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| Name | Class |
|---|---|
| National Aeronautics and Space Administration (NASA) | FED |
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Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP) ventilator approach using an FDA approved ventilator.
All study procedures will be performed in adult patients following informed consent at the endoscopy suite of the University of Utah Health Sciences Center in Salt Lake City, Utah. A ventilation mask will be placed on the patient's face and connected to the ventilator. Supplemental oxygen will be delivered by the ventilator through the mask; the concentration of oxygen delivered will be left to the clinician's discretion. A modified mask with multiple small leaks will be used with a standard elastomeric H-strap to secure it to the patient's face.
The endoscopy suite nurse and technicians will attach all clinically necessary standard sensors and connect them to the patient and monitoring system. Height, weight, and neck circumference will be measured and recorded digitally on an encrypted laptop. In addition to the standard of care monitors, the investigators will collect data from additional non-invasive modalities and save the data to a laptop using custom software for later analysis.
Pressure and flow sensors included in the ventilator will be used to monitor the patients' tidal volumes and respiratory rate during the procedure. The data that will be collected and recorded on the laptop will include: RIP data, mask pressure, flow, and breath rate. An additional flow sensor will be placed in line with the ventilator.
The objective of this study is threefold: Demonstrate in patients undergoing procedural sedation (e.g., for colonoscopy) that obstructive apnea can successfully be avoided by stenting the airway open using CPAP, demonstrate that we can successfully detect periods of zero ventilation, and demonstrate the functionality of the modified standard mask.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noninvasive Ventilation | Experimental | Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive Ventilator (V60, Philips) | Device | The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Time the Patient Will Experience Apnea | Length of time in minutes the patient experiences apnea divided by the length of time of the diagnostic procedure (Unit: %) | Duration of Diagnostic Procedure (Colonoscopy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai Kuck, Ph.D. | University of Utah | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Noninvasive Ventilation | Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator. Noninvasive Ventilator (V60, Philips): The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Noninvasive Ventilation | Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator. Noninvasive Ventilator (V60, Philips): The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Time the Patient Will Experience Apnea | Length of time in minutes the patient experiences apnea divided by the length of time of the diagnostic procedure (Unit: %) | Posted | Median | Inter-Quartile Range | % time in apnea of total study duration | Duration of Diagnostic Procedure (Colonoscopy) |
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Participation and adverse event reporting was limited to the study intervention, mean of 24 minutes (SD 11).
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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 | Noninvasive Ventilation | Use of the Noninvasive Ventilator (V60, Philips). The ventilator mask will be placed on the patient's face according to their comfort using an elastomeric H-strap. CPAP of 8 cmH2O (pressure) will be the starting setting for the ventilator. Noninvasive Ventilator (V60, Philips): The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used. |
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This was not a randomized clinical trial involving multiple facilities.
The pharmacodynamic effect of the sedation were unknown.
The CPAP machine and the tight-fitting mask may have provided enough of a stimulus as to maintain the patient in a lighter sedation state.
The proprietary C-flex and Auto-Trak algorithms are integrated into the V60 ventilator and could not be disabled. The algorithms did cause some variation in pressure levels delivered to the patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kai Kuck, PhD | University of Utah | 8012051010 | kai.kuck@hsc.utah.edu |
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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 | Sep 30, 2015 | Nov 2, 2020 | Prot_SAP_000.pdf |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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