Cough Assessment in Patients With Severe Acquired Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

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.

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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).

Conditions

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Tracheostomy Complication Acquired Brain Injury Brain Injury Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Patients with Tracheostomy

Assessment of reflex cough Assessment of the deccanultation outcome (follow-up)

Group Type EXPERIMENTAL

Reflex Cough Test

Intervention Type OTHER

Peak of Cough Expiratory Flow of the reflex cough

Interventions

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Reflex Cough Test

Peak of Cough Expiratory Flow of the reflex cough

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No