Continuation of Oral Intake Compared With Fasting in Patients With Acute Respiratory Failure Before Intubation : a Non-inferiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 754
- 试验地点
- 14
- 主要终点
- Percentage of patients intubated or dying without intubation within 96 hours of randomisation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Oral intake continuation strategy (Procedure)
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.
干预措施: Fasting strategy (Procedure)
结局指标
主要结局
Percentage of patients intubated or dying without intubation within 96 hours of randomisation
时间窗: From randomisation to 96 hours
次要结局
- Natraemia rates within 4 days of randomisation(From randomisation to day 4)
- Time from randomisation to intubation to Day 28(From randomisation to day 28)
- Occurrence of hypoglycaemia within 4 days of randomisation(From randomisation to day 4)
- 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)
- Immediate post-intubation salivary amylase and pepsin rates(Immediate post-intubation)
- Occurrence of acute renal failure within 4 days of randomisation(From randomisation to day 4)
- Occurrence of at least one pneumonia acquired under early mechanical ventilation(From randomisation to day 28)
- Occurrence of vomiting during intubation(Between the start and end of the intubation procedure)
- Occurrence of at least one nosocomial pneumonia within 28 days of randomisation(From randomisation to day 28)