drugset / Trial / NCT03870646

Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients

NCT03870646

Phase 3 Unknown 164 enrolled Hospital Universitario Virgen de la Arrixaca
RandomizedParallel-groupDouble-blindPrevention

Summary

Tracheostomy is an important tool in the management of respiratory failure in the critically ill patient under mechanical ventilation. Although mechanical ventilation can be a lifesaving intervention, it is also known to carry several side-effects and risks. Among the most frequent complications of mechanical ventilation, obstruction of the airway secondary to a mucus plug is both life threatening and a prevalent phenomenon related to mucociliary system dysfunction, artificial airway itself and the loss of strength that prevents adequate airway clearance. The main indication of tracheostomy is the need for prolonged mechanical ventilation that usually occurs in more severe patients, this circumstance having also been related to the development of intensive care unit (ICU) acquired weakness. Currently, the approach to secretion clearance in critical patients is focused on rehabilitation therapy and humidification. Hypertonic saline (HS) is largely used in cystic fibrosis to increase airways clearance while little evidence is available in other settings although promising results have been reported. In this sense, the use of HS could be beneficial in the prevention of airway obstruction in tracheostomized critical patients.

Timeline

Start
2019-04-01
Primary completion
2020-10-31
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Hyaluronic Acid Other / unclassified Inhaled
Subject NaCl Unknown 5 ml Inhaled