Trial Outcomes & Findings for Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) and Diagnostic Bronchoscopy (NCT NCT03086408)
NCT ID: NCT03086408
Last Updated: 2020-07-17
Results Overview
Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Duration of surgery (average approximately 1 hour)
Results posted on
2020-07-17
Participant Flow
Participant milestones
| Measure |
THRIVE
Participants receive Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
Participants receive tracheal intubation or supraglottic airway device for mechanical 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
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 19.01 • n=10 Participants
|
56.5 years
STANDARD_DEVIATION 16.17 • n=10 Participants
|
55.0 years
STANDARD_DEVIATION 17.24 • n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)
|
94.7 percentage of oxygen
Standard Deviation 6.65
|
98.7 percentage of oxygen
Standard Deviation 1.70
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Awakening/Extubation Time
|
10.1 minutes
Standard Deviation 2.42
|
9.2 minutes
Standard Deviation 4.87
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from the moment of the introduction of the bronchoscope in patient's mouth to tracheal placement.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Time to Bronchoscope Placement in Trachea
|
1.03 minutes
Standard Deviation 0.38
|
1.1 minutes
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Number of Tracheal Bronchoscope Placements Required
|
0.2 placements
Standard Deviation 0.42
|
0.6 placements
Standard Deviation 1.07
|
PRIMARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from the introduction of the bronchoscope in patient's mouth to withdrawing the bronchoscope at the completion of procedure.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Duration of Procedure
|
15.6 minutes
Standard Deviation 7.90
|
15.5 minutes
Standard Deviation 11.17
|
SECONDARY outcome
Timeframe: Duration of surgery (average approximately 1 hour)Recorded from patient's admission to the post-anesthesia care unit (PACU) to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Time to Patient Being Alert and Oriented x 4
|
1.2 minutes
Standard Deviation 3.12
|
0.67 minutes
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Duration of recovery room stay (average approximately 1 hour)From admission to recovery room, to discharge from recovery room
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Recovery Room Discharge-ready Time
|
30.3 minutes
Standard Deviation 17.09
|
16.6 minutes
Standard Deviation 8.38
|
SECONDARY outcome
Timeframe: Duration of recovery room stay (average approximately 1 hour)Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable).
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
First Pain Score in Recovery Room
|
1.3 score on a scale
Standard Deviation 2.41
|
1.3 score on a scale
Standard Deviation 2.41
|
SECONDARY outcome
Timeframe: Day of discharge (up to 2 minutes)Pain was measured using an 11-point visual analogue scale (VAS). Range: 0-11 (0 = no pain; 11 = worst pain imaginable).
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Discharge-ready Pain Score
|
1.1 score on a scale
Standard Deviation 1.66
|
1.3 score on a scale
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: Recovery room to 7th postoperative dayAnalgesic consumption was measured in oral morphine milligram equivalents (MME)
Outcome measures
| Measure |
THRIVE
n=10 Participants
Participants receive THRIVE active nasal oxygen delivery system.
|
Endotracheal Tube or Supraglottic Airway
n=10 Participants
Participants receive tracheal intubation or supraglottic airway device for mechanical ventilation.
|
|---|---|---|
|
Analgesic Consumption
|
0.5 MME
Standard Deviation 1.58
|
2 MME
Standard Deviation 4.83
|
Adverse Events
THRIVE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endotracheal Tube or Supraglottic Airway
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