Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS) in the Intensive Care Unit: Protocol of a Prospective Cohort Study.

ABSTRACT

Aims: The Post-extubation Assessment of Laryngeal Symptoms and Severity (PALSS) study systematically evaluates patient symptoms related to endotracheal intubation with mechanical ventilation, assesses laryngeal injury and voice function after extubation, and develops a screening tool to identify patients with clinically important, post-extubation laryngeal injury. Design: Single-center, prospective observational cohort study conducted in 6 intensive care units (ICU). Methods: Patients ≥18 years old who are orally intubated and mechanically ventilated in an ICU and meet eligibility criteria will undergo flexible laryngoscopy, with a sample size goal of 300 completed laryngoscopies. Primary outcome measures include signs and symptoms of laryngeal injury, including voice symptoms and alterations in swallowing, measured using the Laryngeal Hypersensitivity Questionnaire-Acute and Voice Symptom Scale questionnaires respectively. Data will be collected within 72 hours post-extubation and at 7-day follow-up or hospital discharge (whichever occurs first). Data will be analyzed using descriptive statistics, regression models, and predictive modeling using machine learning. Discussion: The findings of this study will describe the clinical signs and symptoms of laryngeal injury post-extubation. Conclusion: The PALSS study will provide insights for future studies that explore laryngeal injuries using flexible laryngoscopy after endotracheal intubation. Implications for patient care Identifying signs and symptoms of laryngeal injury after endotracheal intubation will facilitate the development of a screening tool that will assist in early identification of post-extubation laryngeal injury, and aid in decreasing short- and long-term complications of endotracheal intubation. Reporting Method: SPIRIT. Patient or Public Contribution Patients were study participants; and family members provided informed consent when the patient lacked decision-making capacity.