Comparing two ventilation methods during laryngotracheal surgery
Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
This study is testing which breathing method, Flow Controlled Ventilation or High-Frequency Jet Ventilation, works better for protecting the lungs during laryngotracheal surgery in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva) |
| Trial ID | NCT06063798 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the respiratory effects of two ventilation techniques, Flow Controlled Ventilation (FCV) and High-Frequency Jet Ventilation (HFJV), in patients undergoing laryngotracheal surgery under general anesthesia. The study is randomized and controlled, enrolling 50 adult patients who will be assigned to either the FCV or HFJV group. Measurements of lung function and respiratory mechanics will be taken before and after surgery to assess the effectiveness of each ventilation method. The goal is to determine which technique provides better lung protection and ventilation efficiency during the procedure.
Who should consider this trial
Good fit: Ideal candidates are adult patients scheduled for elective laryngotracheal surgery under general anesthesia.
Not a fit: Patients with severe heart or respiratory diseases, obesity, or those requiring tracheotomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies that enhance lung protection during laryngotracheal surgeries.
How similar studies have performed: While the approach of using FCV is relatively novel, previous studies have indicated potential benefits of advanced ventilation techniques in similar surgical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent signed by the subject * General anesthesia for laryngotracheal surgery * Adult patients, female and male, over 18 years of age * Elective surgery Exclusion Criteria: * Documented severe heart conditions (New York Heart Association Class 4, severe pulmonary hypertension) * Documented severe respiratory disease (uncontrolled asthma, severe pulmonary fibrosis, chronic obstructive pulmonary disease GOLD 4) * Documented severe Neurological diseases (Acute ischemic and hemorrhagic stroke within the preceding 3 months, uncontrolled seizures) * Surgery that requires tracheotomy * Obesity (Body Mass Index ≥ 30 kg/m2) * Inability to follow the procedures of the study (mental condition or language barrier e.g. incomprehension of French language) * Previous enrolment into the current study or other study that involves unknown medication in the past 12 months * Allergy or contraindication to Propofol and/or Remifentanil and/or Rocuronium
Where this trial is running
Geneva
- Geneva University Hospitals — Geneva, Switzerland (Recruiting)
Study contacts
- Principal investigator: Gergely Albu, MD, PhD — University Hospital, Geneva
- Study coordinator: Gergely Albu, MD, PhD
- Email: gergely.albu@hcuge.ch
- Phone: 0041795532052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.