Skip to content

Cough Assessment in Patients With Severe Acquired Brain Injury

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02495558
Enrollment
30
Registered
2015-07-13
Start date
2015-10-31
Completion date
2016-07-31
Last updated
2015-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Brain Injury, Pneumonia, Tracheostomy Complication

Keywords

Cough Reflex test, Decannulation

Brief 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.

Detailed 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).

Interventions

OTHERReflex Cough Test

Peak of Cough Expiratory Flow of the reflex cough

Sponsors

IRCCS San Camillo, Venezia, Italy
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PCEF of the reflex cough8 weeksPeak of expiratory flow during reflex cough in patients with severe acquired brain injury

Secondary

MeasureTime frameDescription
PCEF of the reflex cough after decannulation9 weeksThe peak cough expiratory flow would be assessed after 96 hours post decannulation.

Countries

Italy

Contacts

Primary ContactIrene Battel
irene.battel@ospedalesancamillo.net+39 3395317706
Backup ContactNicolò Anesa
n.ricercaclinica@ospedalesancamillo.net+39-04122073765

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026