Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients (the NEBULA Study). A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 164
- Locations
- 2
- Primary Endpoint
- Percentage of patients with mucus plug
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Masking Description
Identical vials for the intervention and control group
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Hypertonic saline
Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid
Intervention: Hypertonic saline of NaCl (7%) in combination with hyaluronic acid (Combination Product)
Isotonic saline
Nebulized isotonic saline of NaCl (0,9%)
Intervention: Isotonic saline of NaCl (0,9%) (Combination Product)
Outcomes
Primary Outcomes
Percentage of patients with mucus plug
Time Frame: 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before.
Mucus plug will be considered when there is a deterioration of the respiratory support accompanied by at least one of the following: * An inability to pass the aspiration catheter through the orotracheal tube or the tracheostomy tube. * Sudden hypoxia with physical and / or radiological examination compatible with atelectasis. * Need for urgent bronchoscopy with direct vision of the mucous plug.
Secondary Outcomes
- Length of mechanical ventilation(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)
- Percentage of patients died during ICU stay(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)
- Percentage of patients died during hospital stay(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)
- ICU length of stay(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)
- Hospital length of stay(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)
Investigators
Juan Alfonso Soler Barnés
Principal Investigator
Hospital Universitario Virgen de la Arrixaca