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NCT05090852

High Velocity Nasal Insufflation (Hi-VNI) Use in Upper Airway Surgery

Completed NA Results posted Last updated 13 October 2022
What this trial tests

NA trial testing Hi-VNI in Upper Airway Surgery in 31 participants. Completed in 30 September 2021.

Timeline
22 October 2020
Primary endpoint
30 September 2021
30 September 2021

Quick facts

Lead sponsorNatasha Mirza
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment31
Start date22 October 2020
Primary completion30 September 2021
Estimated completion30 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Natasha Mirza

Who can join

22 and older, any sex, with Upper Airway Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation Primary · 1 day

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.

GroupValue95% CI
Patients With HVNI and Patients With Intubation19
Patients With HVNI and Patients With Intubation7
Patients With HVNI and Patients With Intubation5

Sponsor's own description

The goals of this study are to establish the efficacy of Hi-VNI (High Velocity Nasal Insufflation) in upper airway surgery from the anesthesiologist's and surgeon's perspectives, and to describe the ideal patient and the ideal pathology as well as suitable clinical scenarios when this oxygenation technique should be selected.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05090852.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing