Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-05 @ 5:41 PM
Study NCT ID:
NCT00507533
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2007-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Application of CPAP in Hematologic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2007-07-25', 'studyFirstSubmitQcDate': '2007-07-25', 'lastUpdatePostDateStruct': {'date': '2009-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mechanical ventilation and intubation'}], 'secondaryOutcomes': [{'measure': 'Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CPAP', 'Hematologic', 'Neutropenic', 'ARF'], 'conditions': ['Hematologic Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the use of CPAP in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied preventively in hematological patients with high risk of ARF may reduce:need for intubations and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and hospital stay', 'detailedDescription': 'Immunocompromised patients with a hematological malignancy that requiring admission in intensive care unit (ICU) and subsequently mechanical ventilation for respiratory failure was estimated between 20- 50 per cent of all admitted in hospital.\n\nThe survival rate of this patients that requiring mechanical ventilation is very poor.\n\nIn many cases the immunodepression with a great improvement in severe complication as infections , pneumonia, sepsis , is the consequence of our therapy ( chemotherapy , bone marrow transplantation and stem cell transplantation ) .\n\nPneumonia is very common cause of mechanical ventilation in about 45-74 per cent of the all patient with acute respiratory failure (ARF) .\n\nThe trial was designed to enroll 40 patients in two groups to demonstrate reduction from 50% to 10 % of the need of mechanical ventilation , with a type I risk of error of 5% and a power of 80 %.\n\nPatients were randomized to be treated for four days Venturi mask at a FiO2 of 0.4 (control) or with oxygen at a FiO2 of 0.4 plus a CPAP of 10 cm H2O (CPAP). At the end of the 4-days period, patients passed a screening test breathing ambient air. Patients returned to the assigned treatment if SaO2 less than 95% a.a or respiratory rate more than 25 bpm.CPAP was generated using a flow generator with an adjustable inspiratory oxygen fraction set to deliver a flow of up to 140 liters per minute (Whisperflow, Caradyne, Ireland) and a spring-loaded expiratory pressure valve (Vital Signs Inc, Totoma NJ) and applied using a latex-free polyvinyl chloride transparent helmet (CaStar, Starmed, Italy) (15); all centers measured the inspiratory oxygen fraction using an oxygen analyzer (Oxicheck, Caradyne, Ireland) through the Venturi mask or the helmet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neutropenic hematological patients ( less than 1000 leukocytes /mm3 ) .\n* SaO2 less than 95% ( a.a.) ,\n* Respiratory rate (RR ) more than 25 breaths/minute .\n\nExclusion Criteria:\n\n* NYHA class II- III- IV or unstable angina or MI\n* Valvular heart disease or cardiac surgery ( previous 3 months)\n* Implanted cardiac pacemaker\n* BMI less than 40\n* History of dilated cardiomyopathy or CPE\n* Severe COPD ( oxygen therapy , recent exacerbation, hypoxemic-hypercapnic to resting , FEV1 \\< 50 %)\n* Diagnosis of sleep or neuromuscular disorders.\n* Claustrophobia .\n* Mechanical ventilation criteria:\n\n * Severe hypoxemia (arterial oxygen saturation \\< 80 % with maximal FiO2 )\n * Ph \\< 7.3 with a PaCO2 \\> 50 mmHg\n * Signs of patient distress with accessory muscle recruitment and paradoxal abdomen movement\n * RR \\> 35 breaths/minute .'}, 'identificationModule': {'nctId': 'NCT00507533', 'acronym': 'HEMOCPAP', 'briefTitle': 'Early Application of CPAP in Hematologic', 'organization': {'class': 'OTHER', 'fullName': 'University of Turin, Italy'}, 'officialTitle': 'Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure', 'orgStudyIdInfo': {'id': 'CPAP-2-H'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continuous positive airway pressure', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10100', 'city': 'Turin', 'state': 'Piedmont', 'country': 'Italy', 'facility': 'Università degli Studi Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Squadrone Vincenzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turin, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera San Giovanni Battista', 'class': 'OTHER'}]}}}