Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 5:10 PM
Study NCT ID:
NCT06901050
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2025-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of FAST HUGS WITH ICU Approach on Length of Intensive Care Unit Stay in Patients With Hypoxic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-23', 'studyFirstSubmitDate': '2025-03-23', 'studyFirstSubmitQcDate': '2025-03-23', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': '1 month', 'description': "The difference between the duration of participants' admission to the intensive care unit and the time they are discharged from the intensive care unit will be examined."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypoxic respiratory failure'], 'conditions': ['Hypoxic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'This study will investigate the effect of the FAST HUGS WITH ICU approach on the length of stay in the intensive care unit in patients with hypoxic respiratory failure. Patients will be randomly assigned to the experimental and control groups. The standard procedure will be applied to the control group. The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist). The two groups will be examined in terms of hospital stay and some blood gas parameters.', 'detailedDescription': 'Hypoxic respiratory failure is responsible for 1.9 million patient admissions per year in the United States alone, and the hospital mortality rate is as high as 20%. This rate is also increasing in Turkey. The most common causes include pneumonia, cardiogenic pulmonary edema, ARDS, and chronic obstructive pulmonary disease (COPD). Fast hugs is important in affecting the prognosis of patients with hypoxic respiratory failure in special clinics such as the Chest Diseases Intensive Care Unit. Therefore, new studies are needed. This study will investigate the effect of the FAST HUGS WITH ICU approach on the length of stay in the intensive care unit in patients with hypoxic respiratory failure. Patients will be randomly assigned to the experimental and control groups. The standard procedure will be applied to the control group. The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist). The two groups will be examined in terms of hospital stay and some blood gas parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old\n* Being in the Chest Intensive Care Unit\n* Having Hypoxic Respiratory Failure\n\nExclusion Criteria:\n\n* Death during hospitalization'}, 'identificationModule': {'nctId': 'NCT06901050', 'briefTitle': 'Effect of FAST HUGS WITH ICU Approach on Length of Intensive Care Unit Stay in Patients With Hypoxic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Muş Alparslan University'}, 'officialTitle': 'Effect of FAST HUGS WITH ICU Approach on Length of Intensive Care Unit Stay in Patients With Hypoxic Respiratory Failure: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MuşAlparslan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'The FAST HUGS WITH ICU approach will be applied to the experimental group. We plan to follow up patients with Hypoxic Respiratory Failure using the abbreviation FAST HUGS WITH ICU (Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist).', 'interventionNames': ['Other: FAST HUGS WITH ICU approach']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'The standard procedure will be applied to the control group.'}], 'interventions': [{'name': 'FAST HUGS WITH ICU approach', 'type': 'OTHER', 'description': 'FAST HUGS WITH ICU; It is an abbreviation of "Feeding, Analgesia, Sedation, Thromboembolic prophylaxis, Head of bed elevation, Stress Ulcer prophylaxis and Glucose control Spontaneous breathing trial, Water Balance and constipation, Investigation and results, Therapy, Hypo-hyper delirium, Invasive devices, Check the daily infection parameters, Use a checlist". With this approach, patients will be followed up.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25040', 'city': 'Erzurum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Eda Ay, Dr', 'role': 'CONTACT', 'email': 'memnuniyet@atauni.edu.tr', 'phone': '0442 344 6666'}, {'name': 'Gamze KOÇ, Specialist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Burak YAVUZ, Specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bahar ÇİFTÇİ, Associate Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hanım Duru YÜCE BAŞARAN, Specialist', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dilara KOÇYİĞİT, Specialist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ataturk University Research Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Eda Ay, Dr.', 'role': 'CONTACT', 'email': 'memnuniyet@atauni.edu.tr', 'phone': '(0442) 344 66 66'}], 'overallOfficials': [{'name': 'Güzel Nur YILDIZ, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Muş Alparslan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muş Alparslan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}