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

March 8, 2019 updated by: Juan Alfonso Soler Barnés, Hospital Universitario Virgen de la Arrixaca

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

164

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen de La Arrixaca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypertonic saline
Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid
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.
Placebo Comparator: Isotonic saline
Nebulized isotonic saline of NaCl (0,9%)
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of mechanical ventilation
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-11-1-HCUVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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