Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06063798
Status:
RECRUITING
Last Update Posted:
2023-10-03
First Post:
2023-09-18
Brief Title:
Respiratory Effects of Flow-Controlled Ventilation and Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Comparison of Flow-Controlled Ventilation With EVONE Tritube and High Frequency Jet Ventilation in Patients Undergoing Laryngotracheal Surgery
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Flowjet
Brief 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
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
Detailed 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SNCTP000005183 | REGISTRY | KOFAM | None |