Actively Recruiting
Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation: a Non-inferiority Randomized Clinical Trial
Led by University Hospital, Tours · Updated on 2026-02-18
754
Participants Needed
14
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the effects of continuing oral intake versus fasting in adult patients with acute respiratory failure in intensive care units who are not intubated. This trial aims to evaluate whether allowing patients to eat and drink before potential intubation affects the risk of intubation or aspiration-related complications. The study addresses a gap in knowledge as current guidelines lack data on nutritional management for these patients despite common fasting practices and frequent nutritional deficits. Participants are randomly assigned to one of two groups: one group continues oral intake of liquids and solid foods without restrictions, supported by nursing assistance and regular oral care, while the other group follows a fasting protocol with no ingestion of food or liquids except minimal water for essential oral medications if needed. Both groups receive intravenous glucose or parenteral nutrition as necessary, and caloric intake is monitored. The study includes a 96-hour primary observation period after randomization. During the study, participants undergo assessments of respiratory status, nutritional intake, and discomfort levels such as thirst and hunger using verbal scales. Researchers monitor intubation rates, mortality, episodes of vomiting during intubation, salivary enzyme levels, and occurrences of pneumonia, renal failure, and hypoglycemia up to 28 days. The trial also tracks electrolyte levels and adverse events, with regular follow-up to evaluate safety and clinical outcomes over time.
CONDITIONS
Brief Title
Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older
- Affiliated to a social security scheme
- Able to provide oral consent or consent given by trusted support person or next of kin
- Hospitalized in an intensive care unit or continuous surveillance unit for less than 24 hours
- Acute hypoxaemic respiratory failure defined by respiratory rate over 25 breaths per minute or PaO2/FiO2 less than 200 mmHg or SpO2/FiO2 less than 235 under high concentration oxygen mask
You will not qualify if you...
- Criteria for immediate intubation such as respiratory rate over 40, respiratory failure signs, respiratory acidosis with pH less than 7.25, copious tracheal secretions, or hypoxia with SpO2 below 90% despite high oxygen
- Major hemodynamic failure needing increasing vasopressor support
- Neurological failure with Glasgow score less than 8
- Cardiac or respiratory arrest
- Severe chronic lung disease requiring long-term oxygen or ventilation
- Known swallowing problems or inability to swallow
- Admission for inhalation pneumonia or exclusive parenteral nutrition
- Presence of nasogastric, orogastric tube, jejunostomy, or feeding ileostomy
- Already on invasive mechanical ventilation
- Decision not to intubate or limitation of therapies
- Incapacitated adult under guardianship or curatorship
- Pregnant, breastfeeding, or parturient women
- Tracheostomized patient
- Previously included in this study for the first time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 hours from randomisation
Participants receive either continued oral intake of liquids and solid foods at any frequency and quantity according to their tolerance, or a fasting protocol with no oral intake. Both groups receive regular oral care and minimal caloric intake through intravenous or parenteral nutrition as needed.
Daily assessments during treatment period
Duration - Up to 28 days after randomisation
Participants are monitored for outcomes including intubation, mortality, and adverse events such as pneumonia or renal failure up to 28 days after randomisation.
Periodic visits or contacts up to Day 28
Trial Site Locations
Total: 14 locations
1
Intensive care, University Hospital, Blois
Blois, France
Not Yet Recruiting
2
Intensive care, Hospital, Bourges
Bourges, France
Actively Recruiting
3
Intensive care, Hospital, Colombes
Colombes, France
Actively Recruiting
4
Intensive care, Hospital, Dreux
Dreux, France
Actively Recruiting
5
Intensive care, Hospital, La Roche sur Yon
La Roche-sur-Yon, France
Actively Recruiting
6
Intensive care, Hospital, Le MANS
Le Mans, France
Actively Recruiting
7
Intensive care, Hospital, Lille
Lille, France
Actively Recruiting
8
Intensive care, Hospital, Morlaix
Morlaix, France
Actively Recruiting
9
Intensive care, Hospital, Nantes
Nantes, France
Actively Recruiting
10
Intensive care, University Hospital, Orléans
Orléans, France
Actively Recruiting
11
Intensive care, Hospital, poitiers
Poitiers, France
Actively Recruiting
12
Intensive care, Hospital, Saint Brieuc
Saint-Brieuc, France
Actively Recruiting
13
Intensive care, Hospital, Saint-Nazaire
Saint-Nazaire, France
Actively Recruiting
14
Intensive care, University Hospital, Tours
Tours, France
Actively Recruiting
Research Team
P
Piotr SZYCHOWIAK, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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