Respiratory InsufficiencyJEUN-TUBENCT06510972
Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure
A study testing Oral intake continuation strategy and Fasting strategy in people with Respiratory Insufficiency and Fasting, run by University Hospital, Tours at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Fasting, Dysphagia
- What is being tested?
- Oral intake continuation strategy and Fasting strategy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 754 participants
- Where
- 14 sitesFrance
- Study dates
- 5 Feb 2025to Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites, 14 recruiting
- Not yet recruiting
Intensive care, University Hospital, Blois
Blois
Julien GROUILLE, MD
Julien GROUILLE, MD
- Recruiting
Intensive care, Hospital, Bourges
Bourges
Anna BOURREAU, MD
Anna BOURREAU
- Recruiting
Intensive care, Hospital, Colombes
Colombes
Damien ROUX, MCU-PH
Damien ROUX
- Recruiting
Intensive care, Hospital, Dreux
Dreux
Thomas JANSON, MD
Thomas JANSON
- Recruiting
Intensive care, Hospital, La Roche sur Yon
La Roche-sur-Yon
Laureen GUILLEMIN, MD
Laureen GUILLEMIN, MD
- Recruiting
Intensive care, Hospital, Le MANS
Le Mans
Mickael LANDAIS, MD
Mickael LANDAIS
- Recruiting
Intensive care, Hospital, Lille
Lille
Saadalla NSEIR, MD
Saadalla NSEIR
- Recruiting
Intensive care, Hospital, Morlaix
Morlaix
Pierre-Yves EGRETEAU, MD
Pierre-Yves EGRETEAU
- Recruiting
Intensive care, Hospital, Nantes
Nantes
Jean REIGNIER, MCU-PH
Jean REIGNIER
- Recruiting
Intensive care, University Hospital, Orléans
Orléans
Piotr SZYCHOWIAK, MD
Piotr SZYCHOWIAK
- Recruiting
Intensive care, Hospital, poitiers
Poitiers
Sylvain LE PAPE, MD
Sylvain LE PAPE
- Recruiting
Intensive care, Hospital, Saint Brieuc
Saint-Brieuc
Nicolas MASSART, MD
Nicolas MASSART
- Recruiting
Intensive care, Hospital, Saint-Nazaire
Saint-Nazaire
Patricia COUROUBLE, MD
Patricia COUROUBLE
- Recruiting
Intensive care, University Hospital, Tours
Tours
Stephan EHRMANN
About this study
Official title: Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
Fasting in intensive care is a crucial issue that has primarily been studied in mechanically ventilated patients or during the mechanical ventilation weaning process. This practice has recently been challenged with a study which demonstrated the benefits of continuing enteral nutrition before extubation compared to maintaining an empty stomach. Fasting has also been studied in the context of technical procedures (such as tracheostomy or endoscopy) and before surgery, based on an analogy with pre-anesthetic fasting recommendations.
To our knowledge, no data are available regarding fasting in critically ill patients with acute respiratory failure who are hospitalized in the ICU but not intubated. Nutritional management in this specific patient population is not addressed in current ICU nutrition guidelines, despite evidence in the literature showing that these patients frequently fail to meet theoretical caloric targets. A large proportion of them receive no nutritional intake, whether orally, enterally via a nasogastric or orogastric tube, or parenterally. This highlights a strong rationale for maintaining nutritional support in patients with acute respiratory failure.
One of the major concerns among healthcare teams managing these patients is the potential risk of aspiration. This often leads to delays in resuming oral intake, with patients remaining fasting, possibly as an overly cautious approach. However, several experimental studies, including animal models and studies in patients with acute respiratory failure receiving respiratory support (such as high-flow nasal oxygen therapy or non-invasive ventilation), suggest that swallowing reflexes remain intact in these situations.
Beyond aspiration concerns, tracheal intubation in ICU patients requiring mechanical ventilation carries a risk of gastric content aspiration, estimated between 2% and 5.9% in different studies, potentially leading to pneumonia. Clinically, aspiration may be asymptomatic but can also result in severe pneumonia, acute respiratory distress syndrome, pulmonary fibrosis, and, ultimately, life-threatening complications.
During anesthesia for scheduled surgery, controlled operating room conditions allow for preoperative fasting (six hours without solid food and two hours without clear liquids) before anesthetic induction. By analogy, in intensive care, patients at risk of intubation are often kept fasting as a preventive measure to reduce the risk of aspiration and potential gastric content inhalation in the event of intubation. However, this common practice in ICUs remains unstudied in the literature and is not included in clinical guidelines. Moreover, the systematic use of rapid sequence induction techniques during emergency intubation minimizes the risk of aspiration, potentially reducing the need for preemptive fasting.
Finally, ICU patients experience multiple discomforts. Several studies, including a French study validating the IPREA score, have identified hunger and, more notably, thirst as major sources of discomfort in the ICU. In anesthesiology, preoperative comfort has been extensively studied, and research has shown that allowing patients to drink before general anesthesia significantly reduces thirst and hunger sensations. It is reasonable to extrapolate these findings to ICU patients with acute respiratory failure, suggesting that permitting the intake of liquids and solid foods could improve their overall comfort.
Thus, fasting in the ICU may be potentially harmful - hunger and thirst are frequent sources of discomfort, and dehydration and malnutrition are often inadequately compensated by parenteral routes - while its benefits remain uncertain.
We hypothesize that continuing oral intake in ICU patients at risk of intubation does not increase the need for intubation and does not lead to higher rates of adverse events, such as aspiration or gastric content inhalation, in patients who ultimately require intubation.
- Conditions
- Respiratory Insufficiency, Fasting, Dysphagia, Swallowing Disorder, Aspiration
- Being tested
- Oral intake continuation strategy, Fasting strategy
- Keywords
- acute respiratory failure, fasting, oral intake, aspiration, intubation, high-flow nasal oxygen
- Medical subject headings
- Respiratory Insufficiency, Fasting, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral intake continuation strategyProcedure or surgery
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.
Fasting strategyProcedure or surgery
The patient will not be able to ingest liquids or solid food.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Fasting strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients intubated or dying without intubation within 96 hours of randomisation
Measured: 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
Measured: At Day 1 after randomisation
Mortality at D28
Measured: At Day 28
Time from randomisation to intubation to Day 28
Measured: From randomisation to day 28
Occurrence of vomiting during intubation
Measured: Between the start and end of the intubation procedure
Immediate post-intubation salivary amylase and pepsin rates
Measured: Immediate post-intubation
Natraemia rates within 4 days of randomisation
Measured: From randomisation to day 4
Occurrence of acute renal failure within 4 days of randomisation
Measured: From randomisation to day 4
Occurrence of hypoglycaemia within 4 days of randomisation
Measured: From randomisation to day 4
Occurrence of at least one nosocomial pneumonia within 28 days of randomisation
Measured: From randomisation to day 28
Occurrence of at least one pneumonia acquired under early mechanical ventilation
Measured: From randomisation to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start5 Feb 2025
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 754 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr SZYCHOWIAK, MD, Study director, University Hospital, Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510972
- Sponsor's protocol ID
- DR230315
- Acronym
- JEUN-TUBE
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No