Anesthesia, General Clinical Trial
— FlowjetOfficial title:
Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
Laryngotracheal surgery often requires a small diameter endotracheal tube to oxygenate patients under general anesthesia. Oxygenation is often only possible with high-frequency jet ventilators due to the use of small diameter and high resistance airway cannulas. Flow controlled ventilation is a new ventilation modality capable for ventilation through a small diameter endotracheal tube (Tritube) with an active expiratory phase and the possibility of controlled carbon dioxide elimination during mechanical ventilation. The aim of the present trial is to characterize perioperative changes in lung volume, ventilation inhomogeneity and respiratory mechanics in patients undergo upper airway surgery under general anesthesia with either flow controlled or high-frequency jet ventilation.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Geneva University Hospitals | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva |
Switzerland,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in mean blood pressure | mean blood pressure (mmHg) | Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation | |
Other | Changes in heart rate | heart rate (beat per minute) | Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation | |
Other | Changes in oxygen saturation | Oxygen saturation will be measured by pulse oximetry (%) | Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation | |
Other | Changes in transcutaneous carbon dioxide | Transcutaneous carbon dioxide will be measured | Intraoperative period with specific time points: before anesthesia induction, at the beginning of the surgery, at the end of surgery, right after extubation | |
Primary | Alterations in the functional residual capacity (FRC) | FRC measured by the nitrogen multiple breath washout technique that will be applied before and after general anesthesia | Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit | |
Secondary | Alterations in the Lung clearance index (LCI) | LCI measured by the nitrogen multiple breath washout technique that will be applied before and after general anesthesia | Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit | |
Secondary | Alterations in the respiratory resistance assessed by the forced oscillation technique (FOT) | Respiratory mechanics will be measured by the forced oscillation technique (FOT) to evaluate respiratory resistance (R). | Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit | |
Secondary | Alterations in the respiratory reactance assessed by the forced oscillation technique (FOT) | Respiratory mechanics will be measured by the forced oscillation technique (FOT) to evaluate respiratory reactance (X). | Right before general anesthesia and approximately 1 hour after general anesthesia or before discharge from post anesthesia care unit |
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