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The primary objective of this study is to evaluate the performance of the Acumenâ„¢ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
The primary objective of this study is to evaluate the performance of the Acumenâ„¢ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assisted Fluid Management | Experimental | Subjects enrolled in the validation study will have their fluid management decisions guided by the Acumenâ„¢ Assisted Fluid Management Feature. The Principal Investigator will accept or decline fluid recommendations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature | Device | Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the Assisted Fluid Management Feature | Stroke volume change meeting the clinician-selected fluid strategy | 30 Day follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tina Abdelnour, MS, BSN | Edwards Lifesciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda Health University | Loma Linda | California | 92354 | United States | ||
| University of California, Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18582931 | Background | Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Assisted Fluid Management | EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 25, 2018 | Jun 18, 2021 |
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| Sacramento |
| California |
| 95817 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Stony Brook Medicine | Stony Brook | New York | 11794-8480 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Greenville Health System, Greenville Memorial Hospital | Greenville | South Carolina | 29605 | United States |
| The University of Texas Southwestern at Clements | Dallas | Texas | 75390 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314.
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| ID | Title | Description |
|---|---|---|
| BG000 | Assisted Fluid Management | EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314. | Median | Inter-Quartile Range | years |
| ||||||||||||||
| Sex: Female, Male | Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Measure Analysis Population Description: Arterial Pressure Monitoring (enrolled) N=330. Two pilot subjects were permitted per site for training purposes N=16. Pivotal Cohort (Safety) N=314. | Count of Participants | 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 | Effectiveness of the Assisted Fluid Management Feature | Stroke volume change meeting the clinician-selected fluid strategy | Posted | Count of Participants | Participants | 30 Day follow-up |
|
|
|
9 Months
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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 | Assisted Fluid Management | EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature: Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature. | 0 | 314 | 88 | 314 | 226 | 314 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Complication associated with device | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Biliary colic | Hepatobiliary disorders | Systematic Assessment |
| ||
| Ischaemic hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal ischaemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intra-abdominal fluid collection | Gastrointestinal disorders | Systematic Assessment |
| ||
| Jejunal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Malaena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oedematous pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis necrotising | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peritoneal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abscess | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Device related sepsis | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Gangrene | Infections and infestations | Systematic Assessment |
| ||
| Graft infection | Infections and infestations | Systematic Assessment |
| ||
| Ophthalmic herpes simplex | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Pancreatic abscess | Infections and infestations | Systematic Assessment |
| ||
| Peritonitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Purulent discharge | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Scrotal infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cement embolism | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Confusion postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incarcerated incisional hernia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Peripancreatic fluid collection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stoma site discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stoma site ischaemia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood culture positive | Investigations | Systematic Assessment |
| ||
| Oxygen saturation decreased | Investigations | Systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Compartment syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hypotension | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Device occlusion | Product Issues | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Vesical fistula | Renal and urinary disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Abscess drainage | Surgical and medical procedures | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Distributive shock | Vascular disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Peripheral ischaemia | Vascular disorders | Systematic Assessment |
| ||
| Shock haemorrhagic | Vascular disorders | Systematic Assessment |
| ||
| Venous thrombosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Diplopia | Eye disorders | Systematic Assessment |
| ||
| Eye Swelling | Eye disorders | Systematic Assessment |
| ||
| Abdominal hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus paralytic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired gastric emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal ischaemia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Intra-abdominal fluid collection | Gastrointestinal disorders | Systematic Assessment |
| ||
| Jejunal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lower gastrointestinal perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Melaena | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Obstruction gastric | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oedematous pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis necrotising | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peritoneal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pneumatosis intestinalis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting projectile | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Catheter site ischaemia | General disorders | Systematic Assessment |
| ||
| Complication associated with device | General disorders | Systematic Assessment |
| ||
| Hypothermia | General disorders | Systematic Assessment |
| ||
| Infusion site extravasation | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Bile duct obstruction | Hepatobiliary disorders | Systematic Assessment |
| ||
| Bile duct stenosis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Biliary colic | Hepatobiliary disorders | Systematic Assessment |
| ||
| Ischaemic hepatitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Abscess | Infections and infestations | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Bacterial disease carrier | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis viral | Infections and infestations | Systematic Assessment |
| ||
| Tenderness | General disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Device related sepsis | Infections and infestations | Systematic Assessment |
| ||
| Diverticulitis | Infections and infestations | Systematic Assessment |
| ||
| Gangrene | Infections and infestations | Systematic Assessment |
| ||
| Graft infection | Infections and infestations | Systematic Assessment |
| ||
| Oesophageal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Ophthalmic herpes simplex | Infections and infestations | Systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pancreatic abscess | Infections and infestations | Systematic Assessment |
| ||
| Peritonitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Purulent discharge | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Pyuria | Infections and infestations | Systematic Assessment |
| ||
| Scrotal infection | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Streptococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Viral diarrhoea | Infections and infestations | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
| ||
| Anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Anastomotic ulcer | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cement embolism | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Confusion postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incarcerated incisional hernia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision site erythema | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Mental status changes postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pancreatic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Peripancreatic fluid collection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post procedural urine leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural nausea | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural vomiting | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stoma site discomfort | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stoma site extravasation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stoma site ischaemia | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Urostomy complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood bicarbonate increased | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood culture positive | Investigations | Systematic Assessment |
| ||
| Cholangiogram | Investigations | Systematic Assessment |
| ||
| Enterococcus test positive | Investigations | Systematic Assessment |
| ||
| Haematocrit decreased | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased | Investigations | Systematic Assessment |
| ||
| Oxygen saturation decreased | Investigations | Systematic Assessment |
| ||
| Transaminases increased | Investigations | Systematic Assessment |
| ||
| Troponin increased | Investigations | Systematic Assessment |
| ||
| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Alkalosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Electrolyte depletion | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Electrolyte imbalance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypervolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lactic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic alkalosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Compartment syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Akinesia | Nervous system disorders | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Chronic inflammatory demyelinating | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hemiparesis | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial hypotension | Nervous system disorders | Systematic Assessment |
| ||
| Multiple sclerosis relapse | Nervous system disorders | Systematic Assessment |
| ||
| Myoclonus | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
| ||
| Sciatica | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Device leakage | Product Issues | Systematic Assessment |
| ||
| Device occlusion | Product Issues | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Hallucination | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Bladder spasm | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Oliguria | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Vesical fistula | Renal and urinary disorders | Systematic Assessment |
| ||
| Ovarian vein thrombosis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Penile pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Intertrigo | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin necrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Abdominal cavity drainage | Surgical and medical procedures | Systematic Assessment |
| ||
| Abscess drainage | Surgical and medical procedures | Systematic Assessment |
| ||
| Biliary drainage | Surgical and medical procedures | Systematic Assessment |
| ||
| Nephrostomy | Surgical and medical procedures | Systematic Assessment |
| ||
| Vascular catheterisation | Surgical and medical procedures | Systematic Assessment |
| ||
| Wound drainage | Surgical and medical procedures | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Distributive shock | Vascular disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Peripheral artery thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Peripheral ischaemia | Vascular disorders | Systematic Assessment |
| ||
| Shock haemorrhagic | Vascular disorders | Systematic Assessment |
| ||
| Venous thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Wound secretion | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edwards Critical Care Clinical Affairs | Edwards Lifesciences | (949) 250-7169 | afmidestudy@edwards.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2018 | Jul 1, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018625 | Microscopy, Atomic Force |
| ID | Term |
|---|---|
| D020527 | Microscopy, Scanning Probe |
| D008853 | Microscopy |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| African American |
|
| White |
|
| Other |
|
| Not Reported |
|