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Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Intensive care, University Hospital, Blois
NOT_YET_RECRUITING
Blois
Intensive care, Hospital, Bourges
RECRUITING
Bourges
Intensive care, Hospital, Colombes
RECRUITING
Colombes
Intensive care, Hospital, Dreux
RECRUITING
Dreux
Intensive care, Hospital, La Roche sur Yon
RECRUITING
La Roche-sur-yon
Intensive care, Hospital, Le MANS
RECRUITING
Le Mans
Intensive care, Hospital, Lille
RECRUITING
Lille
Intensive care, Hospital, Morlaix
RECRUITING
Morlaix
Intensive care, Hospital, Nantes
RECRUITING
Nantes
Intensive care, University Hospital, Orléans
RECRUITING
Orléans
Intensive care, Hospital, poitiers
RECRUITING
Poitiers
Intensive care, Hospital, Saint Brieuc
RECRUITING
Saint-brieuc
Intensive care, Hospital, Saint-Nazaire
RECRUITING
Saint-nazaire
Intensive care, University Hospital, Tours
RECRUITING
Tours
Contact Information
Primary
Piotr SZYCHOWIAK, MD
piotr.szychowiak@gmail.com
2.38.22.95.58
Time Frame
Start Date: 2025-02-05
Estimated Completion Date: 2028-03
Participants
Target number of participants: 754
Treatments
Experimental: Oral intake continuation strategy
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.
Active_comparator: Fasting strategy
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Tours

This content was sourced from clinicaltrials.gov