Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-30 @ 6:46 PM
Study NCT ID:
NCT01354769
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2011-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Capnography Library - Data Collection in the Critical Care Environment Stage 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-24', 'studyFirstSubmitDate': '2011-05-16', 'studyFirstSubmitQcDate': '2011-05-16', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'Capgnography is the monitoring of the concentration or partial pressure of carbon dioxide in the expired respiratory gases; as such, it is a non-invasive monitoring technique which allows fast and reliable insight into ventilation, circulation and metabolism. Capnography has proven to be more effective than clinical judgement alone in the early detection of adverse respiratory events. The shape of a capnogram is identical in all humans with healthy lungs; any deviations in shape must be investigated to determine a physiological or a pathological cause of the abnormality.\n\nData from a previous pilot study yielded two major findings:\n\n1. Prediction of requirement for intubation, by the creation of an "Integrated Pulmonary Index" (IPI) based on non-invasive physiological parameters\n2. Breathing patterns during weaning in order to identify specific patterns used to predict extubation success/failure\n\nThe intent of the current study is to gather sufficient data to either prove or disprove the findings of the previous study', 'detailedDescription': "The patient's monitoring period will be as follows:\n\nNon-intubated patients - Initiation: As soon as possible after admission and/or extubation and no later than 24 hours after either. Termination- either 2 hours after intubation or after 8 hours of monitoring overall.\n\nIntubated patients - Initiation: No later than 24 hours after a decision to begin weaning has been made . Termination: Upon ICU (Intensive Care Unit) discharge or for the duration of 10 days at most.\n\nData will be collected using three tools:\n\n1. CapnoStream raw data (CO2 (Carbon dioxide) waveform, EtCO2 (End-tidal Carbon dioxide), respiratory rate, SpO2 (Saturation of peripheral Oxygen), pulse rate, IPI, alarms, events and any other messages generated by the monitor) will be transferred from the monitor to a laptop via a dedicated recording program.\n2. Ventilator data (settings and resultant patient parameters) will be transferred from the monitor to a laptop via a dedicated recording program.\n3. Patient monitoring parameters (heart rate, blood pressure, CVP (Central Venous Pressure), temperature, spirometry values etc) shall be recorded from the multi parameter monitors already in use in the ICU and transferred online to a laptop using dedicated recording software.\n\nAll recorded parameters will be synchronized. Data will be recorded from at least two of the tools, the Capnostream and the ventilator."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-intubated and intubated patients being treated for severe illnesses in the intensive care unit', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Over the age of 18\n* Suffering from severe illness requiring admission to the ICU\n* Expected to be hospitalized in the ICU for a minimum of 8 hours\n\nExclusion Criteria:\n\n* Under the age of 18\n* The patient's refusal to participate in the study\n* Any change in the patient's condition that may interfere with data collection"}, 'identificationModule': {'nctId': 'NCT01354769', 'briefTitle': 'Capnography Library - Data Collection in the Critical Care Environment Stage 2', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Capnography Library - Data Collection in the Critical Care Environment Stage 2', 'orgStudyIdInfo': {'id': 'D0006746A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-intubated patients', 'interventionNames': ['Device: CapnoStream20']}, {'label': 'Intubated patients', 'interventionNames': ['Device: CapnoStream20']}], 'interventions': [{'name': 'CapnoStream20', 'type': 'DEVICE', 'otherNames': ['Capnostream Bedside Monitor, Oridion Medical Ltd.'], 'description': 'The monitor used for data gathering is a CapnoStream20-multi parameter monitor', 'armGroupLabels': ['Intubated patients', 'Non-intubated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Sharon Einav-Bromiker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}