Trial Outcomes & Findings for High Velocity Nasal Insufflation (Hi-VNI) Use in Upper Airway Surgery (NCT NCT05090852)
NCT ID: NCT05090852
Last Updated: 2022-10-13
Results Overview
For each case, the ability to complete the surgical procedure with use of only Hi-VNI device for oxygenation will be assessed. Patients were oxygenated with Hi-VNI at a flow rate of 40 L/min and FiO2 of 100%. Patients with spO2 \< 93 or TcCO2 \> 65 during the procedure were converted to an alternative means of oxygenation, including mask ventilation and endotracheal intubation. The primary outcome measure is the surgical case completion rate with or without converting to alternate means of oxygenation.
COMPLETED
NA
31 participants
1 day
2022-10-13
Participant Flow
Participant milestones
| Measure |
Hi-VNI as Primary or Adjunct Oxygenation Technique
Hi-VNI used as a primary or adjunct oxygenation technique during upper airway surgery
Hi-VNI: Hi-VNI used instead of or along with endotracheal intubation or jet ventilation to provide oxygen to patients during upper airway surgery
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Hi-VNI as Primary or Adjunct Oxygenation Technique
Hi-VNI used as a primary or adjunct oxygenation technique during upper airway surgery
Hi-VNI: Hi-VNI used instead of or along with endotracheal intubation or jet ventilation to provide oxygen to patients during upper airway surgery
|
|---|---|
|
Overall Study
Physician Decision
|
5
|
Baseline Characteristics
High Velocity Nasal Insufflation (Hi-VNI) Use in Upper Airway Surgery
Baseline characteristics by cohort
| Measure |
Hi-VNI as Primary or Adjunct Oxygenation Technique
n=31 Participants
Hi-VNI used as a primary or adjunct oxygenation technique during upper airway surgery
Hi-VNI used instead of or along with endotracheal intubation or jet ventilation to provide oxygen to patients during upper airway surgery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Adult patients undergoing upper airway surgery who received HVNI, We compared patients who successfully completed their anesthesia for the surgical case with HVNI vs patients who had to be intubated.
For each case, the ability to complete the surgical procedure with use of only Hi-VNI device for oxygenation will be assessed. Patients were oxygenated with Hi-VNI at a flow rate of 40 L/min and FiO2 of 100%. Patients with spO2 \< 93 or TcCO2 \> 65 during the procedure were converted to an alternative means of oxygenation, including mask ventilation and endotracheal intubation. The primary outcome measure is the surgical case completion rate with or without converting to alternate means of oxygenation.
Outcome measures
| Measure |
Patients With HVNI and Patients With Intubation
n=31 Participants
Patients who completed their anesthesia with HVNI and patients who were switched to intubation
|
|---|---|
|
Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation
Total number of patients who successfully received HVNI only
|
19 Participants
|
|
Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation
Number of patients who received HVNI and also required conversion to alternate oxygenation
|
7 Participants
|
|
Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation
Number of patients who were enrolled but did not receive HVNI
|
5 Participants
|
Adverse Events
Patients With HVNI and Patients With Intubation
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