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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic saline | Experimental | Nebulized hypertonic saline of NaCl (7%) in combination with hyaluronic acid |
|
| Isotonic saline | Placebo Comparator | Nebulized isotonic saline of NaCl (0,9%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline of NaCl (7%) in combination with hyaluronic acid | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of patients died during ICU stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
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Unicentre, randomized, two arm, double-blind, controlled trial.
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Identical vials for the intervention and control group
|
| 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. |
|
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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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