Clinical trial NCT03870646: Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients
Official title: Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients (the NEBULA Study). A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Critical Illness
Tracheostomy Complication
Mechanical Ventilation Complication
Plug; Mucus
Keywords: Critical Illness
Tracheostomy
Mechanical Ventilation
Complication
Plug
Mucus
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unicentre, randomized, two arm, double-blind, controlled trial.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years.
* Respiratory support through tracheostomy performed during ICU stay.
* Informed consent signed by the relatives or legal representative of the patient.

Exclusion Criteria:

* Pregnancy.
* Any terminal disease.
* Known hypersensitivity to any component of Hyaneb (Hypertonic saline of NaCl (7%) in combination with hyaluronic acid).
* Participation in another research study.
* Any other condition that, according to the investigator, may prevent a participant to complete all the procedures required.

Primary outcomes:
measure: Percentage of patients with mucus plug
timeFrame: 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before.
Secondary outcomes:
measure: Length of mechanical ventilation
timeFrame: From the start date of mechanical ventilation to the date of its withdrawal or date of death from any cause, whichever came first, assessed up to 12 months
measure: Percentage of patients died during ICU stay
timeFrame: From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 12 months
measure: Percentage of patients died during hospital stay
timeFrame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 15 month
measure: ICU length of stay
timeFrame: From date of ICU admission until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 12 month
measure: Hospital length of stay
timeFrame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 15 month
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
Study officials:
References: