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Recruiting NCT05881863

To Investigate Airway Oxygen Concentrations During Rigid Bronchoscopy Procedures Performed With High Frequency Jet Ventilation

Observational Central Airway Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Central Airway Obstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Thermal ablation (use of treatment modalities that generate heat) has become a widely used tool for treatment of central airway obstruction (e.g. laser, electrocautery, radiofrequency, and argon plasma coagulation). However, this method carries with it an increased risk for airway fire - a surgical fire that occurs in a patient's airway and could also include a fire in the attached breathing circuit. To decrease the risk of airway fire during mechanical ventilation with an endotracheal tube, the concentration of inspired oxygen (FiO2) is set below 40% while waiting for end tidal oxygen concentration (EtO2) to fall below 40% prior to starting thermal ablation. There is no published literature describing O2 concentration within the airways (AiO2) during jet ventilation with rigid bronchoscopy. The co-investigators of this study have recently collected data on AiO2 during rigid bronchoscopy using manual low frequency jet ventilation/high frequency jet ventilation with a period of apnea. The intent of this study is to measure the time taken for the central airway oxygen concentration to drop from 90 to 40% when the "laser mode" is activated on the Monsoon jet ventilator. Ventilation is continued during "laser mode."

Interventions

  • Other No intervention
    This is an observational study

Primary outcome measures

  • Time in seconds to AiO2 from 90 to 40% [Time frame: baseline]
Secondary outcome measures (1)
  • Differences in time to laser mode AiO2 [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • Patients undergoing rigid bronchoscopy for treatment of central airway obstruction at FV UMMC will be identified.
  • 18 years or older
  • Need rigid bronchoscopy as pre-determined by the interventional pulmonologist

Exclusion criteria

  • Refusal to sign consent
  • Pregnant patients
  • Hemodynamic instability defined as continuous infusion of medication in order to support blood pressure and/or heart rate/rhythm
  • Respiratory instability defined as SpO2\<90% with \>90% supplemental oxygen.
  • Ineligible for rigid bronchoscopic intubation
  • Latex allergy
  • Evidence of fistulous airway
  • Active Bronchopleural fistula

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT05881863 · ANES-2022-31377

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