Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-28 @ 1:40 AM
Study NCT ID:
NCT05698004
Status:
UNKNOWN
Last Update Posted:
2023-01-26
First Post:
2022-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with acute hypoxemic respiratory failure attending the participating centres will receive either prone positioning + standard treatment or standard treatment only. All new acute hypoxemic respiratory failure patients will receive prone positioning + standard treatment for the first two weeks of the study. During the following two weeks, all new patients will receive standard treatment only. These cycles will be repeated until completion the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 244}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-15', 'studyFirstSubmitDate': '2022-12-30', 'studyFirstSubmitQcDate': '2023-01-15', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants within intervention arm whom need endotracheal intubation.', 'timeFrame': '30 days of randomization.', 'description': 'Intubation is needed when one major criterion including (cardiac or respiratory arrest; hemodynamic instability, life threatening arrhythmias, inability to protect the airway; coma or psychomotor agitation and intolerance to NIV interface; and two of the following minor criteria: RR\\> 35/min., PaO2/FiO2\\<200 mmHg, and respiratory acidosis (pH\\<7.30)).'}], 'secondaryOutcomes': [{'measure': 'Number of days on a ventilator.', 'timeFrame': '30 days of randomization.', 'description': 'weaning considered successful if patient is able to achieve the following within 48 hours: pH \\>7.35, Decrease in PaCO2 of \\>15-20%, PaO2\\>60 mmHg, SaO2\\> 90% on FiO2 \\<40%, Respiratory rate \\< 24 bpm and No signs of respiratory distress like agitation, diaphoresis or anxiety.'}, {'measure': 'mortality.', 'timeFrame': '60 days of randomization.'}, {'measure': 'Length of ICU stay in days.', 'timeFrame': '60 days of randomization.', 'description': 'duration of ICU stay from time of admission till discharge from ICU in days.'}, {'measure': 'Length of hospital stay in days.', 'timeFrame': '60 days of randomization.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure, ICU']}, 'referencesModule': {'references': [{'pmid': '26903337', 'type': 'BACKGROUND', 'citation': 'Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.'}, {'pmid': '30872586', 'type': 'BACKGROUND', 'citation': 'Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.'}, {'pmid': '24134414', 'type': 'BACKGROUND', 'citation': 'Gattinoni L, Taccone P, Carlesso E, Marini JJ. Prone position in acute respiratory distress syndrome. Rationale, indications, and limits. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1286-93. doi: 10.1164/rccm.201308-1532CI.'}]}, 'descriptionModule': {'briefSummary': 'Patients admitted to the ICU with severe hypoxemia are at high risk for mortality. Few therapies have been proven to improve patient outcomes or duration of mechanical ventilation e.g. low tidal volume ventilation, prone positioning, and a fluid-restrictive strategy. Prone positioning is a technique used to help patients with acute respiratory distress syndrome breathe better. There is high degree of uncertainty on its effects on clinical outcomes in non-intubated patients with acute hypoxemia and larger studies are needed.', 'detailedDescription': 'we plan to study the effect of prone positioning versus standard treatment in non-intubated patients with acute hypoxemia admitted at Respiratory Intensive Care Unit (RICU), Chest Department, Assiut University Hospital, Egypt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 years or older who are not intubated and required at least 40% oxygen (via low- or high-flow oxygen devices) or noninvasive positive pressure ventilation.\n\nExclusion Criteria: Patients will be excluded from the study if they :\n\nhad received invasive mechanical ventilation, had contraindications to prone positioning, are at risk of complications from prone positioning, had been self-prone positioning prior to enrollment and Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05698004', 'briefTitle': 'A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'A Wake Prone Positioning in Non-intubated Patients With Acute Hypoxemic Respiratory Failure', 'orgStudyIdInfo': {'id': 'prone positioning in ICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group-1: prone positioning + standard treatment', 'description': 'Patients randomized to the intervention group will be subjected to awake prone positioning. The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU. The treating team will supervise patients who could move themselves during the prone positioning process and assist the patients with positioning as required.', 'interventionNames': ['Other: prone positioning']}, {'type': 'NO_INTERVENTION', 'label': 'Group-2: Standard treatment only', 'description': 'Patients randomized to the control group, and their treating team, will be informed of their group assignment. Nurses instruct patients not to position themselves in the prone position.'}], 'interventions': [{'name': 'prone positioning', 'type': 'OTHER', 'description': 'The target duration of prone positioning is 8 h/d to 10 h/d with 2 to 3 breaks (1-2 hours each), if needed. Daily prone positioning sessions will be protocolized to continue until 1 of the following stopping criteria is met: a relative improvement in the FIO2 requirement by 40% from the baseline value that sustained for 24 hours; endotracheal intubation; or discharge from the ICU.', 'armGroupLabels': ['Group-1: prone positioning + standard treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Montaser Gamal', 'role': 'CONTACT', 'email': 'montaser_zahran@yahoo.com', 'phone': '01008951058'}, {'name': 'Aliae AR Mohamed Hussein', 'role': 'CONTACT', 'email': 'aliaehussein@gamil.com'}], 'overallOfficials': [{'name': 'Sahar Refaat Mahmoud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit university hospital'}, {'name': 'Sarah Mohamed Hashem Hamza.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit university hospital'}, {'name': 'Emad Zareef', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montaser Gamal Ahmed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Montaser Gamal Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}