Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-25 @ 9:46 PM
Study NCT ID:
NCT02495558
Status:
UNKNOWN
Last Update Posted:
2015-10-14
First Post:
2015-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cough Assessment in Patients With Severe Acquired Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2015-07-02', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCEF of the reflex cough', 'timeFrame': '8 weeks', 'description': 'Peak of expiratory flow during reflex cough in patients with severe acquired brain injury'}], 'secondaryOutcomes': [{'measure': 'PCEF of the reflex cough after decannulation', 'timeFrame': '9 weeks', 'description': 'The peak cough expiratory flow would be assessed after 96 hours post decannulation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cough Reflex test', 'Decannulation'], 'conditions': ['Tracheostomy Complication', 'Acquired Brain Injury', 'Brain Injury', 'Pneumonia']}, 'referencesModule': {'references': [{'pmid': '8989078', 'type': 'BACKGROUND', 'citation': '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': '23013900', 'type': 'BACKGROUND', '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. doi: 10.4187/respcare.01914.'}, {'pmid': '16428691', 'type': 'BACKGROUND', 'citation': 'McCool 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': '22873621', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of Acquired Brain Injury\n* presence of tracheostomy cannula and positive cupping trial\n* provide informed consent independently\n\nExclusion Criteria:\n\n* presence of allergy to citrus;\n* presence of asthma\n* presence of mechanical ventilation;\n* presence of trachomalacia\n* presence of laryngeal stenosis'}, 'identificationModule': {'nctId': 'NCT02495558', 'briefTitle': 'Cough Assessment in Patients With Severe Acquired Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Camillo, Venezia, Italy'}, 'officialTitle': 'Pilot Study of the Cough Reflex Assessment in Patients With Tracheostomy Cannula Following Severe Acquired Brain Injury', 'orgStudyIdInfo': {'id': 'TRGCA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Tracheostomy', 'description': 'Assessment of reflex cough Assessment of the deccanultation outcome (follow-up)', 'interventionNames': ['Other: Reflex Cough Test']}], 'interventions': [{'name': 'Reflex Cough Test', 'type': 'OTHER', 'description': 'Peak of Cough Expiratory Flow of the reflex cough', 'armGroupLabels': ['Patients with Tracheostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20126', 'city': 'Venice', 'state': 'Venice', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Irene Battel', 'role': 'CONTACT', 'email': 'irene.battel@gmail.com', 'phone': '3395317706'}], 'facility': 'Fondazione Ospedale San Camillo IRCCS', 'geoPoint': {'lat': 45.43713, 'lon': 12.33265}}], 'centralContacts': [{'name': 'Irene Battel', 'role': 'CONTACT', 'email': 'irene.battel@ospedalesancamillo.net', 'phone': '+39 3395317706'}, {'name': 'Nicolò Anesa', 'role': 'CONTACT', 'email': 'n.ricercaclinica@ospedalesancamillo.net', 'phone': '+39-04122073765'}], 'overallOfficials': [{'name': 'Claudia Enrichi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'claudia.enrichi@ospedalesancamillo.net'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Camillo, Venezia, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Speech and Language Therapist', 'investigatorFullName': 'Irene Battel', 'investigatorAffiliation': 'IRCCS San Camillo, Venezia, Italy'}}}}