Comparison between controlled flow ventilation and jet ventilation in patients undergoing ENT surgery under general anesthesia.
Résumé de l'étude
In the context of ENT surgeries under general anesthesia, there are several ways to ventilate patients, that is, to support the patient's breathing with a ventilator. In our study, we compare two different ventilators with different modes: controlled flow ventilation or high-frequency ventilation. In the medical literature, there are no clear data to show whether there is a better method than the other. The aim of our study is to compare the two methods already used and to understand which type of ventilation is best for the patient's respiratory capacity.
(BASEC)
Intervention étudiée
We evaluate the effects of mechanical ventilation with two different types of ventilators before and after general anesthesia.
(BASEC)
Maladie en cours d'investigation
Respiratory function before and after general anesthesia.
(BASEC)
General anesthesia for laryngotracheal surgery Adult patients, both female and male, over 18 years old Elective surgery (BASEC)
Critères d'exclusion
Documented severe heart diseases Documented severe respiratory diseases Documented severe neurological diseases (BASEC)
Lieu de l’étude
Genève
(BASEC)
Sponsor
Prof Benno Rehberg-Klug, Hôpitaux Universitaires de Genève
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Gergely Albu
0041795532052
gergely.albu@clutterhcuge.chHôpitaux Universitaires de Genève
(BASEC)
Informations générales
University Hospital, Geneva,
0041795532052;0041795532052
gergely.albu@clutterhcuge.ch(ICTRP)
Informations scientifiques
University Hospital, Geneva,
0041795532052;0041795532052
gergely.albu@clutterhcuge.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
24.10.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT06063798 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Comparison of Flow-Controlled Ventilation with EVONE Tritube and High frequency Jet Ventilation in Patients undergoing Laryngotracheal Surgery (BASEC)
Titre académique
Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery (ICTRP)
Titre public
Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery (ICTRP)
Maladie en cours d'investigation
Ventilation;Lung Function;Anesthesia, General (ICTRP)
Intervention étudiée
Other: General anesthesia for laryngotracheal surgery;Other: Mechanical ventilation by FCV;Other: Mechanical ventilation by HFJV (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Gergely Albu, MD, PhD;Gergely Albu, MD, PhD;Gergely Albu, MD, PhD, gergely.albu@hcuge.ch, 0041795532052;0041795532052, University Hospital, Geneva, (ICTRP)
ID secondaires
SNCTP000005183, BASEC2022-D0078 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06063798 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible