Trial Outcomes & Findings for Electric Blower Based Ventilator Used During Procedural Sedation (NCT NCT02621463)
NCT ID: NCT02621463
Last Updated: 2021-04-27
Results Overview
Length of time in minutes the patient experiences apnea divided by the length of time of the diagnostic procedure (Unit: %)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
Duration of Diagnostic Procedure (Colonoscopy)
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Noninvasive Ventilation
n=29 Participants
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.
|
|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 11 • n=29 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
|
Body mass index
|
27 kg/m^2
STANDARD_DEVIATION 6 • n=29 Participants
|
PRIMARY outcome
Timeframe: 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: %)
Outcome measures
| Measure |
Noninvasive Ventilation
n=29 Participants
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.
|
|---|---|
|
Percentage of Time the Patient Will Experience Apnea
|
11 % time in apnea of total study duration
Interval 4.0 to 22.0
|
Adverse Events
Noninvasive Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place