Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:21 PM
Study NCT ID:
NCT07473856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 146}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of readmissions with respiratory decompensation', 'timeFrame': '18 months after the index hospitalization with respiratory decompensation'}], 'secondaryOutcomes': [{'measure': 'Number of days of hospitalization', 'timeFrame': '18 months after the index hospitalization with respiratory decompensation.', 'description': 'Hospital days with respiratory decompensation in conventional service and in the intensive Care Unit'}, {'measure': 'Number and duration of respiratory exacerbations managed at home, emergency visits not followed by hospitalizations and unscheduled consultations', 'timeFrame': '18 months after the index hospitalization with respiratory decompensation.'}, {'measure': 'Number of days on antibiotics for respiratory issues', 'timeFrame': '18 months after the index hospitalization with respiratory decompensation.', 'description': 'Track antibiotic use for respiratory conditions outside of baseline treatment'}, {'measure': 'PolyQol scale', 'timeFrame': 'At month 1, month 3, month 6, month 12, and month 18', 'description': "change in the child's quality of life using the PolyQol scale"}, {'measure': 'PERKINE Questionnaire', 'timeFrame': 'At month 1, month 3, month 6, month 12, and month 18', 'description': "Evaluation of caregivers' perceptions of the child's respiratory status and the feasibility, tolerance, efficacy, and adherence to conventional respiratory physiotherapy versus PPV using the PERKINE questionnaire"}, {'measure': 'Cost-Effectiveness Analysis', 'timeFrame': 'At the end of the study', 'description': 'Evaluate the incremental cost-effectiveness ratio (ICER) of IPV at home compared to usual care cost'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polyhandicap', 'Intrapulmonary Percussive Ventilation', 'Respiratory distress', 'Rehospitalization with respiratory decompensation', 'Quality of life (PolyQol)', 'Exacerbation management at home'], 'conditions': ['Respiratory Decompensation', 'Multiple Disabilities']}, 'descriptionModule': {'briefSummary': 'Chronic respiratory failure is the leading cause of morbidity and mortality in children with multiple disabilities. Musculoskeletal disorders, swallowing disorders and ventilatory control abnormalities lead to progressive respiratory impairment, causing episodes of respiratory decompensation (RD). These are the leading cause of mortality (50 to 80%, average age of death: 21 years) and the cause of repeated hospitalizations.\n\nRespiratory care for these children is therefore a major challenge. In respiratory physiotherapy, this can be achieved through manual techniques and/or instrumental techniques such as intrapulmonary percussive ventilation (IPV), which is particularly useful in this population because it does not require active cooperation.\n\nThe main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV at home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone.This is a multicenter, randomized controlled superiority trial with two parallel groups.\n\nAll centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with respiratory decompensation (RD). After consent has been signed by the parents or legal guardians, the patient will be randomized into one of the two study groups:\n\n* Control group: manual respiratory physiotherapy.\n* Intervention group: intrapulmonary Percussive Ventilation (IPV)', 'detailedDescription': "IPV is used in France in different ways, depending on the center and service practices, as a complement to manual techniques.\n\nAt Armand Trousseau University Hospital, our experience over the past five years with more than 50 children suggests that the use of IPV by carers in their home environment. This is done as a complement to private manual physiotherapy sessions after training by a professional.\n\nHowever, the benefits and impact of IPV on patients' respiratory development remain largely unstudied, particularly in patients with multiple disabilities. This multicenter randomized controlled study could provide recommendations for the respiratory management of these patients.\n\nThe main objective of this study is to evaluate, in children with multiple disabilities, the effectiveness at 18 months of using an IPV in the home and by carers, combined with standard respiratory physiotherapy, compared with manual respiratory physiotherapy alone. The primary endpoint is the number of rehospitalizations for RD at 18 months following the index hospitalization.