Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-27 @ 11:35 AM
Study NCT ID:
NCT05996068
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-13
First Post:
2023-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial Line in Trauma Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062666', 'term': 'Vascular Access Devices'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'We use se before-after study type and only the after phase receive intervention. Before phase will retrospectively collect data from patient without arterial line intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-10', 'studyFirstSubmitDate': '2023-08-03', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite primary endpoint (including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index )', 'timeFrame': 'during ER stay, up to 6 hours', 'description': 'including any hypotension, vasopressors usage, any cardiac arrest in ER, Shock index (HR/SBP)\\>1'}], 'secondaryOutcomes': [{'measure': 'prolong ICU admission', 'timeFrame': 'up to 7 days', 'description': 'define as \\> 6 days of admission'}, {'measure': '30 days mortality rate', 'timeFrame': 'mortality within 30 days of trauma event', 'description': 'mortality within 30 days of trauma event'}, {'measure': 'volume of fluid administration', 'timeFrame': 'during ER stay, up to 6 hours', 'description': 'any type of fluid administration'}, {'measure': 'Area under curve (AUC) difference under different time measuring frequency', 'timeFrame': '1/3/5/10 minutes', 'description': 'We will use continuous blood pressure data and apply different intervals (1, 3, 5, and 10 minutes) to create a plot, then smooth it to calculate the area under the curve (AUC).'}, {'measure': 'units of red blood cell transfusion', 'timeFrame': 'during ER stay, up to 6 hours', 'description': 'units of red blood cell transfusion'}, {'measure': 'arterial blood pressure trajectory', 'timeFrame': 'during ER stay, up to 6 hours', 'description': 'We will depict the arterial blood pressure trajectory for each patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['major trauma', 'arterial line', 'resuscitation'], 'conditions': ['Major Trauma']}, 'referencesModule': {'references': [{'pmid': '18212658', 'type': 'BACKGROUND', 'citation': 'Teixeira PG, Inaba K, Hadjizacharia P, Brown C, Salim A, Rhee P, Browder T, Noguchi TT, Demetriades D. Preventable or potentially preventable mortality at a mature trauma center. J Trauma. 2007 Dec;63(6):1338-46; discussion 1346-7. doi: 10.1097/TA.0b013e31815078ae.'}, {'pmid': '2927596', 'type': 'BACKGROUND', 'citation': 'Klauber MR, Marshall LF, Luerssen TG, Frankowski R, Tabaddor K, Eisenberg HM. Determinants of head injury mortality: importance of the low risk patient. Neurosurgery. 1989 Jan;24(1):31-6. doi: 10.1227/00006123-198901000-00005.'}, {'pmid': '2213158', 'type': 'BACKGROUND', 'citation': 'Eisenberg HM, Gary HE Jr, Aldrich EF, Saydjari C, Turner B, Foulkes MA, Jane JA, Marmarou A, Marshall LF, Young HF. Initial CT findings in 753 patients with severe head injury. A report from the NIH Traumatic Coma Data Bank. J Neurosurg. 1990 Nov;73(5):688-98. doi: 10.3171/jns.1990.73.5.0688.'}, {'pmid': '17426904', 'type': 'BACKGROUND', 'citation': 'Tieu BH, Holcomb JB, Schreiber MA. Coagulopathy: its pathophysiology and treatment in the injured patient. World J Surg. 2007 May;31(5):1055-64. doi: 10.1007/s00268-006-0653-9.'}, {'pmid': '25807399', 'type': 'BACKGROUND', 'citation': 'Schreiber MA, Meier EN, Tisherman SA, Kerby JD, Newgard CD, Brasel K, Egan D, Witham W, Williams C, Daya M, Beeson J, McCully BH, Wheeler S, Kannas D, May S, McKnight B, Hoyt DB; ROC Investigators. A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial. J Trauma Acute Care Surg. 2015 Apr;78(4):687-95; discussion 695-7. doi: 10.1097/TA.0000000000000600.'}, {'pmid': '35887844', 'type': 'BACKGROUND', 'citation': 'Wijnberge M, van der Ster B, Vlaar APJ, Hollmann MW, Geerts BF, Veelo DP. The Effect of Intermittent versus Continuous Non-Invasive Blood Pressure Monitoring on the Detection of Intraoperative Hypotension, a Sub-Study. J Clin Med. 2022 Jul 14;11(14):4083. doi: 10.3390/jcm11144083.'}]}, 'descriptionModule': {'briefSummary': "Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due to trauma from falls and traffic accident. Among trauma patients, the common cause of death is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). The current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. Patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring.\n\nWith continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. In some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown.\n\nThe main purpose of this study is to investigate the application of arterial line insertion in trauma patients. The study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Glasgow Coma Scale (GCS) 13 or less\n* SBP \\< 90 mmHg\n* Respiratory rate \\< 10 or \\> 29 breaths/min\n* Fall from height \\> 6 meters\n* High-Risk Auto Crash: Partial or complete ejection, intrusion \\> 30 cm any site, Need for extrication for entrapped patient, Death in passenger compartment\n* Rider separated from transport vehicle with significant impact\n* Penetrating injuries to head, neck, torso, and proximal extremities\n* Skull deformity, suspected skull fracture\n* Chest wall instability, deformity, or suspected flail chest\n* Suspected pelvic fracture\n* Suspected fracture of two or more proximal long bones\n* Amputation proximal to wrist or ankle\n* Active bleeding requiring a tourniquet or wound packing with continuous pressure\n* Burns in conjunction with trauma\n\nExclusion Criteria:\n\n* Pregnancy\n* Patient or family who are unable to obtain informed consent\n* Known coagulopathy that is inappropriate for arterial line insertion\n* Known peripheral arterial occlusion disease that is inappropriate for arterial line insertion\n* traumatic cardiac arrest'}, 'identificationModule': {'nctId': 'NCT05996068', 'acronym': 'ALTR', 'briefTitle': 'Arterial Line in Trauma Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Enhancing Trauma Resuscitation Through Arterial Line Integration: A Before-After Study', 'orgStudyIdInfo': {'id': '202210095DINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'trauma patients with arterial line insertion', 'description': 'the after phase, actively recruited patients who are eligible for arterial line insertion', 'interventionNames': ['Device: arterial line']}, {'type': 'NO_INTERVENTION', 'label': 'trauma patients without arterial line insertion', 'description': 'the before phase, retrospectively data collection from the past'}], 'interventions': [{'name': 'arterial line', 'type': 'DEVICE', 'description': 'insert arterial line for patients who meet major trauma criteria', 'armGroupLabels': ['trauma patients with arterial line insertion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Douliu', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Yunlin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}