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

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.

Study Overview

• Status: Completed
• Conditions: Upper Airway Surgery
• Intervention / Treatment: Device: Hi-VNI

Detailed Description

The most challenging aspects of laryngeal and laryngotracheal procedures are difficulty of exposure and airway management. These procedures require use of microlaryngeal instruments through a small lumen of a rigid laryngoscope, and are oftentimes difficult to perform with a standard endotracheal tube in place. Similarly, when performing endoscopic evaluation of the trachea, access to the space and visualization of the entire 360-degree view of the trachea is crucial.

To overcome these challenges, a number of techniques for oxygen delivery have evolved over time. Among them are use of a small endotracheal tube, use of jet ventilation and intermittent apnea with periodic removal of the endotracheal tube. The aforementioned methods of airway management carry inherent risks of airway injury, can be accompanied by brief periods of hypoxia or hypercarbia, and can sometimes lead to tenuous airway management scenarios for both the surgeon and the anesthesiologist when clear communication and familiarity with the airway management plan during the procedure are sub-optimal. For this reason, there is an ongoing search for acceptable solutions to minimize these risks during upper airway surgery.

One of the newly emerging advanced oxygenation techniques, also known as Hi-VNI (High Velocity Nasal Insufflation), allows for delivery of humidified oxygen through a specialized high-flow nasal cannula at rates of up to 40 l/min. This non-invasive high flow respiratory support system is currently being used in the treatment of respiratory failure in both adult and pediatric patients. This technique provides sustained oxygenation due to reduction in airway resistance, a build-up of airway pressure with oxygen-rich gas and active gas exchange, which lead to flushing of anatomic dead space, and delivery of oxygen into the lungs. This oxygenation technique can be used both in spontaneously breathing patients and under apneic conditions, while providing an unobstructed surgical view with the glottis, subglottis and trachea fully accessible for instrumentation.

The goal of this study is to establish the efficacy of Hi-VNI in upper airway surgery, to document the advantages and disadvantages of this technique from the standpoint of the airway surgeon and the anesthesiologist, and to provide more information about the optimal patient and airway pathology as well as suitable clinical scenarios when Hi-VNI device can be used for oxygenation during upper airway surgery. The researchers hypothesize that in appropriate clinical situations, Hi-VNI can ease airway management, shorten case duration, and provide superior operating conditions including space for instrumentation during upper aerodigestive tract procedures.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled to undergo elective upper airway surgery at the University of Pennsylvania

Exclusion Criteria:

• Underlying medical conditions in which brief periods of hypoxemia or hypercarbia are not well tolerated
• Coronary artery disease
• Severe heart failure with EF < 40% or implanted ICD
• Pulmonary hypertension or pulmonary fibrosis
• History of increased intracranial pressure
• History of skull base or intracranial surgery
• Severe nasal obstruction
• Extremely low or extremely high BMI (BMI <16 or >40)
• At high risk for aspiration
• Taken to OR for urgent or emergent upper airway surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hi-VNI as primary or adjunct oxygenation technique; Hi-VNI used as a primary or adjunct oxygenation technique during upper airway surgery	Device: Hi-VNI; Hi-VNI used instead of or along with endotracheal intubation or jet ventilation to provide oxygen to patients during upper airway surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation	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.	1 day

Collaborators and Investigators

• Sponsor: Natasha Mirza
• Investigators: Principal Investigator: Natasha Mirza, MD, Department of Otorhinolaryngology - Head and Neck Surgery

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 834412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes