Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-01 @ 6:31 PM
Study NCT ID:
NCT01826968
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2013-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D006935', 'term': 'Hypercapnia'}, {'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2013-03-29', 'studyFirstSubmitQcDate': '2013-04-04', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Compliance change measured as volume difference/pressure difference (dv/dp) or ml/cmH2O is being assessed', 'timeFrame': 'Before recruitment, 3 minutes after recruitment, 10 minutes after recruitment and 20 minutes after recruitment'}], 'secondaryOutcomes': [{'measure': 'Oxygenation change is being assessed measured as PO2 (mmHg) and O2 Saturation (SPO2)', 'timeFrame': 'Before recruitment and 20 minutes after recruitment'}, {'measure': 'Gas exchange change is being assessed measured as PCO2 (mmHg) and PH.', 'timeFrame': 'Before recruitment and at 20 minutes after recruitment'}, {'measure': 'Pulmonary complications', 'timeFrame': 'up to 72 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung recruitment, cesarean, lung compliance, atelectasis'], 'conditions': ['Decreased Lung Compliance', 'Hypoxia', 'Hypercapnia', 'Atelectasis', 'Pneumonia']}, 'referencesModule': {'references': [{'pmid': '20608559', 'type': 'BACKGROUND', 'citation': 'Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.'}, {'pmid': '19443420', 'type': 'BACKGROUND', 'citation': 'Strang CM, Hachenberg T, Freden F, Hedenstierna G. Development of atelectasis and arterial to end-tidal PCO2-difference in a porcine model of pneumoperitoneum. Br J Anaesth. 2009 Aug;103(2):298-303. doi: 10.1093/bja/aep102. Epub 2009 May 13.'}, {'pmid': '16132894', 'type': 'BACKGROUND', 'citation': 'Hedenstierna G, Edmark L. The effects of anesthesia and muscle paralysis on the respiratory system. Intensive Care Med. 2005 Oct;31(10):1327-35. doi: 10.1007/s00134-005-2761-7. Epub 2005 Aug 16.'}, {'pmid': '23196259', 'type': 'BACKGROUND', 'citation': 'Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.'}]}, 'descriptionModule': {'briefSummary': 'The investigators tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. The investigators applied recruitment maneuver and positive end expiratory pressure (PEEP) 8 cmH2O. The maximum alveolar pressure limit (Ppeak)was 45 cmH2O during the recruitment maneuver. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O', 'detailedDescription': 'The investigators used recruitment maneuver during cesarean section and in women under general anesthesia. The primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmH2O after the recruitment maneuver. The investigators used 2 groups of patients. In the first group the investigators used pressure control ventilation for the recruitment maneuver. After the ventilator was switched to pressure control mode the investigators increased the inspiratory time to 50% and the inspiratory pressure above Positive End Expiratory Pressure (Ppeak) to 20 cmH2O. Then the investigators progressively increased Positive End Expiratory Pressure (PEEP) to have a peak inspiratory pressure (Ppeak) to 45 cm H2O. The whole recruitment maneuver lasts 2 minutes. After the recruitment maneuver the investigators used volume control ventilation again (with the baseline settings)and PEEP step wised decreased to 8 cmH20but. PEEP (8cmH2O) was left until the end of the operation. In the second group the investigators did not used lung recruitment maneuver at all. In both groups lung compliance was measured (dynamic and static)as dv/dp (ml/cmH2O). Measures were assessed 1 minute after delivery (but before recruitment), 3 minutes after recruitment (first group) at 10 and at 20 minutes after recruitment. The investigators also measured Ppeak (cmH2O) and Pplateau (cmH2O)inspiratory pressures , blood pressure (mmHG), beats per minute, oxygen saturation, end-tidal CO2 according to the above time frame, blood Gases before and 3 minutes after recruitment etc.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* general anesthesia,\n* hemodynamically stable\n\nExclusion Criteria:\n\n* intracranial hypertension,\n* pulmonary hypertension,\n* low blood pressure (MBP\\<80 mmHg),\n* Heart rate \\> 100 beats/min,\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT01826968', 'acronym': 'CSRecGHPyr', 'briefTitle': 'Alveolar Recruitment Maneuver During Cesarean Section Improves Lung Compliance', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital Of Pyrgos'}, 'officialTitle': 'Phase 2 Study of the Alveolar Recruitment Maneuver in Cesarean Section', 'orgStudyIdInfo': {'id': 'Lung Recruitment in Cesareans'}, 'secondaryIdInfos': [{'id': 'GHPyrgosRECProt', 'type': 'OTHER', 'domain': 'RECProt010113'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recruitment Group', 'description': 'The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. In this group PEEP was set to 8 cmH2O, after the recruitment maneuver, and was left until the end of the operation.', 'interventionNames': ['Procedure: Alveolar Recruitment maneuver']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'We did not used alveolar recruitment maneuver'}], 'interventions': [{'name': 'Alveolar Recruitment maneuver', 'type': 'PROCEDURE', 'description': 'In this group and during recruitment maneuver the investigators used pressure control ventilation and increased inspiratory time to 50%. The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. After the maneuver PEEP was set to 8 cmH2O and was left until the end of the operation. After the end of the recruitment maneuver volume control ventilation was used until the end of the operation too.', 'armGroupLabels': ['Recruitment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pýrgos', 'state': 'Hlia', 'country': 'Greece', 'facility': 'General Hospital of Pyrgos', 'geoPoint': {'lat': 37.67513, 'lon': 21.44102}}], 'overallOfficials': [{'name': 'Diamanto Aretha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Pyrgos, Sintriada, Pyrgos, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital Of Pyrgos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology Consultant Grade A, MD, Ph.D', 'investigatorFullName': 'Diamanto Aretha', 'investigatorAffiliation': 'General Hospital Of Pyrgos'}}}}