Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-13 @ 3:33 AM
Study NCT ID:
NCT02660203
Status:
UNKNOWN
Last Update Posted:
2018-11-15
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Forced Expiration On Pleural Drainage Duration (KPDP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-14', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-18', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of pleural drainage duration', 'timeFrame': '3 days', 'description': 'During the post-operative period until chest tube removal amount of pleural liquid drained is daily assessed.'}], 'secondaryOutcomes': [{'measure': 'assessment of total amount of pleural liquid drained', 'timeFrame': '3 days', 'description': 'Calculating cumulative volume of liquid provided by the drain (until it reaches 50 cc or less during the last day) during the post-operative period until chest tube removal'}, {'measure': 'Assessment of pain', 'timeFrame': '3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 5, 48', 'description': 'Pain scale score (EVENDOL 0 to 15)'}, {'measure': "patient's respiratory parameters", 'timeFrame': '3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48', 'description': 'level of oxygen dependency (L/min) during the post-operative period until chest tube removal'}, {'measure': 'paramedical workload', 'timeFrame': '3 days', 'description': 'Paramedical workload assessed by the time consumption (Hours) due to drainage tube'}, {'measure': 'Oxygen blood saturation', 'timeFrame': '3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48', 'description': 'Oxygen blood saturation (%) during the post-operative period until chest tube removal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chest physiotherapy', 'post operative period', 'forced expiration', 'pleural drainage duration'], 'conditions': ['Pulmonary Malformations', 'Child']}, 'descriptionModule': {'briefSummary': 'Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage.\n\nPleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy.\n\nForced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency.\n\nThe aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.', 'detailedDescription': 'Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage, most often for few days (2 to 5 days) until fluid quantity is lower than 50 mL / 24h.\n\nPleural effusion may cause pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude.\n\nRespiratory physiotherapy in such situations has different aims : pulmonary decongestion and reexpansion, aid for drainage and pleural fluid reduction, avoiding complications and preventing vicious attitudes.\n\nThese aims are learned in Physiotherapy formation institutes. The forced expiration technic in ipsilateral decubitus is justified by pleural physiology and is used after pediatric surgery without any scientific evidence regarding his efficacy Using pulmonary physiotherapy after pulmonary, mediastinal or pleural surgery for children is not systematic and depends on prescriber without any professional recommendation.\n\nActually no scientific evidence regarding technical or postural indicates improvement of effusion drainage.\n\nIt seems to be necessary to validate efficiency of such a technic and evaluate its consequences on post-operative pain. Furthermore, this pleural drainage impacts directly the duration of hospitalization and paramedical workload'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 0-4 years\n* In front have a mediastinum or lung surgery (lung segmentectomy or lobectomy or non anatomical lung resection) with pleural drainage, regardless of the type drain\n* Whose parents or the holder of parental authority have signed a consent\n* Whose parents or the holder of parental authority are affiliated to a social security scheme\n\nExclusion Criteria:\n\n* chest trauma\n* Oncology (chest tumors, lung metastases)\n* Drained Pleuropneumopathies\n* Spine Surgery\n* Heart surgery\n* Surgery for pectus excavatum\n* Route of anterior surgical approach sternotomy chest kind\n* Patients intubated and / or ventilated\n* Patients with preoperative sepsis'}, 'identificationModule': {'nctId': 'NCT02660203', 'acronym': 'KPDP', 'briefTitle': 'Impact of Forced Expiration On Pleural Drainage Duration (KPDP)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Tours'}, 'officialTitle': 'Impact of Ipsilateral Decubitus Forced Expiration On Duration of Pleural Drainage After Pulmonary Surgery in Children : Randomized Trial', 'orgStudyIdInfo': {'id': 'PHRIP-14/EC/KPDP'}, 'secondaryIdInfos': [{'id': '2015-A01549-40', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'forced expiration', 'description': '2 daily sessions of forced expiration on ipsilateral decubitus from day 1 after surgery until chest tube removal', 'interventionNames': ['Procedure: Forced expiration']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'No session of forced expiration'}], 'interventions': [{'name': 'Forced expiration', 'type': 'PROCEDURE', 'description': "Amongst chest physiotherapy technics, forced expiration is one of the passive procedures used in pediatrics.