\n\nAll centers will recruit children aged 1 to 16 with multiple disabilities, during hospitalization with Respiratory Decompensation (RD). the patient will be randomized into one of the two study groups:\n\n* Control group:\n* Intervention group: the use of IPV will be initiated during hospitalization. The total duration of the study is planned to be 36 months, Follow-up visits will be scheduled at 1, 3, 6, 12 and 18 months for both groups. In order to avoid adding too many trips for these families, who are often very busy, visits will be scheduled at the same time as routine medical and paramedical consultations whenever possible. Certain visits that cannot be synchronized with routine follow-up consultations will be conducted via videoconference or telephone calls by the study investigators.\n\nAn adjudication committee will validate respiratory decompensation following rehospitalization that may occur within 18 months of the child's inclusion/randomization in the PERKINE protocol. They will remain blinded to the child's randomization group until the end of the study.\n\nAnalysis will be performed at the end of the study after data review and before database lock"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Polyhandicap defined by:\n\n * Causal brain injury or lesion occurring before the age of 3 years,\n * Severe or profound intellectual disability according to DSM IV definition\n * Motor disability: paraplegia/quadriplegia, hemiparesis, ataxia, and/or extrapyramidal motor disorders,\n * Gross Motor Function Classification System (GMFCS) score of IV or V,\n * Functional Independence Measure (FIM) score \\< 55,\n* Age: 1 to 16 years,\n* Hospitalization of the patient with respiratory decompensation (RD),\n* Informed consent from parents/legal guardians\n\nExclusion Criteria:\n\n* Associated neuromuscular disease\n* Daily use of intrapulmonary percussive ventilation for more than 3 consecutive months within the 6 months prior to inclusion,\n* Daily use of a cough assistance device such as an insufflator-exsufflator for more than 3 consecutive months within the 6 months prior to inclusion,\n* Contraindications for the use of the medical device:\n\n * Pneumothorax,\n * Hypotension or hemodynamic instability,\n * Hemoptysis,\n* Participation in another interventional study.\n* Patients with tracheobronchial collapse during expiration'}, 'identificationModule': {'nctId': 'NCT07473856', 'acronym': 'PERKINE', 'briefTitle': 'Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Long-term Use of Intrapulmonary Percussive Ventilation for Preventing Hospitalizations Due to Respiratory Decompensation in Children With Multiple Disabilities: A Multicenter Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'APHP240805'}, 'secondaryIdInfos': [{'id': 'IDRCB 2025-A01388-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPV + Manual Respiratory Physiotherapy', 'description': 'After the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home.', 'interventionNames': ['Procedure: Intrapulmonary Percussive Ventilation IPV']}, {'type': 'NO_INTERVENTION', 'label': 'Manual Respiratory Physiotherapy Only', 'description': 'no intervention, current practice'}], 'interventions': [{'name': 'Intrapulmonary Percussive Ventilation IPV', 'type': 'PROCEDURE', 'otherNames': ['Comfort Cough II®', 'Percussion Ventilation Device'], 'description': 'After the device has been adjusted to suit the child and carers have been trained during hospitalisation, IPV will be prescribed for use by carers at home for 15 minutes, five times a week, in addition to manual RP prescribed 2 to 3 times a week in private practice or at home.', 'armGroupLabels': ['IPV + Manual Respiratory Physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Jessica TAYTARD, MCU-PH', 'role': 'CONTACT', 'email': 'jessica.taytard@aphp.fr', 'phone': '+33 (0)1 71 73 87 11'}, {'name': 'Charlotte THEBAULT', 'role': 'CONTACT', 'email': 'charlotte.thebault@aphp.fr', 'phone': '00 33 6.65.80.72.55'}], 'facility': 'Name Pediatric Pulmonology Department - Armand Trousseau Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Jessica TAYTARD, MCU-PH', 'role': 'CONTACT', 'email': 'jessica.taytard@aphp.fr', 'phone': '+33 (0)1 71 73 87 11'}, {'name': 'Elsa SCHWARTZ', 'role': 'CONTACT', 'email': 'elsa.schwartz@aphp.fr', 'phone': '00 33 1 71 73 80 26'}], 'overallOfficials': [{'name': 'Jessica TAYTARD, MCU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}