Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-28 @ 7:26 AM
Study NCT ID:
NCT07061561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive Value of Peak Expiratory Flow (PEF) Measured Before Decannulation for PEF After Decannulation in Tracheotomized Patients.', 'timeFrame': 'From pre-decannulation measurement (up to 7 days before) to 72 hours after decannulation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tracheostomy', 'Cough', 'Weaning', 'Respiratory Function Tests', 'Diaphragm']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate how well tracheotomized patients can cough before and after their tracheostomy tube is removed. Cough strength is measured using two different tools-Peak Flow and Lorio. Researchers want to find out if the cough measurement taken before removing the tube can help predict how effective the patient's cough will be afterward. The study will also explore factors that might influence cough strength and compare the usefulness of the two tools. Additionally, it will assess how patients feel about using these devices and the role of diaphragm ultrasound in predicting cough effectiveness."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 years or older)\n* Hospitalized in post-intensive care rehabilitation unit (SRPR) or intensive care unit (ICU)\n* Tracheotomized during the weaning process\n* Medical prescription for physiotherapy assessment\n* Medical prescription for speech therapy assessment\n\nExclusion Criteria:\n\n* Patients who have undergone total laryngectomy\n* Patients with severe swallowing disorders\n* Patients with cognitive impairments incompatible with understanding instructions\n* Patients under medical decision to stop active treatments\n* Patients who refuse to participate or refuse to sign informed consent\n* Patients under guardianship or curatorship\n* Patients not affiliated with a social security scheme'}, 'identificationModule': {'nctId': 'NCT07061561', 'briefTitle': 'Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Saint-Denis'}, 'officialTitle': 'Objective Evaluation of Cough Effort in Tracheotomized Patients (LOST Study)', 'orgStudyIdInfo': {'id': '0095_KINESITHERAPIE_LOST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Group - Cough Effort Measurement and Follow-Up', 'interventionNames': ['Device: Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device']}], 'interventions': [{'name': 'Peak Expiratory Flow Measurement Using Peak Flow Meter and Lorio Device', 'type': 'DEVICE', 'description': 'This intervention involves the use of two respiratory measurement devices to assess cough strength in tracheotomized patients: the traditional Peak Flow meter, which measures peak expiratory flow (PEF), and the Lorio device, a novel tool designed for respiratory rehabilitation with customizable training exercises. Measurements are taken at multiple time points before and after decannulation to compare accuracy, reproducibility, and patient usability.', 'armGroupLabels': ['Single Group - Cough Effort Measurement and Follow-Up']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Saint-Denis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}