Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This study is a randomized, controlled, assessor blind, monocentric study. A new ventilation mode, called Flow Controlled Ventilation (FCV), has been suggested to minimize the amount of dissipated energy in the lungs and potentially could be protective during mechanical ventilation. FCV is unique in creating a stable gas flow into and also out of the patient's lungs to generate inspiration and expiration respectively. The FCV ventilation mode by its design allows the use of an ultrathin endotracheal tube with an inflatable cuff to secure the airways for ventilation. Therefore FCV offers several new surgical options for the treatment during laryngeal and tracheal surgery where the standard approach is usually the use of high-frequency jet ventilation (HFJV). The limitations of HFJV are however the lack of airway protection, limited monitoring of the respiratory variables and potential carbon dioxide (CO2) accumulation. Participants for this study will be recruited at the University Hospitals of Geneva, scheduled for laryngotracheal surgery under general anesthesia. A total of 50 patients will be enrolled and randomly assigned into 2 groups: Group FCV (Flow controlled ventilation) and Group HFJV (high-frequency jet ventilation). Measurements of functional residual capacity (FRC) and lung clearance index (LCI) will be performed in patients with a nitrogen multiple breath washout method, before and approximately 1 hour after surgery. Similarly, respiratory system resistance (R) and respiratory reactance (X) will be measured at the same time by using the Forced Oscillation Technique. Relevance: There are no studies that addressed the value of flow controlled ventilation in terms of lung function parameters (FRC and LCI) and lung mechanics (R, X) in comparison to high-frequency jet ventilation in patients undergoing upper airway surgery. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06063798
Study type Interventional
Source University Hospital, Geneva
Contact Gergely Albu, MD, PhD
Phone 0041795532052
Email gergely.albu@hcuge.ch
Status Recruiting
Phase N/A
Start date September 5, 2023
Completion date December 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05035069 - Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR Phase 4
Completed NCT03861364 - Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose. Phase 4
Completed NCT02711280 - The Effect of Anesthetics on Oxidative Stress and Apoptosis Status in Children N/A
Completed NCT01199471 - Estimate the Behavior of Chinese Anesthesiologists Practicing General Anesthesia With Sevoflurane N/A
Completed NCT00917033 - Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy Phase 4
Completed NCT00391885 - Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy Phase 4
Completed NCT00552617 - A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971) Phase 2
Completed NCT03705026 - Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
Completed NCT00552929 - A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974) Phase 2
Completed NCT00475215 - Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017) Phase 3
Completed NCT00298831 - Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023) Phase 3
Recruiting NCT03943745 - EEG Changes During Induction of Propofol Anesthesia
Completed NCT03697642 - Nasopharyngeal Airway Guide Nasogastric Tube Placement N/A
Completed NCT04595591 - Observation of Propofol Titration at Different Speeds N/A
Not yet recruiting NCT05841316 - The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block
Completed NCT04532502 - Impact of Anesthetic Environment the Sex Ratio of the Children of Female Assistants
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT06205212 - High-flow Nasal Oxygenation During Preoxygenation and Atelectasis N/A
Completed NCT00379613 - Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942) Phase 2
Completed NCT03841890 - The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure N/A