Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-26 @ 1:46 PM
Study NCT ID:
NCT05483959
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIPAP in the Management of Acute Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Mechanically ventilated ARDS patients'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'BIPAP mode of ventilation applied to 20patients , SIMV PC mode applied to the other group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-29', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen saturation of the participants will be measured from the arterial blood gases taken from the patient and according to the range of oxygen saturation from 90 to 98% will be compared', 'timeFrame': 'Baseline', 'description': 'Base line oxygen saturation of BIPAP group and SIMV PC group patients will be taken from the arterial blood gases and recorded from the range of oxygen saturation from 90 to 98% and will be compared between both groups'}, {'measure': 'Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device', 'timeFrame': 'Base line', 'description': 'Blood pressure in mm Hg of BIPAP group and SIMV PC group will be measured by the sphygmomanometer device and will be compared between both groups according to the normal range of systolic blood pressure from 90mmHg to 130mmHg and diastolic blood pressure from the range of 60 mmHg to 90 mmHg'}, {'measure': 'Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and recorded', 'timeFrame': '24 hours after mechanical ventilation', 'description': 'Lung mechanics including the tidal volume by ml per kg ideal body weight of BIPAP and SIMV PC groups will be taken from the ventilators and compared between both groups according to the range of tidal volume from 4 to 8 ml per kg ideal body weight'}], 'secondaryOutcomes': [{'measure': 'Duration of mechanical ventilation of BIPAP group', 'timeFrame': '6 weeks', 'description': 'The duration of mechanical ventilation duration had been compared between both groups'}, {'measure': 'The duration of anesthesia in days', 'timeFrame': '2 weeks', 'description': 'The duration of anesthesia in days on BIPAP group willassessed between BIPAP group and SIMV PC group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BIPAP , ARDS'], 'conditions': ['Mechanical Ventilation Complication']}, 'referencesModule': {'references': [{'pmid': '22797452', 'type': 'BACKGROUND', 'citation': 'ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.'}, {'pmid': '12205405', 'type': 'BACKGROUND', 'citation': 'Hedenstierna G, Lattuada M. Gas exchange in the ventilated patient. Curr Opin Crit Care. 2002 Feb;8(1):39-44. doi: 10.1097/00075198-200202000-00007.'}, {'pmid': '8143712', 'type': 'RESULT', 'citation': 'Hormann C, Baum M, Putensen C, Mutz NJ, Benzer H. Biphasic positive airway pressure (BIPAP)--a new mode of ventilatory support. Eur J Anaesthesiol. 1994 Jan;11(1):37-42.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of biphasic positive airway pressure as a new mode of ventilation in management of acute respiratory failure constituted in ARDS as a category of hypoxaemic respiratory failure in comparison to conventional ventilation.', 'detailedDescription': "Biphasic positive airway pressure (BIPAP) is a mode of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. BIPAP mode is pressure-limited and time-cycled, Ventilation occurs via the time-cycled switching between two set pressure levels. In the absence of spontaneous breathing, this mode resemble conventional pressure controlled ventilation.\n\nA proposed advantage of BIPAP compared to conventional pressure-controlled ventilation is the improved distribution of gas to dependent lung regions as the result of spontaneous breathing enabled during the inspiratory and expiratory time cycles, so prevents atelectasis and promotes alveolar recruitment resulting in an improved ventilation-perfusion matching.\n\nARDS is an acute diffuse, inflammatory lung injury, leading to increased pulmonary vascular permeability, increased lung weight, and loss of aerated lung tissue with hypoxemia and bilateral radiographic opacities, associated with increased venous admixture, increased physiological dead space and decreased lung compliance.\n\nIn patients with ARDS, BIPAP with spontaneous breathing contributes to improved pulmonary gas exchange, systemic blood flow and oxygen supply to the tissue. This is reflected by clinical improvement in the patient's condition, which is associated with significantly fewer days on ventilatory support, earlier extubation and a shorter stay in the intensive care unit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All intubated Adult ARDS patients\n* ARDS is diagnosed according to berlin criteria.\n\nExclusion Criteria:\n\n* Age \\< 18 years.\n* Cardiac or respiratory arrest on admission.\n* Morbid obesity with BMI \\> 40.\n* Acute exacerbation of IPF.\n* Cerebrovascular or neuro muscular disorder. 6. Diabetic ketoacidosis. 7. Hepatic or renal disease. 8.Cardiac disease.'}, 'identificationModule': {'nctId': 'NCT05483959', 'briefTitle': 'BIPAP in the Management of Acute Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Biphasic Positive Airway Pressure in the Management of Acute Respiratory Distress Syndrome: A Comparative Study', 'orgStudyIdInfo': {'id': 'BIPAP IN ARDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIPAP group', 'description': 'Mechanically ventilated ARDS patients on BIPAP mode of ventilation', 'interventionNames': ['Other: BIPAP mode/SIMV PC mode']}, {'type': 'EXPERIMENTAL', 'label': 'SIMV PC group', 'description': 'Mechanically ventilated ARDS patients on SIMV PC mode of ventilation', 'interventionNames': ['Other: BIPAP mode/SIMV PC mode']}], 'interventions': [{'name': 'BIPAP mode/SIMV PC mode', 'type': 'OTHER', 'description': 'BIPAP is a mode of ventilation recently used in ARDS', 'armGroupLabels': ['BIPAP group', 'SIMV PC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1462506', 'city': 'Qina', 'state': 'Qena Governorate', 'country': 'Egypt', 'facility': 'Shymaa Sayed Salem', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'overallOfficials': [{'name': 'Khaled H Ahmed, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Alaa R Mahmoud, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine, South Valley University'}, {'name': 'Gad S Gad, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'faculty of medicine, South Valley University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Shymaa Sayed Salem', 'investigatorAffiliation': 'South Valley University'}}}}