Trial Outcomes & Findings for Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Short Laryngologic Surgery (NCT NCT03091179)
NCT ID: NCT03091179
Last Updated: 2020-03-04
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
intraoperative (up to one hour)
Results posted on
2020-03-04
Participant Flow
Participant milestones
| Measure |
THRIVE
THRIVE: active nasal oxygen delivery system
|
Control Group
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 12.42 • n=10 Participants
|
55.2 years
STANDARD_DEVIATION 17.29 • n=10 Participants
|
53.1 years
STANDARD_DEVIATION 14.82 • n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: intraoperative (up to one hour)Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)
|
93 percentage of saturation (SpO2)
Standard Deviation 5.66
|
98.7 percentage of saturation (SpO2)
Standard Deviation 1.57
|
PRIMARY outcome
Timeframe: intraoperative (up to 20 min)time from end of surgery to responding to commands/extubation
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Time to Awakening From Anesthesia (Primary Anesthesia Outcome)
|
10.3 minutes
Standard Deviation 4.0
|
9.4 minutes
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: intraoperative (up to 5 min)Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Suspension Time (Primary Surgical Outcome)
|
1.8 minutes
Standard Deviation 1.1
|
4.3 minutes
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: intraoperative (up to 5 min)Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)
|
0.4 maneuvers
Standard Deviation 0.52
|
1.7 maneuvers
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: intraoperative (up to one hour)Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Duration of Surgery (Primary Surgical Outcome)
|
19.1 minutes
Standard Deviation 10.82
|
20.9 minutes
Standard Deviation 8.85
|
SECONDARY outcome
Timeframe: Recovery room admission (up to 30 min following admission to recovery room)Time required for the patient to become fully alert and oriented per standard recovery room evaluation
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Alertness
|
4.3 minutes
Standard Deviation 6.3
|
4.8 minutes
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Up to 2 hours after procedureOutcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Recovery Room Time
|
65.7 minutes
Standard Deviation 43.41
|
77.7 minutes
Standard Deviation 42.84
|
SECONDARY outcome
Timeframe: Recovery room admission and discharge (up to 2 hours)A score from 0 to 10, higher scores corresponding to higher pain
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Numerical Pain Rating Scores
recovery room admission
|
1.3 score on a scale
Standard Deviation 1.95
|
3.7 score on a scale
Standard Deviation 2.91
|
|
Numerical Pain Rating Scores
recovery room discharge
|
0.9 score on a scale
Standard Deviation 1.29
|
2.7 score on a scale
Standard Deviation 1.77
|
SECONDARY outcome
Timeframe: Recovery room admission and discharge (up to 2 hours)Total oral opioid consumption in morphine milligram equivalents
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Opioid Consumption
|
8.8 MME: morphine milligram equivalents
Standard Deviation 11.0
|
22.5 MME: morphine milligram equivalents
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Preoperative assessment and one month after surgerynumerical scale, range from 0 to 40, with higher scores corresponding to worse outcome
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Change in Voice Handicap Index (VHI)
preoperative
|
12.8 score on a scale
Standard Deviation 12.63
|
22.7 score on a scale
Standard Deviation 12.06
|
|
Change in Voice Handicap Index (VHI)
one month after surgery
|
7.6 score on a scale
Standard Deviation 12.19
|
13.6 score on a scale
Standard Deviation 13.22
|
SECONDARY outcome
Timeframe: One week after surgery15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.
Outcome measures
| Measure |
THRIVE
n=10 Participants
THRIVE: active nasal oxygen delivery system
|
Control Group
n=10 Participants
Endotracheal tube or Supraglottic jet ventilation
|
|---|---|---|
|
Quality of Recovery
|
142.5 score on a scale
Standard Deviation 15.7
|
131.2 score on a scale
Standard Deviation 17.9
|
Adverse Events
THRIVE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place