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

Critical Illness Clinical Trial

— NEBULA  

Official title:

Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients (the NEBULA Study). A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03870646
• Other study ID #: 2018-11-1-HCUVA
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2019
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: December 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation Complication
• Plug; Mucus
• Postoperative Complications
• Tracheostomy Complication

Intervention

Combination Product:
• Hypertonic saline of NaCl (7%) in combination with hyaluronic acid
Critical adult tracheostomized patients will receive, in the intervention arm, nebulized Hypertonic saline of NaCl (7%) in combination with hyaluronic acid 5ml twice daily for 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before. The treatment will be applied through a jet nebulizer located in the inspiratory branch in patients under mechanical ventilation and in the sole tubulant of patients under T-piece oxygen regimen. Salbutamol 100 micrograms / dose, suspension for inhalation in pressure pack: 2 inhalations through the tracheostomy cannula 10 minutes before the application of the nebulization with hypersaline in order to avoid bronchospasm.
• Isotonic saline of NaCl (0,9%)
Critical adult tracheostomized patients will receive, in the control arm, nebulized isotonic saline of NaCl (0,9%) 5ml twice daily for 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before. The treatment will be applied through a jet nebulizer located in the inspiratory branch in patients under mechanical ventilation and in the sole tubulant of patients under T-piece oxygen regimen. Salbutamol 100 micrograms / dose, suspension for inhalation in pressure pack: 2 inhalations through the tracheostomy cannula 10 minutes before the application of the nebulization with isotonic saline in order to avoid bronchospasm.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen de la Arrixaca	El Palmar	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with mucus plug	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.	10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before.
Secondary	Length of mechanical ventilation	Number of days under 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
Secondary	Percentage of patients died during ICU stay	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
Secondary	Percentage of patients died during hospital 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
Secondary	ICU length of stay	Number of days admitted to the ICU	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
Secondary	Hospital length of stay	Number of days admitted to the hospital	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