Critical IllnessPhase 3NEBULANCT03870646
Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients
A Phase 3 study testing Hypertonic saline of NaCl (7%) in combination with hyaluronic acid and Isotonic saline of NaCl (0,9%) in people with Critical Illness and Tracheostomy Complication, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Tracheostomy Complication, Mechanical Ventilation Complication
- What is being tested?
- Hypertonic saline of NaCl (7%) in combination with hyaluronic acid and Isotonic saline of NaCl (0,9%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2019to 31 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years.
- Respiratory support through tracheostomy performed during ICU stay.
- Informed consent signed by the relatives or legal representative of the patient.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
About this study
Official title: 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.
- Conditions
- Critical Illness, Tracheostomy Complication, Mechanical Ventilation Complication, Plug; Mucus
- Being tested
- Hypertonic saline of NaCl (7%) in combination with hyaluronic acid, Isotonic saline of NaCl (0,9%)
- Keywords
- Critical Illness, Tracheostomy, Mechanical Ventilation, Complication, Plug, Mucus
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline of NaCl (7%) in combination with hyaluronic acidCombination product
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%)Combination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline | Experimental | Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid Receives: Combination Product: Hypertonic saline of NaCl (7%) in combination with hyaluronic acid |
| Isotonic saline | Placebo comparator | Nebulized isotonic saline of NaCl (0,9%) Receives: Combination Product: Isotonic saline of NaCl (0,9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before.
Secondary outcomes (5)
Length of mechanical ventilation
Number of days under mechanical ventilation
Measured: 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
Percentage of patients died during ICU stay
Measured: 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
Percentage of patients died during hospital stay
Measured: 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
Number of days admitted to the ICU
Measured: 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
Number of days admitted to the hospital
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unicentre, randomized, two arm, double-blind, controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen de la Arrixaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Alfonso Soler Barnés, Hospital Universitario Virgen de la Arrixaca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870646
- Sponsor's protocol ID
- 2018-11-1-HCUVA
- Acronym
- NEBULA
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized hypErtonic Saline for Better Prevention of mUcus pLug in Critical Adult Tracheostomized Patients (the NEBULA Study). A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03870646
- Acronym / sponsor ID
- NEBULA / 2018-11-1-HCUVA
- Conditions
- Critical Illness, Tracheostomy Complication, Mechanical Ventilation Complication, Plug; Mucus
- Keywords
- Critical Illness, Tracheostomy, Mechanical Ventilation, Complication, Plug, Mucus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen de la ArrixacaUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Unicentre, randomized, two arm, double-blind, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline | Experimental | Combination Product: Hypertonic saline of NaCl (7%) in combination with hyaluronic acidNebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid |
| Isotonic saline | Placebo comparator | Combination Product: Isotonic saline of NaCl (0,9%)Nebulized isotonic saline of NaCl (0,9%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years.
- Respiratory support through tracheostomy performed during ICU stay.
- Informed consent signed by the relatives or legal representative of the patient.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic saline of NaCl (7%) in combination with hyaluronic acidCritical 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. | Combination product | Hypertonic saline |
| 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. | Combination product | Isotonic saline |
Primary outcome
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.
5 secondary outcomes
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
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 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic saline of NaCl (7%) in combination with hyaluronic acid and Isotonic saline of NaCl (0,9%) in people with Critical Illness and Tracheostomy Complication, run by Hospital Universitario Virgen de la Arrixaca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.