- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03870646
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
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
-
-
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
|
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%)
|
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:
|
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.
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
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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