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| Name | Class |
|---|---|
| Advanced Cooling Therapy, Inc., d/b/a Attune Medical | INDUSTRY |
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The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival.
This is a small scale pilot study to evaluate if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. This prospective, randomized study will include 20 patients diagnosed with COVID-19, and undergoing mechanical ventilation for the treatment of respiratory failure. Patients will be randomized in a 1:1 fashion with 10 patients (Group A) randomized to undergo core warming, and the other 10 patients (Group B) serving as the control group who will not have the ensoETM device used. Patients randomized to Group A will have core warming initiated in the ICU or other clinical environment in which they are being treated after enrollment and provision of informed consent from appropriate surrogate or legally authorized representative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core warming | Experimental | Patients receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming |
|
| Standard of Care | Active Comparator | Patients receive standard temperature management and treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core Warming | Device | Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PaO2/FiO2 Ratio | Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care. | 0, 24, 48, and 72 hours after initiation of core warming |
| Measure | Description | Time Frame |
|---|---|---|
| Cycle Threshold at 72-hours | Determine the change cycle threshold after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care. | 72 hours after initiation of core warming |
| Ventilator-Free Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Willms, MD | Sharp HealthCare | Principal Investigator |
| Ahmed Salem, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31058720 | Background | Evans EM, Doctor RJ, Gage BF, Hotchkiss RS, Fuller BM, Drewry AM. The Association of Fever and Antipyretic Medication With Outcomes in Mechanically Ventilated Patients: A Cohort Study. Shock. 2019 Aug;52(2):152-159. doi: 10.1097/SHK.0000000000001368. | |
| 29240644 | Background | Drewry AM, Ablordeppey EA, Murray ET, Dalton CM, Fuller BM, Kollef MH, Hotchkiss RS. Monocyte Function and Clinical Outcomes in Febrile and Afebrile Patients With Severe Sepsis. Shock. 2018 Oct;50(4):381-387. doi: 10.1097/SHK.0000000000001083. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Core Warming | Patients assigned to receive the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. |
| FG001 | Standard of Care | Patients assigned to receive standard temperature management and treatment Standard of Care: Standard temperature management and treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who were randomized and received either core warming treatment or standard of care treatment. Does not include patients were randomized and withdrawn from study prior to receiving treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Core Warming | Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PaO2/FiO2 Ratio | Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care. | Posted | Mean | Standard Error | Ratio | 0, 24, 48, and 72 hours after initiation of core warming |
|
Until 30 days post randomization or until hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Core Warming | Patients who received the Attune Medical Esophageal Heat Transfer Device (EnsoETM) and undergo core warming Core Warming: Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MSSA Bacteremia | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erik Kulstad, MD | Attune Medical | +1-708-651-0736 | ekulstad@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 | Jan 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Other | Standard temperature management and treatment |
|
Measure the impact of core warming on duration of mechanical ventilation. |
| Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation |
| 30-Day Mortality | Determine impact of core warming on patient mortality. | 30 days after initiation of core warming |
| 28221185 | Background | Drewry AM, Ablordeppey EA, Murray ET, Stoll CRT, Izadi SR, Dalton CM, Hardi AC, Fowler SA, Fuller BM, Colditz GA. Antipyretic Therapy in Critically Ill Septic Patients: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 May;45(5):806-813. doi: 10.1097/CCM.0000000000002285. |
| 25793436 | Background | Drewry AM, Fuller BM, Skrupky LP, Hotchkiss RS. The presence of hypothermia within 24 hours of sepsis diagnosis predicts persistent lymphopenia. Crit Care Med. 2015 Jun;43(6):1165-9. doi: 10.1097/CCM.0000000000000940. |
| 24028682 | Background | Drewry AM, Fuller BM, Bailey TC, Hotchkiss RS. Body temperature patterns as a predictor of hospital-acquired sepsis in afebrile adult intensive care unit patients: a case-control study. Crit Care. 2013 Sep 12;17(5):R200. doi: 10.1186/cc12894. |
| 32709253 | Background | Drewry AM, Hotchkiss R, Kulstad E. Response to "Body temperature correlates with mortality in COVID-19 patients". Crit Care. 2020 Jul 24;24(1):460. doi: 10.1186/s13054-020-03186-w. No abstract available. |
| 37527424 | Derived | Bonfanti NP, Mohr NM, Willms DC, Bedimo RJ, Gundert E, Goff KL, Kulstad EB, Drewry AM. Core Warming of Coronavirus Disease 2019 Patients Undergoing Mechanical Ventilation: A Pilot Study. Ther Hypothermia Temp Manag. 2023 Dec;13(4):225-229. doi: 10.1089/ther.2023.0030. Epub 2023 Aug 2. |
| Standard of Care |
Patients who received standard temperature management and treatment Standard of Care: Standard temperature management and treatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time to Enrollment | Mean | Standard Deviation | days |
|
| Height | Mean | Standard Deviation | meters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Tobacco Usage | Count of Participants | Participants |
|
| Ethanol Usage | Count of Participants | Participants |
|
| Pre-Existing Cardiovascular Condition | Count of Participants | Participants |
|
| Pre-Existing Respiratory Condition at Baseline | Count of Participants | Participants |
|
| Pre-Existing Hepatic Condition | Count of Participants | Participants |
|
| Pre-Existing Gastrointestinal Condition | Count of Participants | Participants |
|
| Pre-Existing Genitourinary Condition at Baseline | Count of Participants | Participants |
|
| Pre-Existing Endocrine Condition | Count of Participants | Participants |
|
| Pre-Existing Hematologic Condition | Count of Participants | Participants |
|
