An interventional study of Oral intake continuation strategy and Fasting strategy in Respiratory Insufficiency, Fasting and Dysphagia, sponsored by University Hospital, Tours. Recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Supportive care
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.
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.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 754 is above the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Criteria for acute hypoxaemic respiratory failure defined as.
Exclusion Criteria:
Patient with criteria for immediate intubation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
The patient will not be able to ingest liquids or solid food.
Percentage of patients intubated or dying without intubation within 96 hours of randomisation
Time frame: From randomisation to 96 hours
Simple verbal scale between 1 and 4 of sensation of thirst and hunger at D1 after randomisation
Time frame: At Day 1 after randomisation
Mortality at D28
Time frame: At Day 28
Time from randomisation to intubation to Day 28
Time frame: From randomisation to day 28
Occurrence of vomiting during intubation
Time frame: Between the start and end of the intubation procedure
Immediate post-intubation salivary amylase and pepsin rates
Time frame: Immediate post-intubation
Natraemia rates within 4 days of randomisation
Time frame: From randomisation to day 4
Occurrence of acute renal failure within 4 days of randomisation
Time frame: From randomisation to day 4
Occurrence of hypoglycaemia within 4 days of randomisation
Time frame: From randomisation to day 4
Occurrence of at least one nosocomial pneumonia within 28 days of randomisation
Time frame: From randomisation to day 28
Occurrence of at least one pneumonia acquired under early mechanical ventilation
Time frame: From randomisation to day 28
Started Feb 2025 (actual). Primary completion is estimated for Feb 2028, 36 months after the start.
Of 359 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 36 months is above that.
Counting every sponsor, half of 375 studies reached it within 24 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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