Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients (NEBULA)
Primary Purpose
Critical Illness, Tracheostomy Complication, Mechanical Ventilation Complication
Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Hypertonic saline of NaCl (7%) in combination with hyaluronic acid
Isotonic saline of NaCl (0,9%)
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness focused on measuring Critical Illness, Tracheostomy, Mechanical Ventilation, Complication, Plug, Mucus
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario Virgen de la Arrixaca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hypertonic saline
Isotonic saline
Arm Description
Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid
Nebulized isotonic saline of NaCl (0,9%)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Length of mechanical ventilation
Number of days under mechanical ventilation
Percentage of patients died during ICU stay
Percentage of patients died during ICU stay
Percentage of patients died during hospital stay
Percentage of patients died during hospital stay
ICU length of stay
Number of days admitted to the ICU
Hospital length of stay
Number of days admitted to the hospital
Full Information
NCT ID
NCT03870646
First Posted
March 4, 2019
Last Updated
March 8, 2019
Sponsor
Hospital Universitario Virgen de la Arrixaca
1. Study Identification
Unique Protocol Identification Number
NCT03870646
Brief Title
Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Tracheostomy Complication, Mechanical Ventilation Complication, Plug; Mucus
Keywords
Critical Illness, Tracheostomy, Mechanical Ventilation, Complication, Plug, Mucus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Unicentre, randomized, two arm, double-blind, controlled trial.
Masking
ParticipantCare Provider
Masking Description
Identical vials for the intervention and control group
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypertonic saline
Arm Type
Experimental
Arm Description
Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid
Arm Title
Isotonic saline
Arm Type
Placebo Comparator
Arm Description
Nebulized isotonic saline of NaCl (0,9%)
Intervention Type
Combination Product
Intervention Name(s)
Hypertonic saline of NaCl (7%) in combination with hyaluronic acid
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Isotonic saline of NaCl (0,9%)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of patients with mucus plug
Description
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.
Time Frame
10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before.
Secondary Outcome Measure Information:
Title
Length of mechanical ventilation
Description
Number of days under 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
Title
Percentage of patients died during ICU stay
Description
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
Title
Percentage of patients died during hospital stay
Description
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
Title
ICU length of stay
Description
Number of days admitted to the ICU
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
Title
Hospital length of stay
Description
Number of days admitted to the hospital
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients
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