Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure

NCT06510972 | Recruiting

• 1 other identifier: DR230315
• Study Type: interventional
• Target: 754
• Locations: 1 country
• Sites: 14

Brief Summary

Fasting in intensive care is mainly studied in mechanically ventilated patients or those in the weaning phase. Recent research challenge the common assumption of fasting and suggests that continuing enteral nutrition before extubation may be beneficial. Fasting is also practiced before procedures (e.g., tracheostomy, endoscopy) or surgeries, based on anesthetic guidelines. Yet, no data address fasting in non-intubated ICU patients with acute respiratory failure, despite frequent caloric deficits and inadequate nutritional intake. Aspiration risk often justifies fasting, but studies indicate that swallowing reflexes remain intact in patients receiving high-flow nasal oxygen or non-invasive ventilation. Moreover, although intubation carries a 2-5.9% aspiration risk, rapid sequence induction mitigates this, questioning the necessity of preventive fasting. Despite its prevalence, this practice lacks scientific validation and guideline support. Patient discomfort is also significant. Hunger and thirst are major sources of distress, and evidence from anesthesiology suggests that allowing fluid intake pre-anesthesia reduces discomfort. Extrapolating these findings to ICU patients could improve well-being. In conclusion, fasting in ICU patients may contribute to discomfort, dehydration, and malnutrition, while its protective benefits remain uncertain. We hypothesize that maintaining oral intake does not increase the risk of intubation or aspiration-related complications.

Conditions

Respiratory Insufficiency; Fasting; Dysphagia; Swallowing Disorder; Aspiration

Keywords

acute respiratory failure; fasting; oral intake; aspiration; intubation; high-flow nasal oxygen

Outcome Measures

Primary Outcomes (1)

• Percentage of patients intubated or dying without intubation within 96 hours of randomisation

  From randomisation to 96 hours

Secondary Outcomes (10)

• 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

Study Arms (2)

Oral intake continuation strategy

EXPERIMENTAL

The patient will be allowed to ingest liquids or solid foods orally, of any type, at an unrestricted frequency and quantity, according to their tolerance, with nurse assistance if necessary. Essential treatments will be administered orally when applicable. The patient will receive regular oral care. Both oral and intravenous intake will be quantified. The physician in charge must ensure that the patient receives a minimal caloric intake, either through intravenous glucose supplementation or parenteral nutrition, with the quantity left to the physician's discretion.

Procedure: Oral intake continuation strategy

Fasting strategy

ACTIVE COMPARATOR

The patient will not be allowed to ingest any liquids or solid foods. The patient will receive regular oral care. Essential oral medications, if no parenteral alternative is available, may be administered under nurse supervision (maximum daily water intake: 100 mL). The physician in charge must ensure that the patient receives a minimal caloric intake through intravenous glucose supplementation or parenteral nutrition, with the quantity left to the physician's discretion.

Procedure: Fasting strategy

Interventions

Fasting strategy PROCEDURE

The patient will not be able to ingest liquids or solid food.

Fasting strategy

Oral intake continuation strategy PROCEDURE

The patient will be allowed to ingest liquids or solid foods orally, of any type, at an unrestricted frequency and quantity, according to their tolerance.

Oral intake continuation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (14)

Intensive care, University Hospital, Blois

Blois, France

NOT YET RECRUITING

Intensive care, Hospital, Bourges

Bourges, France

RECRUITING

Intensive care, Hospital, Colombes

Colombes, France

RECRUITING

Intensive care, Hospital, Dreux

Dreux, France

RECRUITING

Intensive care, Hospital, La Roche sur Yon

La Roche-sur-Yon, France

RECRUITING

Intensive care, Hospital, Le MANS

Le Mans, France

RECRUITING

Intensive care, Hospital, Lille

Lille, France

RECRUITING

Intensive care, Hospital, Morlaix

Morlaix, France

RECRUITING

Intensive care, Hospital, Nantes

Nantes, France

RECRUITING

Intensive care, University Hospital, Orléans

Orléans, France

RECRUITING

Intensive care, Hospital, poitiers

Poitiers, France

RECRUITING

Intensive care, Hospital, Saint Brieuc

Saint-Brieuc, France

RECRUITING

Intensive care, Hospital, Saint-Nazaire

Saint-Nazaire, France

RECRUITING

Intensive care, University Hospital, Tours

Tours, France

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Fasting; Deglutition Disorders

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Feeding Behavior; Behavior; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Piotr SZYCHOWIAK, MD

  University Hospital, Orléans

  STUDY DIRECTOR

Central Study Contacts

Piotr SZYCHOWIAK, MD

CONTACT

2.38.22.95.58; piotr.szychowiak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 19, 2024
• Study Start: February 5, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2025-08

Locations

FR (14)