Clinical trial NCT06510972: Non-inferiority of a Strategy of Continuing Oral Intake Compared With Fasting
Official title: Non-inferiority of a Strategy of Continuing Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure at Risk of Tracheal Intubation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patient in Acute Respiratory Failure
Continuation of Oral Intake
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years old
* Participant affiliated to a social security scheme
* Express oral consent of the participant, or failing that of the trusted support person, or failing that of the next of kin
* Patient hospitalised in an intensive care unit or in a continuous surveillance unit or in an intensive care unit for less than 24 hours.
* Criteria for acute hypoxaemic respiratory failure defined as.

  * Respiratory rate \> 25 cpm or indifferent if SARS-CoV-2 (Severe acute respiratory syndrome coronavirus 2) infection occurred ≥ 1 time since admission.
  * PaO2/FiO2 \< 200 mmHg or equivalent SpO2 (oxygen saturation)/FiO2 (fraction of inspired oxygen) i.e. \< 235 (measured under at least 10 L/min high concentration mask)

Exclusion Criteria:

* Patient with criteria for immediate intubation:

  * Persistent or worsening respiratory failure (respiratory rate \> 40/min, respiratory failure on physical examination, respiratory acidosis with pH (hydrogen potential ) \< 7.25, copious tracheal secretions, hypoxia with SpO2 \< 90% despite FiO2 \> 80% for more than 5 minutes without technical dysfunction).
  * Major haemodynamic failure (need for increasing vasopressor support with instability and hypoperfusion).
  * Neurological failure (Glasgow score \< 8).
  * Cardiac or respiratory arrest
* Chronic lung disease: chronic obstructive pulmonary disease (GOLD grade 3 or 4: Global Initiative for Chronic Obstructive Lung Disease) or other chronic lung disease requiring long-term oxygen or ventilation (this does not include a patient undergoing continuous positive nocturnal pressure for sleep apnoea syndrome).
* Contraindications to oral nutrition: known previous swallowing problems or inability to swallow, digestive sutures, admission for inhalation pneumonia, exclusive parenteral nutrition, etc.
* Patients with a nasogastric or orogastric tube, a jejunostomy or a feeding ileostomy
* Patient already on invasive mechanical ventilation on admission
* Limitation of therapies including a decision not to intubate
* Incapacitated adult (guardianship or curators)
* Pregnant, parturient or breast-feeding women
* Tracheostomised patient
* Patient already included for the first time in this study

Primary outcomes:
measure: Percentage of patients intubated or dying without intubation within 96 hours of randomisation
timeFrame: From randomisation to 96 hours
Secondary outcomes:
measure: Simple verbal scale between 1 and 4 of sensation of thirst and hunger at D1 after randomisation
timeFrame: At Day 1 after randomisation
measure: Mortality at D28
timeFrame: At Day 28
measure: Time from randomisation to intubation to Day 28
timeFrame: From randomisation to day 28
measure: Occurrence of vomiting during intubation
timeFrame: Between the start and end of the intubation procedure
measure: Immediate post-intubation salivary amylase and pepsin rates
timeFrame: Immediate post-intubation
measure: Natraemia rates within 4 days of randomisation
timeFrame: From randomisation to day 4
measure: Occurrence of acute renal failure within 4 days of randomisation
timeFrame: From randomisation to day 4
measure: Occurrence of hypoglycaemia within 4 days of randomisation
timeFrame: From randomisation to day 4
measure: Occurrence of at least one nosocomial pneumonia within 28 days of randomisation
timeFrame: From randomisation to day 28
measure: Occurrence of at least one pneumonia acquired under early mechanical ventilation
timeFrame: From randomisation to day 28
Other outcomes:
Locations:
city: Blois
country: France
facility: Intensive care, University Hospital, Blois
city: Bourges
country: France
facility: Intensive care, Hospital, Bourges
city: Colombes
country: France
facility: Intensive care, Hospital, Colombes
city: Dreux
country: France
facility: Intensive care, Hospital, Dreux
city: La Roche-sur-Yon
country: France
facility: Intensive care, Hospital, La Roche sur Yon
city: Le Mans
country: France
facility: Intensive care, Hospital, Le MANS
city: Lille
country: France
facility: Intensive care, Hospital, Lille
city: Morlaix
country: France
facility: Intensive care, Hospital, Morlaix
city: Nantes
country: France
facility: Intensive care, Hospital, Nantes
city: Orléans
country: France
facility: Intensive care, University Hospital, Orléans
city: Tours
country: France
facility: Intensive care, University Hospital, Tours
Study officials:
affiliation: University Hospital, Orléans
name: Piotr SZYCHOWIAK, MD
role: STUDY_DIRECTOR
References: