Study Comparing Continuing Oral Intake Versus Fasting in Adults With Acute Respiratory Failure in Intensive Care

What this Trial Is About

Researchers are exploring the effects of continuing oral intake versus fasting in adult patients with acute respiratory failure in intensive care units who are not intubated. This trial aims to evaluate whether allowing patients to eat and drink before potential intubation affects the risk of intubation or aspiration-related complications. The study addresses a gap in knowledge as current guidelines lack data on nutritional management for these patients despite common fasting practices and frequent nutritional deficits. Participants are randomly assigned to one of two groups one group continues oral intake of liquids and solid foods without restrictions, supported by nursing assistance and regular oral care, while the other group follows a fasting protocol with no ingestion of food or liquids except minimal water for essential oral medications if needed. Both groups receive intravenous glucose or parenteral nutrition as necessary, and caloric intake is monitored. The study includes a 96-hour primary observation period after randomization. During the study, participants undergo assessments of respiratory status, nutritional intake, and discomfort levels such as thirst and hunger using verbal scales. Researchers monitor intubation rates, mortality, episodes of vomiting during intubation, salivary enzyme levels, and occurrences of pneumonia, renal failure, and hypoglycemia up to 28 days. The trial also tracks electrolyte levels and adverse events, with regular follow-up to evaluate safety and clinical outcomes over time.

Non-inferiority of Continuing Oral Intake Versus Fasting in Patients With Acute Respiratory Failure