Optimization of Oral Diet in Critically Ill Patients (NAP-REA)

University Hospital Center (CHU)

Status: Terminated

Conditions: Nutrition; Critically Ill Patients; Food Intake

Treatments: Other: Personalized adapted oral diet and nutritional education

Study type: Interventional

Funder types: Other

Identifiers

NCT03354260

15715B-31 (Other Identifier)

9661 (Other Identifier)

Details and patient eligibility

About

The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.

Full description

This is a prospective randomized controlled single center clinical trial. This trial include patient over 18 year hospitalized in ICU and ventilated more than 5 days and/or with denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress. The randomization is awebsite randomization with stratification on age, presence of sepsis at inclusion, renal failure The day of the resumption of the oral feeding (J0), realization of a protocolized swallowing test then randomization and creation of a control and intervention group

Control group:

• Nutrition in resuscitation according to medical prescription: food recovery with a light meal consisting of soup and desserts and evolution to a normal meal according to the capabilities of patients
• Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
• Nutritional evaluation before the release of resuscitation.

Intervention group:

• NAP: "Customized Adapted Nutrition"
• Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
• Therapeutic education.
• Nutritional evaluation before the release of resuscitation.
• Creation at the exit of resuscitation of a nutritional linkage sheet with instructions food

The prospects for optimizing oral replenishment are multiple:

• reduce morbidity and mortality within 3 months after a stay in intensive care unit.
• improve autonomy and quality of life after a stay in intensive care.
• improve the privileged relationship with the patients' families.
• strengthen links within the resuscitation team and with downstream services.
• Educate patients on a nutritional level.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient 18 yo or above hospitalized in ICU and ventilated more than 5 days and/or with severe denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress

Exclusion criteria

• age under 18 yo, pregnancy,
• protected patients
• moribund patient (life expectancy of 48h or below),
• patient with disorders of swallowing
• tracheostomy
• patient with shock and/or respiratory distress

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

10 participants in 2 patient groups

intervention

Experimental group

Description:

Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU

Treatment:

Other: Personalized adapted oral diet and nutritional education

Control

No Intervention group