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

Phase 3

• Conditions: Tracheostomy Complication; Mechanical Ventilation Complication; Critical Illness; Plug; Mucus
• Interventions: Combination Product: Hypertonic saline of NaCl (7%) in combination with hyaluronic acid; Combination Product: Isotonic saline of NaCl (0,9%)

• Registration Number: NCT03870646
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Study First Posted: 2019-03-12
• Last Update Posted: 2019-03-12
• Study Start: 2019-04-01
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline	Hypertonic saline of NaCl (7%) in combination with hyaluronic acid	Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid
Isotonic saline	Isotonic saline of NaCl (0,9%)	Nebulized isotonic saline of NaCl (0,9%)

Primary Outcome Measures

Name	Time	Method
Percentage of patients with mucus plug	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 Outcome Measures

Name	Time	Method
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	Number of days under mechanical ventilation
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 ICU stay
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	Percentage of patients died during hospital stay
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	Number of days admitted to the ICU
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	Number of days admitted to the hospital

Trial Locations

Locations (1)

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar, Murcia, Spain