Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT04685902
Status:
WITHDRAWN
Last Update Posted:
2022-03-07
First Post:
2020-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Staffing issues', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2020-12-21', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inspiratory flow from upper airway', 'timeFrame': "within 1 minute of measuring patient's inspiratory flow", 'description': 'Inspiratory flow from upper airway during one-way speaking valve trial'}, {'measure': 'Tidal volume from upper airway', 'timeFrame': "within 1 minute of measuring patient's tidal volume", 'description': 'Tidal volume from upper airway during one-way speaking valve trial'}, {'measure': 'Tran-tracheal pressure (TTP)', 'timeFrame': 'within 15 seconds of measuring TTP', 'description': 'Tran-tracheal pressure (TTP) during one-way speaking valve trial'}, {'measure': 'leak volume [for mechanically ventilated patients only]', 'timeFrame': "within 1 minute of measuring patient's leak volume", 'description': 'volume leaked from upper airway during invasive ventilation'}, {'measure': 'Ultrasound results for upper-airway', 'timeFrame': 'within 10 minutes of the ultrasound examination', 'description': 'Ultrasound results include pre-epiglottic space distance/epiglottitis to middle distance of vocal cords (Pre-E/E-VC), thyrohyoid membrane (DSEM), and hyomental distance ratio (HMDR)'}], 'secondaryOutcomes': [{'measure': 'Heart rate during one-way speaking valve trial', 'timeFrame': 'within 15 minutes of placing one-way speaking valve', 'description': 'Heart rate during one-way speaking valve trial'}, {'measure': 'Respiratory rate during one-way speaking valve trial', 'timeFrame': 'within 15 minutes of placing one-way speaking valve', 'description': 'Respiratory rate during one-way speaking valve trial'}, {'measure': 'SpO2 during one-way speaking valve trial', 'timeFrame': 'within 15 minutes of placing one-way speaking valve', 'description': 'SpO2 during one-way speaking valve trial'}, {'measure': 'Blood pressure during one-way speaking valve trial', 'timeFrame': 'within 15 minutes of placing one-way speaking valve', 'description': 'Blood pressure during one-way speaking valve trial'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tracheostomy', 'Upper airway patency', 'speaking valve', 'Ultrasound'], 'conditions': ['Tracheostomy Complication']}, 'referencesModule': {'references': [{'pmid': '24891198', 'type': 'RESULT', 'citation': 'Cheung NH, Napolitano LM. Tracheostomy: epidemiology, indications, timing, technique, and outcomes. Respir Care. 2014 Jun;59(6):895-915; discussion 916-9. doi: 10.4187/respcare.02971.'}, {'pmid': '20298366', 'type': 'RESULT', 'citation': 'Johnson DC, Campbell SL, Rabkin JD. Tracheostomy tube manometry: evaluation of speaking valves, capping and need for downsizing. Clin Respir J. 2009 Jan;3(1):8-14. doi: 10.1111/j.1752-699X.2008.00100.x.'}, {'pmid': '28649385', 'type': 'RESULT', 'citation': 'Singh RK, Saran S, Baronia AK. The practice of tracheostomy decannulation-a systematic review. J Intensive Care. 2017 Jun 20;5:38. doi: 10.1186/s40560-017-0234-z. eCollection 2017.'}, {'pmid': '29889671', 'type': 'RESULT', 'citation': 'Falcetta S, Cavallo S, Gabbanelli V, Pelaia P, Sorbello M, Zdravkovic I, Donati A. Evaluation of two neck ultrasound measurements as predictors of difficult direct laryngoscopy: A prospective observational study. Eur J Anaesthesiol. 2018 Aug;35(8):605-612. doi: 10.1097/EJA.0000000000000832.'}]}, 'descriptionModule': {'briefSummary': "Approximately 24% of ICU patients require the use of a tracheostomy, which impacts vocalization. A one-way speaking valve (SV) can be used to restore vocalization for this patient population. However, if a patient has an obstructed upper airway, SV placement has potential to pose a risk as it might cause asphyxia or even cardiac arrest within minutes, due to the sudden increased intra-thoracic pressure and decreased venous return. Therefore, upper airway patency is crucial in the patient's tolerability and safety to use SV. However, little is available to assess patient's upper airway patency before SV placement. Currently, the predominate way to evaluate readiness is the clinician's subjective assessment based on the quality of vocalization, perceived comfort, and tolerance following SV placement. In the previous in vitro study, the upper airway patency was strongly correlated with the trans-tracheal pressure and the inspiratory flow from upper airway during SV trial. Thus this clinical prospective observational study is aimed to validate the two methods with upper airway patency, which will be validated by bedside ultrasound examination as well."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial will be recruited from Rush University Medical Center, Chicago, IL.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Current RUMC patient\n* An order for a one-way speaking valve trial\n* Tracheostomy\n* PEEP ≤ 10 cm H2O and FIO2 ≤ 50%\n* English speaking\n\nExclusion Criteria:\n\n* Laryngectomy\n* Uncorrected anatomical anomalies\n* Unable to communicate\n* Hemodynamically unstable\n* Refuse to participate in the study'}, 'identificationModule': {'nctId': 'NCT04685902', 'briefTitle': 'Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Assessing Upper Airway Patency in Tracheostomy Patients During One Way Speaking Valve Trial', 'orgStudyIdInfo': {'id': 'Trach-PMV-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients with tracheostomy', 'description': 'Adult patients who currently have a tracheostomy and receive an order for one-way speaking valve trial', 'interventionNames': ['Device: One-way speaking valve']}], 'interventions': [{'name': 'One-way speaking valve', 'type': 'DEVICE', 'otherNames': ['Passy muir valve'], 'description': 'One-way speaking valve is a small device that attaches to the tracheostomy tube, to allows tracheostomy patient to breathe in through his or her trach tube. After the inhalation, the speaking valve closes. Air is breathed out (exhaled) up through the vocal cords, then through the mouth and nose.', 'armGroupLabels': ['Adult patients with tracheostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Jie Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to HIPAA, we would not share the individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jie Li', 'investigatorAffiliation': 'Rush University Medical Center'}}}}