emptying, Diarrea, Vomiting, Respiratory Aspiration of Gastric Content, Caloric Intake, Enteral nutrition, Critical care
Brief summary
The goal of this clinical trial is to Determine efficacy of intermittent enteral nutrition vs continuous enteral nutrition in adults patients with a nasogastric tube in a intensive care unit. The main question\[s\] it aims to answer are: * Reduction of gastrointestinal and respiratory complications * Evaluate the achievement of the caloric objective Informed consent will be requested from participants who meet the inclusion criteria. The participants will be randomized into two groups: control group (continuous enteral nutrition) or experimental group (intermittent enteral nutrition) Researchers will compare intermittent enteral nutrition vs continuous to see if there is a reduction in gastrointestinal and respiratory complications.
Interventions
OTHERINTERMITTENT ENTERAL NUTRITITION (IEN)
Administration of Enteral Nutriton (EN) by nasogastric tube in 4 bolus (24h): Duration of the infusion 1hour each shot, using an infusion pump.
OTHERCONTINUOS ENTERAL NUTRITITION (CEN)
Administration of Enteral Nutriton (EN) by nasogastric tube during 24 hours, using an infusion pump.
Sponsors
University of Castilla-La Mancha
Complejo Hospitalario Universitario de Albacete
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
By the nature of the intervention(intermittent or continuous administration of enteral nutrition) is impossible to mask it to participats, care provider or investigators.
Intervention model description
The patients wil be allocated to expriemental group or control group using a simple randomization sequence. There is an allocation concealment using sealed opaque envelopes Duration: From February 2022 to complete sample number.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted to ICU of University General Hospital of Albacete * Need for enteral nutrition by nasogastric tube in the first 48 hours * Signed informed consent
Exclusion criteria
* Insulin dependent diabetic patients * Abdominal surgery * Dire prognosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Complications | during ICU stay (maximum 15 days) | Respiratory aspiration of gastric content |
| Gastrointestinal Complications | during ICU stay (maximum 15 days) | Digestive intolerance: Diarrhea, vomiting, increased gastric residual volume(GRV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of the caloric objective | during ICU stay (up to 15 days) | Time in hours to reach caloric goal |
| Nutritional status: MNA | up to two days after admission to the ICU | Measure with:Mini Nutritional Assessment,(MNA) 12-14 points: Normal nutritional status 8-11 points: risk of malnutrition 0-7 points: Malnutrition |
| Changes in blood glucose | during ICU stay (maximum 15 days) | Episodes of hypoglycemia or hyperglycemia |
| ICU Stay | From date of randomization until 100 months | Days of stay in ICU |
| Mortality | until the date of death from any cause until 100 months | Percentage of deaths in ICU |
| Change of type of EN administration | during ICU stay (maximum 15 days) | Change of EN administration modality |
| Nutritional status:Glim Criteria | up to two days after admission to the ICU | Measure with: Glim criteria: Phenotypic criteria:Non-volitional weight loss (%) Low BMI (kg/m2)Reduced muscle mass(calf circumference (cm)) Etiologic criteria: Reduced food intake or assimilation. Inflammation \*Requires at least one phenotypic criterion and one etiologic criterion for the diagnosis of malnutrition |
| Nutritional status: Biochemical values | up to two days after admission to the ICU | Measure with:biochemical values: albumin, prealbumin, total protein |
Countries
Spain
Contacts
Primary ContactM.Dolores Saiz-Vinuesa, NURSE
Backup ContactM.Pilar Córcoles-Jimenez, NURSE
Outcome results
None listed