Trial Outcomes & Findings for An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy (NCT NCT02310230)
NCT ID: NCT02310230
Last Updated: 2024-06-25
Results Overview
Minute ventilation (or respiratory minute volume) is defined as the volume of air that can be inhaled or exhaled during one minute. The ExSpiron Respiratory Variation Monitor is able to quantify respiratory rate and also determine tidal volume and minute ventilation. The monitor measures a patient's baseline minute ventilation (MV) at the beginning of the case, and then compares subsequent minute volumes to that baseline, measured as a percentage of the baseline. In that respect, the minute ventilation (MV) values can often exceed 100 percent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
Duration of procedure: Approximately 60 minutes
Results posted on
2024-06-25
Participant Flow
Participant milestones
| Measure |
Blinded Group
Data from the ExSpiron Respiratory Variation Monitor (minute ventilation, tidal volume, and respiratory rate) will not be displayed. The anesthesia provider will care for the patient in the usual manner.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
Monitor Group
The ExSpiron Respiratory Variation Monitor will display continuous real-time measurements of minute ventilation, tidal volume, and respiratory rate, and the anesthesia provider will be instructed to utilize this information in the care of the patient as they deem appropriate.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
41
|
32
|
|
Overall Study
NOT COMPLETED
|
9
|
18
|
Reasons for withdrawal
| Measure |
Blinded Group
Data from the ExSpiron Respiratory Variation Monitor (minute ventilation, tidal volume, and respiratory rate) will not be displayed. The anesthesia provider will care for the patient in the usual manner.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
Monitor Group
The ExSpiron Respiratory Variation Monitor will display continuous real-time measurements of minute ventilation, tidal volume, and respiratory rate, and the anesthesia provider will be instructed to utilize this information in the care of the patient as they deem appropriate.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
3
|
|
Overall Study
monitor baseline taken after induction
|
2
|
7
|
|
Overall Study
Poor signal quality
|
5
|
8
|
|
Overall Study
Case cancelled
|
1
|
0
|
Baseline Characteristics
An Evaluation of the Utility of the ExSpiron Respiratory Variation Monitor During Upper GI Endoscopy
Baseline characteristics by cohort
| Measure |
Blinded Group
n=41 Participants
Data from the ExSpiron Respiratory Variation Monitor (minute ventilation, tidal volume, and respiratory rate) will not be displayed. The anesthesia provider will care for the patient in the usual manner.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
Monitor Group
n=32 Participants
The ExSpiron Respiratory Variation Monitor will display continuous real-time measurements of minute ventilation, tidal volume, and respiratory rate, and the anesthesia provider will be instructed to utilize this information in the care of the patient as they deem appropriate.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
60.5 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 15.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Height
|
169.5 centimeters
STANDARD_DEVIATION 9.7 • n=5 Participants
|
169.3 centimeters
STANDARD_DEVIATION 12.0 • n=7 Participants
|
169.4 centimeters
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Weight
|
82.1 kilograms
STANDARD_DEVIATION 23.8 • n=5 Participants
|
75.3 kilograms
STANDARD_DEVIATION 17.1 • n=7 Participants
|
79.1 kilograms
STANDARD_DEVIATION 21.4 • n=5 Participants
|
|
BMI
|
28.3 kg/m^2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Length of Procedure
|
30.1 minutes
STANDARD_DEVIATION 1.9 • n=5 Participants
|
37.2 minutes
STANDARD_DEVIATION 3.2 • n=7 Participants
|
33.2 minutes
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Intra-Op Propofol
|
239.7 mcg/kg/min
STANDARD_DEVIATION 108.2 • n=5 Participants
|
241.4 mcg/kg/min
STANDARD_DEVIATION 112.6 • n=7 Participants
|
240.4 mcg/kg/min
STANDARD_DEVIATION 110.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of procedure: Approximately 60 minutesMinute ventilation (or respiratory minute volume) is defined as the volume of air that can be inhaled or exhaled during one minute. The ExSpiron Respiratory Variation Monitor is able to quantify respiratory rate and also determine tidal volume and minute ventilation. The monitor measures a patient's baseline minute ventilation (MV) at the beginning of the case, and then compares subsequent minute volumes to that baseline, measured as a percentage of the baseline. In that respect, the minute ventilation (MV) values can often exceed 100 percent.
Outcome measures
| Measure |
Blinded Group
n=41 Participants
Data from the ExSpiron Respiratory Variation Monitor (minute ventilation, tidal volume, and respiratory rate) will not be displayed. The anesthesia provider will care for the patient in the usual manner.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
Monitor Group
n=32 Participants
The ExSpiron Respiratory Variation Monitor will display continuous real-time measurements of minute ventilation, tidal volume, and respiratory rate, and the anesthesia provider will be instructed to utilize this information in the care of the patient as they deem appropriate.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
|---|---|---|
|
Average Minute Ventilation in Patients Cared for Using the ExSpiron Respiratory Variation Monitor (RVM) Compared to Patients With Routine Monitoring in Patients Undergoing Upper Gastrointestinal Endoscopy
|
86.7 % of minute ventilation baseline
Standard Error 5.9
|
109.8 % of minute ventilation baseline
Standard Error 9.3
|
SECONDARY outcome
Timeframe: Duration of procedure: Approximately 60 minutesOutcome measures
| Measure |
Blinded Group
n=41 Participants
Data from the ExSpiron Respiratory Variation Monitor (minute ventilation, tidal volume, and respiratory rate) will not be displayed. The anesthesia provider will care for the patient in the usual manner.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
Monitor Group
n=32 Participants
The ExSpiron Respiratory Variation Monitor will display continuous real-time measurements of minute ventilation, tidal volume, and respiratory rate, and the anesthesia provider will be instructed to utilize this information in the care of the patient as they deem appropriate.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
|---|---|---|
|
Incidence of Airway Maneuvers Required to Maintain Ventilation in Each Group
|
2.2 one airway maneuver
Interval 0.0 to 7.0
|
2.3 one airway maneuver
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Duration of Procedure: Approximately 60 MinutesPercentage of procedure time spent with Minute Ventilation less than 40% of the Minute Ventilation Baseline. Minute ventilation (or respiratory minute volume) is defined as the volume of air that can be inhaled or exhaled during one minute. The ExSpiron Respiratory Variation Monitor is able to quantify respiratory rate and also determine tidal volume and minute ventilation.
Outcome measures
| Measure |
Blinded Group
n=41 Participants
Data from the ExSpiron Respiratory Variation Monitor (minute ventilation, tidal volume, and respiratory rate) will not be displayed. The anesthesia provider will care for the patient in the usual manner.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
Monitor Group
n=32 Participants
The ExSpiron Respiratory Variation Monitor will display continuous real-time measurements of minute ventilation, tidal volume, and respiratory rate, and the anesthesia provider will be instructed to utilize this information in the care of the patient as they deem appropriate.
ExSpiron Respiratory Variation Monitor: Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
|
|---|---|---|
|
Time With Low Minute Ventilation
|
15.3 percentage of procedure duration
Standard Error 2.8
|
7.1 percentage of procedure duration
Standard Error 1.4
|
Adverse Events
Blinded Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Monitor Group
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
Alexander Friend, Clinical Research Coordinator
University of Vermont Medical Center
Phone: 802-847-4259
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place