Cough Assessment in Patients With Severe Acquired Brain Injury

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02495558
Study type	Interventional
Source	IRCCS San Camillo, Venezia, Italy
Contact	Irene Battel
Phone	+39 3395317706
Email	irene.battel@ospedalesancamillo.net
Status	Recruiting
Phase	N/A
Start date	October 2015
Completion date	July 2016

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