Cough Assessment in Patients With Severe Acquired Brain Injury

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02495558
• Other study ID #: TRGCA
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2015
• Last updated: October 13, 2015
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2015
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: Irene Battel
• Phone: +39 3395317706
• Email: irene.battel[@]ospedalesancamillo.net
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Brain Injury
• Pneumonia
• Postoperative Complications
• Tracheostomy Complication

Intervention

Other:
• Reflex Cough Test
Peak of Cough Expiratory Flow of the reflex cough

Locations

Country	Name	City	State
Italy	Fondazione Ospedale San Camillo IRCCS	Venice

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Bittner EA, Schmidt UH. The ventilator liberation process: update on technique, timing, and termination of tracheostomy. Respir Care. 2012 Oct;57(10):1626-34. Review. — View Citation

McCool FD. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):48S-53S. Review. — View Citation

Miles 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCEF of the reflex cough	Peak of expiratory flow during reflex cough in patients with severe acquired brain injury	8 weeks	No
Secondary	PCEF of the reflex cough after decannulation	The peak cough expiratory flow would be assessed after 96 hours post decannulation.	9 weeks	No