Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-25 @ 7:02 PM
Study NCT ID:
NCT01991535
Status:
WITHDRAWN
Last Update Posted:
2024-03-21
First Post:
2013-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D010845', 'term': 'Obesity Hypoventilation Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007040', 'term': 'Hypoventilation'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2013-11-18', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcutaneous carbon dioxide measurement', 'timeFrame': 'One hour'}], 'secondaryOutcomes': [{'measure': 'Inspiratory-time/total-respiratory-cycle value', 'timeFrame': 'One hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neuromuscular Disorders', 'Chest Wall Disorders', 'Obesity Hypoventilation Syndrome (OHS)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.', 'detailedDescription': 'Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation).\n* Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious.\n* Clinically stable (within the previous month).\n* Patients without previous NonInvasive Mechanical Ventilation treatment.\n\nExclusion Criteria:\n\n* Clinical exacerbation.\n* Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio \\< 70% or Sleep Apnea-Hypopnea Syndrome'}, 'identificationModule': {'nctId': 'NCT01991535', 'briefTitle': 'Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern', 'orgStudyIdInfo': {'id': 'IIBSP-VEN-2013-23'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spontaneous Ventilation Mode', 'type': 'DEVICE', 'description': 'Respiratory rate and duration of inspiration are controlled by the patient.\n\nDevice model: Stellar 150® (ResMed, Australia).'}, {'name': 'Controlled Ventilation Mode', 'type': 'DEVICE', 'description': 'Ventilator maintains the positive end-expiratory pressure until the patient inspires. At that point, the ventilator reaches the support pressure in a predetermined time. The patient fixes the respiratory rate and the duration of inspiration, triggering all the cycles.\n\nDevice model: Stellar 150® (ResMed, Australia).'}, {'name': 'Simulator Ventilation Mode', 'type': 'DEVICE', 'description': 'Ventilator maintains a continuous positive airway pressure during the entire cycle.\n\nDevice model: Stellar 150® (ResMed, Australia).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Pedro A Anton Albisu, Medical Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau"}, {'name': 'Patricia Peñacoba Toribio, Physician', 'role': 'STUDY_CHAIR', 'affiliation': "Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau"}, {'name': 'Macarena Segura, Physiotherapist', 'role': 'STUDY_CHAIR', 'affiliation': "Fundacio Gestio Sanitaria de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}