Comparison between controlled flow ventilation and jet ventilation in patients undergoing ENT surgery under general anesthesia.

Switzerland (ICTRP)

ICTRP Studien-ID
NCT06063798 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Comparison of Flow-Controlled Ventilation with EVONE Tritube and High frequency Jet Ventilation in Patients undergoing Laryngotracheal Surgery (BASEC)

Wissenschaftlicher Titel
Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery (ICTRP)

Öffentlicher Titel
Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery (ICTRP)

Untersuchte Krankheit(en)
Ventilation;Lung Function;Anesthesia, General (ICTRP)

Untersuchte Intervention
Other: General anesthesia for laryngotracheal surgery;Other: Mechanical ventilation by FCV;Other: Mechanical ventilation by HFJV (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor). (ICTRP)

Ein-/Ausschlusskriterien
Gender: All
Maximum age: 100 Years
Minimum age: 18 Years

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
(ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Alterations in the functional residual capacity (FRC) (ICTRP)

Alterations in the Lung clearance index (LCI);Alterations in the respiratory resistance assessed by the forced oscillation technique (FOT);Alterations in the respiratory reactance assessed by the forced oscillation technique (FOT) (ICTRP)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Gergely Albu, MD, PhD;Gergely Albu, MD, PhD;Gergely Albu, MD, PhD, gergely.albu@hcuge.ch, 0041795532052;0041795532052, University Hospital, Geneva, (ICTRP)

Sekundäre IDs
SNCTP000005183, BASEC2022-D0078 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06063798 (ICTRP)