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

Switzerland (ICTRP)

ID di studio ICTRP
NCT06063798 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Comparison of Flow-Controlled Ventilation with EVONE Tritube and High frequency Jet Ventilation in Patients undergoing Laryngotracheal Surgery (BASEC)

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

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

Malattie studiate
Ventilation;Lung Function;Anesthesia, General (ICTRP)

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

Tipo di studio
Interventional (ICTRP)

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

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

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

ID secondari
SNCTP000005183, BASEC2022-D0078 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06063798 (ICTRP)