Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-03-10 @ 11:37 PM
Study NCT ID:
NCT03609866
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2018-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chest Physiotherapy Effects on Intracranial Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-22', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intracranial pressure changes', 'timeFrame': '5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure', 'description': 'with Camino ICP monitoring'}], 'secondaryOutcomes': [{'measure': 'oxygen saturation changes', 'timeFrame': '5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure', 'description': 'with philips monitoring device'}, {'measure': 'peak expiratory flow changes', 'timeFrame': 'all the respiratory cycles will be recorded 30 seconds before procedure and during the procedure', 'description': 'with maquet servo u and servo i ventilators, the purpose is to identify the best peak expiratory flow before and during the procedure, and to compare them.'}, {'measure': 'heart rate changes', 'timeFrame': '5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure', 'description': 'with philips monitoring device'}, {'measure': 'cerebral perfusion pressure changes', 'timeFrame': '5 minutes before start procedure, immediately after procedure, 5 minutes after the end of procedure and 10 minutes after the end of procedure', 'description': 'with philips monitoring device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intracranial pressure increase', 'chest physiotherapy', 'ventilated patients', 'mechanical ventilation'], 'conditions': ['Acute Brain Injury']}, 'referencesModule': {'references': [{'pmid': '40270039', 'type': 'DERIVED', 'citation': 'Rodrigues-Gomes RM, Prieto Campo A, Martinez Rolan R, Gelabert-Gonzalez M. Effects of rapid chest compression technique on intracranial and cerebral perfusion pressures in acute neurocritical patients: a randomized controlled trial. Crit Care. 2025 Apr 23;29(1):159. doi: 10.1186/s13054-025-05405-8.'}, {'pmid': '35428364', 'type': 'DERIVED', 'citation': 'Rodrigues-Gomes RM, Marti JD, Rolan RM, Gelabert-Gonzalez M. Rapid chest compression effects on intracranial pressure in patients with acute cerebral injury. Trials. 2022 Apr 15;23(1):312. doi: 10.1186/s13063-022-06189-w.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will study the effects of a chest physiotherapy technique (rapid thoracic compression) on the intracranial pressure of individuals with acute cerebral injury and with need of intubated mechanical ventilation', 'detailedDescription': 'Patients with acute brain injury often require invasive mechanical ventilation connection, increasing the risk of developing complications such as respiratory secretions retention. Thethoracic compression is a manual chest physiotherapy technique that can improve clearance of secretions in these patients. Although today the scientific evidence is contradictory, the manual abdomino-thoracic compression may be associated with increased intracranial pressure in patients with acute brain injury.\n\nObjectives: The aim of this work to study the effects of manual thoracic compression technique in intracranial pressure in mechanically ventilated patients. Furthermore, the effects of the technique in different volumes and flows recorded by the ventilator and the relationship between the pressure applied in the intervention group and the different variables will also be studied.\n\nMethodology: It will be a randomized clinical trial, single-blind in the application of the techniques. Patients with acute brain injury in invasive mechanical ventilation will be included, randomized into two groups. In the control group, a technique of passive inferior limbs mobilization will be applied and in the intervention group it will be performed the manual thoracic compression technique. The data of the primary variable, intracranial pressure will be collected with a monitoring system and continuous recording (Integra Camino).\n\nA descriptive analysis of the values collected from the variables in the study will be performed, studying the measures of central tendency. In the presence of normal distribution will be presented mean and standard deviation, and median and interquartile range in case of non-observation of normal distribution. The normality of the samples will be verified with the Kolmogorov-Smirnov test. The verification of the hypothesis in study will be assessed using the Student T test for independent samples in case of sample normality and by the Wilcoxon test otherwise. A multiple linear regression analysis will be performed: considering as a dependent variable the differences in intracranial pressure, difference or volume / minute gain and expiratory flow and between the covariates, the type of technique, the pressure applied in the technique under study, the type of brain injury, age, sex, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intubated patients for 48 hours in vc, pc, vcrp\n* hemodynamically stable (MAP\\>60mmHg)\n* respiratory stability (PEEP\\<15cmH2O and FiO2\\<60%)\n* ICP stable (0\\<icp\\<20mmHg)\n* RASS of 5\n* informed consent signed\n\nExclusion Criteria:\n\n* thoracic fractures\n* abdominal injuries that limits local pressure\n* systemic or local changes that undergoes with abdominal volume increase\n* inferior limbs fractures that contraindicates passive mobilization techniques'}, 'identificationModule': {'nctId': 'NCT03609866', 'briefTitle': 'Chest Physiotherapy Effects on Intracranial Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of Santiago de Compostela'}, 'officialTitle': 'the Effects of Manual Thoracic Compression Technique in Intracranial Pressure in Mechanically Ventilated Patients With Acute Cerebral Injury', 'orgStudyIdInfo': {'id': 'Usantiago Doct'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'will be performed inferior limbs passive mobilization', 'interventionNames': ['Procedure: inferior limb passive mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'rapid thoracic compression technique will be applied', 'interventionNames': ['Procedure: rapid thoracic compression technique']}], 'interventions': [{'name': 'rapid thoracic compression technique', 'type': 'PROCEDURE', 'description': 'in the expiratory time of the ventilation set, it will be applied a rapid thoracic compression', 'armGroupLabels': ['experimental']}, {'name': 'inferior limb passive mobilization', 'type': 'PROCEDURE', 'description': 'it will be performed a passive mobilization technique on the patient', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36312', 'city': 'Vigo', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}], 'overallOfficials': [{'name': 'ricardo m rodrigues gomes, PT MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Santiago de Compostela'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Santiago de Compostela', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'ricardo miguel rodrigues gomes', 'investigatorAffiliation': 'University of Santiago de Compostela'}}}}