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Compares treatment options for Respiratory Insufficiency
Official title Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
ClinicalTrials.gov ID: NCT06510972
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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...
- 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...
See the full eligibility 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)
- 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 ) \ 80% for more than 5 minutes without technical...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Blois, France
- Bourges, France
- Colombes, France
- Dreux, France
- La Roche-sur-Yon, France
- Le Mans, France
- Lille, France
- Morlaix, France
- Nantes, France
- Orléans, France
- Poitiers, France
- Saint-Brieuc, France
- Saint-Nazaire, France
- Tours, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Blois, France; Bourges, France; Colombes, France; Dreux, France; La Roche-sur-Yon, France; Le Mans, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.