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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
July 13, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedOctober 14, 2015
October 1, 2015
Same day
July 2, 2015
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PCEF of the reflex cough
Peak of expiratory flow during reflex cough in patients with severe acquired brain injury
8 weeks
Secondary Outcomes (1)
PCEF of the reflex cough after decannulation
9 weeks
Study Arms (1)
Patients with Tracheostomy
EXPERIMENTALAssessment of reflex cough Assessment of the deccanultation outcome (follow-up)
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of Acquired Brain Injury
- presence of tracheostomy cannula and positive cupping trial
- provide informed consent independently
You may not qualify if:
- presence of allergy to citrus;
- presence of asthma
- presence of mechanical ventilation;
- presence of trachomalacia
- presence of laryngeal stenosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Ospedale San Camillo IRCCS
Venice, Venice, 20126, Italy
Related Publications (4)
Bach JR, Saporito LR. Criteria for extubation and tracheostomy tube removal for patients with ventilatory failure. A different approach to weaning. Chest. 1996 Dec;110(6):1566-71. doi: 10.1378/chest.110.6.1566.
PMID: 8989078BACKGROUNDBittner EA, Schmidt UH. The ventilator liberation process: update on technique, timing, and termination of tracheostomy. Respir Care. 2012 Oct;57(10):1626-34. doi: 10.4187/respcare.01914.
PMID: 23013900BACKGROUNDMcCool FD. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):48S-53S. doi: 10.1378/chest.129.1_suppl.48S.
PMID: 16428691BACKGROUNDMiles A, Huckabee ML. Intra- and inter-rater reliability for judgement of cough following citric acid inhalation. Int J Speech Lang Pathol. 2013 Apr;15(2):209-15. doi: 10.3109/17549507.2012.692812. Epub 2012 Aug 8.
PMID: 22873621BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia Enrichi
claudia.enrichi@ospedalesancamillo.net
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Speech and Language Therapist
Study Record Dates
First Submitted
July 2, 2015
First Posted
July 13, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2015
Study Completion
July 1, 2016
Last Updated
October 14, 2015
Record last verified: 2015-10