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Oxygen Insufflation in Microlaryngoscopies

Oxygen Insufflation: How High Flow, Low Pressure Oxygen Can Replace Jet Ventilation in Appropriate Surgical Airway Cases

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04979533
Enrollment
0
Registered
2021-07-28
Start date
2023-01-01
Completion date
2023-05-30
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

Keywords

surgery, airway, hypoxia prevention, oxygen insufflation

Brief summary

The purpose of this project is to evaluate the efficacy of oxygen insufflation (continuous oxygen flow) to keep oxygen saturation (oxygen levels measured with a pulse oximeter \[finger device used in medicine\]) at 90% or greater in adult patients undergoing microlaryngoscopy surgery.

Detailed description

High flow, low pressure oxygen will be supplied in microlaryngoscopy airway surgery. These procedures are usually performed with jet ventilation (UAB) or intermittent apnea (surgery centers). Jet ventilation provides oxygenation with limited ventilation but come with high risks, such as barotrauma, pneumothorax, mucosa drying, and even death in the most severe cases. Intermittent apnea is a nuisance for the surgeon in that surgical time is often interrupted with having to place the endotracheal tube whenever the patient's oxygen saturation levels fall. The solution is oxygen insufflation, which will give extended oxygenation times for the surgeon to operate without the inherent risks associated with jet ventilation. During the procedure, oxygen tubing will be connected to the surgeon's laryngoscope instead of the jet ventilation tubing. Oxygen flows of 15 L/min will be administered through the laryngoscope to the posterior oropharynx. Endotracheal tube will be placed if oxygenation deemed insufficient due to oxygen saturations of \<90%. Endotracheal tube will be intermittently placed to check and correct carbon dioxide levels.

Interventions

DEVICEInsufflator oxygen tubing

high flow, low pressure oxygen with pressure relief valve and luer Lock connections delivered at 15 L/min through surgeon's laryngoscope.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention model description

There will be a single group of participants in which all receive oxygen insufflation to see if oxygen insufflation is adequate in microlaryngoscopy airway surgery.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* adult patients undergoing microlaryngoscopy surgery without a tracheostomy

Exclusion criteria

* patients who have a tracheostomy

Design outcomes

Primary

MeasureTime frameDescription
High flow, low pressure oxygen can increase apneic oxygenation time during airway procedures30-60 minutes15 liters per minute of oxygen will be administered to the posterior oropharynx.

Secondary

MeasureTime frameDescription
Degree of hypercapnia experienced by participants30-60 minutesMeasurement will be taken by intermittent ventilation by placing an endotracheal tube
Participants That Maintain Adequate Oxygenation at 90% or Greater30-60 minutesPulse oximetry will be used to measure oxygenation status

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026