\n\nThe patient is positioned on ipsilateral decubitus and the physiotherapist is behind the patient, placing one hand on the patient abdomen and the other on the patient lateral chest. During expiration, the abdominal hand apply a pressure directed posteriorly and superiorly for the patient. Simultaneously, the thoracic hand apply a pressure posteriorly and inferiorly for the patient. The session's duration is 15 minutes after what the physiotherapist replace the patient in dorsal decubitus.Two sessions a day will be performed", 'armGroupLabels': ['forced expiration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49033', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stephane COUTURIER, Mr', 'role': 'CONTACT', 'email': 'stcouturier@chu-angers.fr', 'phone': '(33) 6 65 80 72 56'}, {'name': 'Guillaume PODEVIN, MD', 'role': 'CONTACT', 'email': 'GuPodevin@chu-angers.fr', 'phone': '(33) 2 41 35 42 95'}], 'facility': 'Uh Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29200', 'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine RAOUL, Mrs', 'role': 'CONTACT', 'email': 'catherine.raoul@chu-brest.fr'}, {'name': 'Philine DE VRIES, MD', 'role': 'CONTACT', 'email': 'philine.devries@chu-brest.fr'}], 'facility': 'UH BREST', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '69677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MULIER Catherine, Mrs', 'role': 'CONTACT', 'email': 'catherine.mulier@chu-lyon.fr', 'phone': '(33) 27855268'}, {'name': 'HAMEURY Frédéric, MD', 'role': 'CONTACT', 'email': 'frederic.hameury@chu-lyon.fr', 'phone': '(33) 427855938'}], 'facility': 'Hospices civiles Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '94140', 'city': 'Le Kremlin-Bicêtre', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'UH of PARIS - KREMLIN BICETRE Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '87000', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique PEJOAN, Mr', 'role': 'CONTACT', 'email': 'Dominique.Pejoan@chu-limoges.fr'}, {'name': 'Laurent FOURCADE, MD', 'role': 'CONTACT', 'email': 'Laurent.Fourcade@chu-limoges.fr'}], 'facility': 'Uh Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '13385', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'TOURNIE Brigitte, Mrs', 'role': 'CONTACT', 'email': 'Brigitte.TOURNIE@ap-hm.fr', 'phone': '(33) 623208504'}, {'name': 'BOUBNOVA Julia, MD', 'role': 'CONTACT', 'email': 'Julia.BOUBNOVA@ap-hm.fr', 'phone': '(33) 668723092'}], 'facility': 'UH Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ingrid CROSS, Mrs', 'role': 'CONTACT', 'email': 'ingris.cross@gmail.com', 'phone': '(33) 6 63 55 95 97'}, {'name': 'Stephan DE NAPOLI COCCI, MD', 'role': 'CONTACT', 'email': 'Stephan.DENAPOLICOCCI@chu-nantes.fr', 'phone': '(33) 2 40 08 33 33', 'phoneExt': '83 663'}], 'facility': 'Uh Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75.015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charles GRIMARD, Mr', 'role': 'CONTACT', 'email': 'charles.grimard@nck.aphp.fr'}, {'name': 'Naziha KHEN DUNLOP, MD', 'role': 'CONTACT', 'email': 'naziha.khen-dunlop@nck.aphp.fr', 'phone': '06 19 02 38 14'}], 'facility': 'UH of PARIS - NECKER Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'UH of PARIS - Robert Debre Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emilie CHICOISNE, Mrs', 'role': 'CONTACT', 'email': 'e.chicoisne@chu-tours.fr', 'phone': '(33) 2 47 47 47 47', 'phoneExt': '7 29 52'}, {'name': 'Michele Carriot, Mrs', 'role': 'CONTACT', 'email': 'm.carriot@chu-tours.fr', 'phone': '(33) 2 18 37 06 01'}, {'name': 'LARDY Hubert, MPh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UH Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Emilie CHICOISNE, Mrs', 'role': 'CONTACT', 'email': 'e.chicoisne@chu-tours.fr', 'phone': '(33) 2 47 47 47 47', 'phoneExt': '7. 29 52'}, {'name': 'Hubert LARDY, MD', 'role': 'CONTACT', 'email': 'hubert.lardy@univ-tours.fr', 'phone': '(33) 2 47 47 47 47', 'phoneExt': '7. 14 95'}], 'overallOfficials': [{'name': 'Emilie CHICOISNE, Mrs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH TOURS'}, {'name': 'Hubert LARDY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Tours'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Tours', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}