Tracheostomy ComplicationNCT02495558
Cough Assessment in Patients With Severe Acquired Brain Injury
A study testing Reflex Cough Test in people with Tracheostomy Complication and Acquired Brain Injury, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tracheostomy Complication, Acquired Brain Injury, Brain Injury
- What is being tested?
- Reflex Cough Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of Acquired Brain Injury
- presence of tracheostomy cannula and positive cupping trial
- provide informed consent independently
Who cannot join
- presence of allergy to citrus;
- presence of asthma
- presence of mechanical ventilation;
- presence of trachomalacia
- presence of laryngeal stenosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Ospedale San Camillo IRCCS
Venice, Venice, 20126
Irene Battel, 3395317706, irene.battel@gmail.com
About this study
Official title: Pilot Study of the Cough Reflex Assessment in Patients With Tracheostomy Cannula Following Severe Acquired Brain Injury
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.
Read the 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).
- Being tested
- Reflex Cough Test
- Keywords
- Cough Reflex test, Decannulation
- Medical subject headings
- Brain Injuries, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflex Cough TestOther
Peak of Cough Expiratory Flow of the reflex cough
| Study group | Role | What they receive |
|---|---|---|
| Patients with Tracheostomy | Experimental | Assessment of reflex cough Assessment of the deccanultation outcome (follow-up) Receives: Other: Reflex Cough Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCEF of the reflex cough
Peak of expiratory flow during reflex cough in patients with severe acquired brain injury
Measured: 8 weeks
Secondary outcomes (1)
PCEF of the reflex cough after decannulation
The peak cough expiratory flow would be assessed after 96 hours post decannulation.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2015
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tracheostomy ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Battel, IRCCS San Camillo, Venezia, Italy
- Investigators
- Claudia Enrichi, Principal investigator, claudia.enrichi@ospedalesancamillo.net
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495558
- Sponsor's protocol ID
- TRGCA
- Status last verified
- Oct 2015
- First submitted
- 2 Jul 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 8989078Bittner 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.
PubMed 23013900McCool 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.
PubMed 16428691Miles 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.
PubMed 22873621
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Cough Reflex Assessment in Patients With Tracheostomy Cannula Following Severe Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02495558
- Acronym / sponsor ID
- TRGCA
- Keywords
- Cough Reflex test, Decannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Tracheostomy | Experimental | Other: Reflex Cough TestAssessment of reflex cough Assessment of the deccanultation outcome (follow-up) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of Acquired Brain Injury
- presence of tracheostomy cannula and positive cupping trial
- provide informed consent independently
Key exclusion criteria (5 listed)
- presence of allergy to citrus;
- presence of asthma
- presence of mechanical ventilation;
- presence of trachomalacia
- presence of laryngeal stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reflex Cough TestPeak of Cough Expiratory Flow of the reflex cough | Other | Patients with Tracheostomy |
Primary outcome
PCEF of the reflex cough
Time frame: 8 weeks
Peak of expiratory flow during reflex cough in patients with severe acquired brain injury
1 secondary outcome
PCEF of the reflex cough after decannulation
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 8989078Bach 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.
- Background: PubMed 23013900Bittner 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.
- Background: PubMed 16428691McCool 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.
- Background: PubMed 22873621Miles 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Enrichi principal investigator
claudia.enrichi@ospedalesancamillo.net
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reflex Cough Test in people with Tracheostomy Complication and Acquired Brain Injury, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Battel (+39 3395317706, irene.battel@ospedalesancamillo.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCEF of the reflex cough (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495558, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.