| Pre-Existing Musculoskeletal Condition | Count of Participants | Participants |
|
| Pre-Existing Neoplastic Condition | Count of Participants | Participants |
|
| Pre-Existing Neurologic Condition | Count of Participants | Participants |
|
| Pre-Existing Psychiatric Condition | Count of Participants | Participants |
|
| Pre-Existing Immunologic Condition | Count of Participants | Participants |
|
| Pre-Existing Dermatologic Condition | Count of Participants | Participants |
|
| Pre-Existing HEENT Condition | Count of Participants | Participants |
|
| Other Pre-Existing Condition | Count of Participants | Participants |
|
| Allergies | Count of Participants | Participants |
|
| Baseline Cycle Threshold | Mean | Standard Deviation | Cycles |
|
|
|
| Secondary | Cycle Threshold at 72-hours | Determine the change cycle threshold after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care. | Posted | Mean | Standard Deviation | Cycles | 72 hours after initiation of core warming |
|
|
|
| Secondary | Ventilator-Free Days | Measure the impact of core warming on duration of mechanical ventilation. | Posted | Mean | Standard Deviation | days | Initiation of Core Warming Until Patient Weaned Off Mechanical Ventilation |
|
|
|
| Secondary | 30-Day Mortality | Determine impact of core warming on patient mortality. | Posted | Count of Participants | Participants | 30 days after initiation of core warming |
|
|
|
| 2 |
| 9 |
| 1 |
| 9 |
| 9 |
| 9 |
| EG001 | Standard of Care | Patients who received standard temperature management and treatment Standard of Care: Standard temperature management and treatment | 4 | 10 | 2 | 10 | 9 | 10 |
| Stenotrophomonas maltophilia pneumonia and bacteremia | Infections and infestations | Systematic Assessment |
|
| Worsening of bilateral upper/lower extremity weakness | Nervous system disorders | Systematic Assessment |
|
| Diabetes mellitus | Endocrine disorders | Systematic Assessment |
|
| tachycardia | Cardiac disorders | Systematic Assessment |
|
| fungal infection | Infections and infestations | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| elevated D-dimer | Immune system disorders | Systematic Assessment |
|
| delirium | Nervous system disorders | Systematic Assessment |
|
| hypertension | Cardiac disorders | Systematic Assessment |
|
| hypertriglyceridemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| elevated liver function tests | Hepatobiliary disorders | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| adrenal insufficiency | Renal and urinary disorders | Systematic Assessment |
|
| E. coli pneumonia | Infections and infestations | Systematic Assessment |
|
| hypotension | Cardiac disorders | Systematic Assessment |
|
| pseudomonas aeruginosa pneumonia | Infections and infestations | Systematic Assessment |
|
| tracheobronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| E. coli bacteremia | Infections and infestations | Systematic Assessment |
|
| hypernatremia | Metabolism and nutrition disorders | Systematic Assessment |
|
| premature atrial contractions | Cardiac disorders | Systematic Assessment |
|
| hepatic steatosis | Hepatobiliary disorders | Systematic Assessment |
|
| penile skin yeast infection | Infections and infestations | Systematic Assessment |
|
| elevated procalcitonin | Immune system disorders | Systematic Assessment |
|
| PTH intact | Endocrine disorders | Systematic Assessment |
|
| septic shock | Infections and infestations | Systematic Assessment |
|
| supraglottic edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| dysphagia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| stammering | Nervous system disorders | Systematic Assessment |
|
| stool positive for occult blood | Gastrointestinal disorders | Systematic Assessment |
|
| toxic vacuoles | Immune system disorders | Systematic Assessment |
|
| elevated troponin | Cardiac disorders | Systematic Assessment |
|
| elevated eosinophils | Blood and lymphatic system disorders | Systematic Assessment |
|
| leukocytosis | Immune system disorders | Systematic Assessment |
|
| bacterial superinfection | Infections and infestations | Systematic Assessment |
|
| azotemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| mild respiratory alkalosis | Metabolism and nutrition disorders | Systematic Assessment |
|
| heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| possible herpes stomatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| hyperammonia cholestasis | Hepatobiliary disorders | Systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| toxic metabolic encephalopathy | Metabolism and nutrition disorders | Systematic Assessment |
|
| ileus | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| low phosphorous level | Metabolism and nutrition disorders | Systematic Assessment |
|
| femoral DVT | Vascular disorders | Systematic Assessment |
|
| Klebsiella pneumonia | Infections and infestations | Systematic Assessment |
|
| aortic valve stenosis | Cardiac disorders | Systematic Assessment |
|
| head tremor | Nervous system disorders | Systematic Assessment |
|
| pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| tracheostomy leak | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| tracheostomy wound infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| tracheobronchomalacia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| elevated PTT | Blood and lymphatic system disorders | Systematic Assessment |
|
| mastoiditis | Infections and infestations | Systematic Assessment |
|
| hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| elevated BUN | Metabolism and nutrition disorders | Systematic Assessment |
|
| tinea corpus under pannus | Infections and infestations | Systematic Assessment |
|
| anasarca | Vascular disorders | Systematic Assessment |
|
| epistaxis | Blood and lymphatic system disorders | Systematic Assessment |
|
| acute encephalopathy | Nervous system disorders | Systematic Assessment |
|
| elevated CA-125 tumor marker | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| elevated carcino-embyonic antigen | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| sepsis | Infections and infestations | Systematic Assessment |
|
| acute tubular necrosis | Renal and urinary disorders | Systematic Assessment |
|
| duodenal ulcers | Gastrointestinal disorders | Systematic Assessment |
|
| tongue deviation | Nervous system disorders | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| enterobacter penumonia | Infections and infestations | Systematic Assessment |
|
| elevated RDW | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |