Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-02 @ 12:49 PM
Study NCT ID:
NCT06771232
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-13
First Post:
2024-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subdural intracranial pressure (sICP) mmHg', 'timeFrame': 'during the procedure', 'description': 'Change in sICP during an alveolar recruitment maneuver (ARM)'}], 'secondaryOutcomes': [{'measure': 'Pulmonary mechanics parameters', 'timeFrame': 'Intraoperative', 'description': 'To describe pulmonary mechanics parameters, including plateau pressure (cmH2O) and driving pressure.(cmH2O)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positive end expiratory pressure', 'intracranial pressure'], 'conditions': ['Intracranial Pressure Increase', 'Mechanical Ventilation Complication']}, 'descriptionModule': {'briefSummary': 'High positive end-expiratory pressure (PEEP) levels required to achieve clinical benefits may increase ICP and reduce cerebral perfusion pressure (CPP) in patients at risk of intracranial hypertension.\n\nHowever, individualizing ventilation parameters is essential for each patient. Among protective ventilation strategies, PEEP is key to preventing alveolar collapse. The PEEP level that minimizes alveolar collapse while avoiding overdistension of the pulmonary parenchyma is known as the Best PEEP. This study aims to evaluate the application of Best PEEP in cranial neurosurgery.', 'detailedDescription': 'In general anesthesia for neurosurgery, mechanical ventilation is the standard approach. However, mechanical ventilation can induce pulmonary parenchymal injury through various mechanisms, including volutrauma, barotrauma, and atelectrauma. These correspond to lung damage caused by high tidal volumes, elevated airway pressures, repetitive alveolar collapse, and reopening. Protective ventilation strategies include limiting tidal volume (Vt), applying positive end-expiratory pressure (PEEP), and performing alveolar recruitment maneuvers (ARM).\n\nHistorically, both ARM and higher levels of PEEP have been avoided in neurocritical patients, including those undergoing neurosurgery, due to concerns about their potential impact on intracranial pressure (ICP) and cerebral perfusion pressure (CPP). As postoperative pulmonary complications can significantly alter the prognosis of surgical patients, increasing hospital stay and healthcare costs, and, in neurocritical patients, compromising cerebral oxygenation, protective ventilation strategies may play a critical role in patients undergoing neurosurgery. Their historical exclusion from studies lacks demonstrated physiological justification.\n\nHere, the investigators aim to evaluate the impact of intrathoracic pressure on ICP in neurosurgical patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with intracranial disease undergoing elective intracranial surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA classification I-III.\n* Elective cranial neurosurgery.\n\nExclusion Criteria:\n\n* ASA classification IV or higher.\n* Documented intracranial hypertension.\n* Severe pulmonary disease (e.g., asthma, COPD).\n* Emergency surgery.'}, 'identificationModule': {'nctId': 'NCT06771232', 'briefTitle': 'Lung Recruitment and PEEP Effects on Intracranial Pressure in Cranial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Chile'}, 'officialTitle': 'Impact of Lung Recruitment Maneuvers and Positive End-Expiratory Pressure (PEEP) on Intracranial Pressure in Patients Undergoing Cranial Surgery', 'orgStudyIdInfo': {'id': 'OAIC 1463/24'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Subdural pressure measurement', 'type': 'PROCEDURE', 'otherNames': ['Alveolar recruitment maneuver and decremental PEEP titration'], 'description': 'Subdural intracranial pressure (SDIP) will observed during an alveolar recruitment maneuver and best PEEP titatration. SDIP will be measured while mechanical ventilation is maintained using the identified best PEEP.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8380456', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'contacts': [{'name': 'Felipe Maldonado', 'role': 'CONTACT'}, {'name': 'Roberto González', 'role': 'CONTACT'}], 'facility': 'Hospital Clínico de la Universidad de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'centralContacts': [{'name': 'Felipe Maldonado, M.D., M.Sc.', 'role': 'CONTACT', 'email': 'fmaldonado@uchile.cl', 'phone': '+56 2 2978 8221'}, {'name': 'Roberto González, M.D.', 'role': 'CONTACT', 'email': 'rgonzalezcor@gmail.com', 'phone': '+56 2 2978 8221'}], 'overallOfficials': [{'name': 'Felipe Maldonado, M.D., M.Sc.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Clinico de la Universidad de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chile', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}