Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-25 @ 8:20 PM
Study NCT ID:
NCT02714556
Status:
WITHDRAWN
Last Update Posted:
2016-11-01
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Ethical approval not obtained yet as questioning the danger of providing 100% oxygen to parturients.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-30', 'studyFirstSubmitDate': '2016-03-01', 'studyFirstSubmitQcDate': '2016-03-15', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section', 'timeFrame': '1-3 days prior to caesarean section until 5 days postoperative', 'description': 'Nitrogen multiple breath washout technique'}], 'secondaryOutcomes': [{'measure': 'Alterations in FRC throughout the postpartum period', 'timeFrame': '1-3 days prior to caesarean section until 5 days postoperative', 'description': 'Nitrogen multiple breath washout technique'}, {'measure': 'Changes in respiratory mechanics: respiratory system compliance (Crs)', 'timeFrame': '1-3 days prior to caesarean section until 5 days postoperatively', 'description': 'Forced oscillation technique'}, {'measure': 'Changes in respiratory mechanics: airway resistance (Raw)', 'timeFrame': '1-3 days prior to caesarean section until 5 days postoperatively', 'description': 'Forced oscillation technique'}, {'measure': 'Perioperative respiratory complications', 'timeFrame': 'During caesarean section until 5 days postoperatively', 'description': 'Apnoea/bradypnoea, oxygen desaturation \\<90%/hypoxemia, hypoventilation/atelectasis, pulmonary embolism, incoercible cough'}, {'measure': 'Perioperative respiratory interventions', 'timeFrame': 'During caesarean section until 5 days postoperatively', 'description': 'Intubation, oxygen therapy, bronchodilator, adrenaline, continuous positive airways pressure (CPAP), respiratory physiotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung volume', 'Lung Clearance Index', 'Functional Residual Capacity', 'Respiratory function'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of this prospective observational study is to examine the perioperative changes in ventilation inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath washout and forced oscillation techniques.', 'detailedDescription': 'Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. These alterations lead to a ventilation/perfusion mismatch which is potentiated by a decrease in functional residual capacity (FRC). These effects explain why pregnant women are more prone to the occurrence of hypoxemia, particularly in the third trimester of their pregnancy. The importance of the ventilation inhomogeneity can be estimated from the lung clearance index (LCI) measured by the non-invasive nitrogen multiple breath washout (N2 MBW) technique. Moreover the loss in lung volume is associated with reduction in respiratory system compliance, which can also be assessed non-invasively by the forced oscillation technique (FOT).\n\nTo our knowledge, there is no existing data on LCI or FRC using the aforementioned techniques in pregnant women. Furthermore, existing data on respiratory function in pregnant women is largely restricted to spirometric and body plethysmographic measurements taken primarily in the 1970s-1980s. As such, the important roles of lung ventilation inhomogeneity as well as the potential changes following birth after caesarean section have yet to be completely characterised.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women scheduled for elective caesarean section in gestational weeks 37-40', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent\n* Pregnant woman in the third trimester (37-40 weeks gestational age)\n* Scheduled for elective caesarean section under regional (spinal or combined spinal-epidural) anaesthesia\n\nExclusion Criteria:\n\n* Pregnant women outside 37-40 weeks gestational age\n* Non-singleton pregnancy\n* Previous history of ≥2 caesarean sections\n* History or clinical signs of cardiopulmonary disease in the last 12 months (chronic hypertension, gestational hypertension, preeclampsia, asthma, acute or chronic bronchitis, others)\n* Positive current smoking status\n* Pre-pregnant body mass index (BMI) \\>30 kg/m2 (based on booking records)\n* Respiratory infection \\<2 weeks prior to surgery\n* Inability to perform the respiratory function tests'}, 'identificationModule': {'nctId': 'NCT02714556', 'acronym': 'VIRCA', 'briefTitle': 'Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'VIRCA-2016'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Physiologic measures of lung function', 'type': 'OTHER', 'description': 'Respiratory function tests:\n\nNitrogen multiple breath washout (N2MBW) measured with an ultrasonic flowmeter (Exhalyzer D with ICU insert, Eco Medics, Duernten, Switzerland) Forced oscillation technique (FOT) measured with a tremoFlo device (Thorasys, Montreal, Canada)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1206', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'University Hospitals of Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Walid Habre, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Geneva'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walid HABRE', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Walid HABRE', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}