Non-inferiority of a Strategy of Continuing Oral Intake Compared With Fasting
NCT Number: NCT06510972
Acronym: JEUN-TUBE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Patient in Acute Respiratory Failure|Continuation of Oral Intake
Interventions: PROCEDURE: Strategy for continuing oral intake|PROCEDURE: Fasting strategy
Sponsor: University Hospital, Tours
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 754
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2027-10
Locations: Intensive care, University Hospital, Blois, Blois, France|Intensive care, Hospital, Bourges, Bourges, France|Intensive care, Hospital, Colombes, Colombes, France|Intensive care, Hospital, Dreux, Dreux, France|Intensive care, Hospital, La Roche sur Yon, La Roche-sur-Yon, France|Intensive care, Hospital, Le MANS, Le Mans, France|Intensive care, Hospital, Lille, Lille, France|Intensive care, Hospital, Morlaix, Morlaix, France|Intensive care, Hospital, Nantes, Nantes, France|Intensive care, University Hospital, Orléans, Orléans, France|Intensive care, University Hospital, Tours, Tours, France

Summary:
Fasting in the intensive care unit is a crucial issue and has been studied in particular in patients on mechanical ventilation or at the time of weaning. To date, there are no data on fasting in patients with acute respiratory failure hospitalised in the intensive care unit but not intubated.

The nutritional attitude to adopt in these patients is not mentioned in the recommendations on nutrition for intensive care patients, even though it has been proven in the literature that this specific category of patients does not achieve the theoretical calorie targets, particularly as a large proportion of these patients are not fed, whether orally (or per os), enteral via a naso- or oro-gastric tube or parenterally. There is therefore a real rationale for trying to maintain a nutritional intake in patients with acute respiratory failure.

One of the fears of the team caring for a patient in acute respiratory failure is the potential occurrence of false routes.

In addition to false routes, orotracheal intubation of patients requiring mechanical ventilation in intensive care presents a risk of inhalation of gastric contents followed by the potential development of pneumonia.

In the clinical setting, inhalation may not be symptomatic, but may progress to severe pneumonia and acute respiratory distress syndrome, pulmonary fibrosis and therefore be life-threatening.

By analogy, in intensive care, patients at risk of intubation are put on a fast as a preventive measure to limit the risk of a false route and the risk of potential inhalation in the event of intubation. This practice, which is very common on admission to intensive care and continuous care units, has not been studied in the literature and is not the subject of recommendations.

Finally, patients hospitalised in intensive care are subject to numerous discomforts.

The hypothesis put forward is that the continuation of intravenous fluids in intensive care units for patients at risk of intubation does not increase the need for intubation and does not increase adverse effects such as false routes or inhalation of gastric contents in patients who ultimately require intubation.

Primary Outcome Measures: Percentage of patients intubated or dying without intubation within 96 hours of randomisation, From randomisation to 96 hours
Secondary Outcome Measures: Simple verbal scale between 1 and 4 of sensation of thirst and hunger at D1 after randomisation, At Day 1 after randomisation|Mortality at D28, At Day 28|Time from randomisation to intubation to Day 28, From randomisation to day 28|Occurrence of vomiting during intubation, Between the start and end of the intubation procedure|Immediate post-intubation salivary amylase and pepsin rates, Immediate post-intubation|Natraemia rates within 4 days of randomisation, From randomisation to day 4|Occurrence of acute renal failure within 4 days of randomisation, From randomisation to day 4|Occurrence of hypoglycaemia within 4 days of randomisation, From randomisation to day 4|Occurrence of at least one nosocomial pneumonia within 28 days of randomisation, From randomisation to day 28|Occurrence of at least one pneumonia acquired under early mechanical ventilation, From randomisation to day 28