Apnea During Procedural Sedation
Conditions
Brief summary
Conduct human trials in the endoscopy suite of our continuous positive airway pressure (CPAP) ventilator approach using an FDA approved ventilator.
Detailed description
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.
Interventions
DEVICENoninvasive 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.
Sponsors
National Aeronautics and Space Administration (NASA)
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years of age * undergoing a colonoscopy procedure * receiving registered nurse-administered procedural sedation at the University of Utah Health Sciences Center * agree to participate * written informed consent
Exclusion criteria
* Inability/refusal of subject to provide informed consent. * Standard colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time the Patient Will Experience Apnea | Duration of Diagnostic Procedure (Colonoscopy) | Length of time in minutes the patient experiences apnea divided by the length of time of the diagnostic procedure (Unit: %) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Noninvasive Ventilation | — |
|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 11 | — |
| Body mass index | 27 kg/m^2 STANDARD_DEVIATION 6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 29 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
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: %)
Time frame: Duration of Diagnostic Procedure (Colonoscopy)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Noninvasive Ventilation | Percentage of Time the Patient Will Experience Apnea | 11 % time in apnea of total study duration |