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| Name | Class |
|---|---|
| United States Air Force | FED |
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A randomized, multi-center trial involving critically-ill patients comparing conventional, manual control of inspired oxygen (FiO2) within a target range, with a computer-controlled, closed-loop FiO2 delivery using a continuous ventilator.
The trial will use a proportional-integral-derivative (PID) type controller for automatic adjustment of FiO2 to maintain the SpO2 within a target range, based on continuous use of pulse oximetry. Intubated subjects will be randomized to either manual control of FiO2 or closed-loop control of FiO2, during a 12-hour period. The PCLC is designed to respond to acute hypoxemia (SpO2 <88%) within seconds while preventing hypoxemia and minimizing exposure to excessive inspired oxygen levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed Loop Control Ventilation | Experimental | automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software |
|
| Manual Control Ventilation | Active Comparator | manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed Loop Control Ventilation | Device | Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours] | Relative duration is (time within SpO2 target of 92-96%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the 92 - 96% range divided by 12 hours with arcsin square root transformation | 12 hours |
| Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device | Number of participants with SpO2 less than 88% at anytime while on study device | 24 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Duration of Time With SpO2 92 to 96% When FiO2 is Greater Than 21% and SpO2 is Greater Than or Equal to 92% When Fi02 "Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours] | Relative duration is (time within SpO2 target of either a) 92-96% when FiO2 is greater than 21% or b) greater than or equal to 92% when FiO2 equals 21%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the range divided by 12 hours with arcsin square root transformation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Closed Loop Control Ventilation | automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software |
| FG001 | Manual Control Ventilation | manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Closed Loop Control Ventilation | automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software |
| BG001 | Manual Control Ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours] | Relative duration is (time within SpO2 target of 92-96%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the 92 - 96% range divided by 12 hours with arcsin square root transformation | Posted | Mean | Standard Deviation | arbitrary units | 12 hours |
|
From enrollment until 24 hours after study device discontinuation, a period of 36 to 48 hours after study device placement.
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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 | Closed Loop Control Ventilation | automatic adjustment of the ZOLL 731 ventilator FiO2 by the closed loop control software Closed Loop Control Ventilation: Closed loop control ventilation using ZOLL 731 ventilator with physiologic closed-loop control software |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathan Burkhart | ZOLL | 763.367.0462 | nburkhart@zoll.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 | Dec 9, 2019 | Feb 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Manual Control Ventilation | Device | Manual control ventilation using ZOLL 731 ventilator |
|
| 12 hours |
| Physician Decision |
|
| Withdrawal by Subject |
|
manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Manual Control Ventilation |
manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator |
|
|
| Primary | Number of Participants With SpO2 Less Than 88% at Anytime While on Study Device | Number of participants with SpO2 less than 88% at anytime while on study device | Posted | Count of Participants | Participants | 24 hours after intervention |
|
|
|
| Secondary | Relative Duration of Time With SpO2 92 to 96% When FiO2 is Greater Than 21% and SpO2 is Greater Than or Equal to 92% When Fi02 "Relative Duration With Oxygen Saturation (SpO2) Within Target Range [Time Frame: 12 Hours] | Relative duration is (time within SpO2 target of either a) 92-96% when FiO2 is greater than 21% or b) greater than or equal to 92% when FiO2 equals 21%)/12 hours where higher value demonstrates better ability of FiO2 control method to maintain appropriate oxygen saturation. Relative time the patient's SpO2 was maintained within target over the 12 hours on the study device, calculated as total time each patient had SpO2 within the range divided by 12 hours with arcsin square root transformation | Posted | Mean | Standard Deviation | arbitrary units | 12 hours |
|
|
|
| 0 |
| 104 |
| 0 |
| 104 |
| 24 |
| 104 |
| EG001 | Manual Control Ventilation | manual adjustment of the ZOLL 731 ventilator FiO2 by the treatment team based on physician order Manual Control Ventilation: Manual control ventilation using ZOLL 731 ventilator | 2 | 102 | 9 | 102 | 17 | 102 |
| Atrial fibrillation with rapid ventricular response | Cardiac disorders | Non-systematic Assessment |
|
| Cerebral Edema | Nervous system disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Intracerbral hemorrhage | Nervous system disorders | Non-systematic Assessment |
|
| Multi organ failure | General disorders | Non-systematic Assessment |
|
| Pericardial Tamponade | Cardiac disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Subarachnoid hemorrhage | Vascular disorders | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Bacteremia | Infections and infestations | Non-systematic Assessment |
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| Clostridium Difficle Infection | Infections and infestations | Non-systematic Assessment |
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| Coffee ground emesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Device removal failed | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fever | Infections and infestations | Non-systematic Assessment |
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| gastric dilation | Gastrointestinal disorders | Non-systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypotension | Vascular disorders | Non-systematic Assessment |
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| Hypovolemia | Vascular disorders | Non-systematic Assessment |
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| Hypoxemia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Leukocytosis | Immune system disorders | Non-systematic Assessment |
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| Lung consolidation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Mental status change | Nervous system disorders | Non-systematic Assessment |
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| Metabolic Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Neurological examination abnormal | Nervous system disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Premature ventricular contractions | Cardiac disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Renal replacement therapy | Renal and urinary disorders | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Swelling of eyelid | Eye disorders | Non-systematic Assessment |
|
| Troponin increase | Cardiac disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| VIIth nerve paralysis | Nervous system disorders | Non-systematic Assessment |
|
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