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

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status and phase: Unknown; Phase 3

Conditions: Mechanical Ventilation Complication; Plug; Mucus; Tracheostomy Complication; Critical Illness

Treatments: Combination Product: Hypertonic saline of NaCl (7%) in combination with hyaluronic acid; Combination Product: Isotonic saline of NaCl (0,9%)

Study type: Interventional

Funder types: Other

Identifiers

NCT03870646

2018-11-1-HCUVA

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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164 participants in 2 patient groups, including a placebo group

Hypertonic saline

Experimental group

Description:

Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid

Treatment:

Combination Product: Hypertonic saline of NaCl (7%) in combination with hyaluronic acid

Isotonic saline

Placebo Comparator group

Description:

Nebulized isotonic saline of NaCl (0,9%)

Treatment:

Combination Product: Isotonic saline of NaCl (0,9%)