Upper Airway SurgeryNCT05090852
High Velocity Nasal Insufflation (Hi-VNI) Use in Upper Airway Surgery
A study testing Hi-VNI in people with Upper Airway Surgery, run by Natasha Mirza at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Upper Airway Surgery
- What is being tested?
- Hi-VNI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo elective upper airway surgery at the University of Pennsylvania
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Upper Airway Surgery
- Being tested
- Hi-VNI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-VNIDevice
Hi-VNI used instead of or along with endotracheal intubation or jet ventilation to provide oxygen to patients during upper airway surgery
| Study group | Role | What they receive |
|---|---|---|
| Hi-VNI as primary or adjunct oxygenation technique | Experimental | Hi-VNI used as a primary or adjunct oxygenation technique during upper airway surgery Receives: Device: Hi-VNI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start22 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Airway SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natasha Mirza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Natasha Mirza, University of Pennsylvania
- Investigators
- Natasha Mirza, MD, Principal investigator, Department of Otorhinolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090852
- Sponsor's protocol ID
- 834412
- Status last verified
- Sep 2022
- First submitted
- 11 Oct 2021
- Last updated
- 13 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Velocity Nasal Insufflation (Hi-VNI) Use in Upper Airway Surgery
- ClinicalTrials.gov ID
- NCT05090852
- Acronym / sponsor ID
- 834412
- Conditions
- Upper Airway Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Natasha MirzaUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Posted 19 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hi-VNI as primary or adjunct oxygenation technique | Experimental | Device: Hi-VNIHi-VNI used as a primary or adjunct oxygenation technique during upper airway surgery |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled to undergo elective upper airway surgery at the University of Pennsylvania
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hi-VNIHi-VNI used instead of or along with endotracheal intubation or jet ventilation to provide oxygen to patients during upper airway surgery | Device | Hi-VNI as primary or adjunct oxygenation technique |
Primary outcome
Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha Mirza, MD principal investigator
Department of Otorhinolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hi-VNI in people with Upper Airway Surgery, run by Natasha Mirza at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Case Completion Rate Using HVNI With or Without Converting to Alternative Mode of Oxygenation (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.