Cough Assessment in Patients With Severe Acquired Brain Injury

Study Overview
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Brief Summary
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The cough assessment is fundamental in the weaning process as it gives information on the possibility to expel food and secretion out from the airways. The majority of persons suffering from severe acquired brain injury are not able to cough voluntary due to severe cognitive deficit. In the present study, it would be evaluated the intensity of the reflex cough (RC) and the results would be correlated with weaning outcome.

Detailed Description
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All the participants will undergo firstly to the RC assessment. RC would be trigged by the inhalation of 0.4M of citric acid solution using the ultrasonic nebulizer (MO-03 Norditalia Elettromedicali). The face mask would be connected with the spirometer and the nebulizer via a bidirectional valve in order to measure Peak of Cough Expiratory Flow (PCEF) of the RC. Secondly, it would be assessed parameters of the weaning protocol in order to verify the feasible of removing the tracheostomy cannula. Hence, if the previous assessments are positive, the cannula 's patients would be removed. The follow-up would be taken after 96 hours from the decannulation in order to verify the outcome of weaning. In this study, it would be recruited a number of 30 consecutive patients admitted to IRCCS Ospedale San Camillo. The data would be firstly analyzed using Kolmogorov-Smirnov test in order to verify the distribution. Secondly it would be chosen to t-test for parametric outcomes or Wilcoxon non parametric outcomes. Thirdly, the correlation between the Peak of Cough Expiratory Flow of the RC and the weaning outcome would be completed using Pearson Test (parametric) or Spearman test (non parametric).

Official Title
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Pilot Study of the Cough Reflex Assessment in Patients With Tracheostomy Cannula Following Severe Acquired Brain Injury

Conditions
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Tracheostomy Complication, Acquired Brain Injury, Brain Injury, Pneumonia

Intervention / Treatment
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* Other: Reflex Cough Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of Acquired Brain Injury presence of tracheostomy cannula and positive cupping trial provide informed consent independently Exclusion Criteria: presence of allergy to citrus; presence of asthma presence of mechanical ventilation; presence of trachomalacia presence of laryngeal stenosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Tracheostomy<br>Assessment of reflex cough Assessment of the deccanultation outcome (follow-up) | Other: Reflex Cough Test<br>* Peak of Cough Expiratory Flow of the reflex cough<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCEF of the reflex cough | Peak of expiratory flow during reflex cough in patients with severe acquired brain injury | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCEF of the reflex cough after decannulation | The peak cough expiratory flow would be assessed after 96 hours post decannulation. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cough Reflex test, Decannulation