Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-02-20 @ 1:19 AM
Study NCT ID:
NCT06212258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-18
First Post:
2024-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2024-01-08', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pneumoperitoneum increases mean expiratory flow rate', 'timeFrame': 'during surgery', 'description': 'Elevated intraabdominal pressure leads to a decrease in respiratory compliance and an increase in peak inspiratory pressure., therefore (consequently), expiration commences with a higher pressure difference.'}, {'measure': 'Expiration time would be shortened, resulting in a potentially higher flow rate', 'timeFrame': 'during surgery', 'description': 'We assumed (hypothesized) that the expiration time would be shortened, resulting in a potentially higher flow rate compared to pre-pneumoperitoneum conditions. Additionally, we also conducted calculations to establish correlations between respiratory parameters and the mean increment in expiratory flow rate relative to the baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical ventilation; body mass index; chest compliance; pneumoperitoneum; expiratory flow rate, intraabdominal pressure, laparoscopic surgery'], 'conditions': ['Pneumoperitoneum Increases Mean Expiratory Flow Rate']}, 'descriptionModule': {'briefSummary': 'Upon introducing pneumoperitoneum our research team noticed a reduction in expiration time displayed on the screen of the anesthesia machine. Since most respirators do not directly indicate the length of expiratory time and the average expiratory flow rate, we decided to investigate whether pneumoperitoneum really accelerates expiratory flow rate and thus shortens expiratory time.', 'detailedDescription': 'Furthermore we also intended to investigate which ventilation parameters these changes can be correlated with, elucidating the factors contributing to the acceleration of expiration..\n\nThis study aims to uncover the physiological mechanisms behind alterations in respiratory dynamics during and after pneumoperitoneum, offering valuable insights that may aid in refining ventilation strategies in the context of laparoscopic procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Helthy lung patients, over age 18 years, males and femailes together.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective laparoscopic abdominal surgery, healthy lung patients, age over 18 years. Obrained, written informed consent to partake in the research.\n\nExclusion Criteria:\n\nchronic obstructive pulmonary disease, bronchial asthma, silicosis, and those with a history of previous lung surgery, patients under 18 years of age, those who had not provided consent, and pregnant individuals were excluded from the study.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06212258', 'briefTitle': 'Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients', 'orgStudyIdInfo': {'id': '9746 - PTE - 2023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Abdominal Laparascopy', 'type': 'PROCEDURE', 'description': 'pneumoperitoneum'}]}, 'contactsLocationsModule': {'locations': [{'zip': '7623', 'city': 'Pécs', 'state': 'Baranya', 'country': 'Hungary', 'facility': 'Department of Anaesthesia and Intensive Care, Medical School, University of Pécs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balázs Sütő', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant Anaesthetist', 'investigatorFullName': 'Balázs Sütő', 'investigatorAffiliation': 'University of Pecs'}}}}