Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563544
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
FCV Vs VCV in Obstructive and Asthmatic Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Flow Versus Volume-Controlled Ventilation in Intubated Obstructive and Asthmatic Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this physiological pilot study with a randomized crossover design is to study the effect of Flow-controlled ventilation FCV on the minute volume compared to Volume-controlled ventilation VCV in intubated patients with an exacerbation of their asthma or COPD
Our hypothesis is that FCV will results in a lower minute volume compared to VCV in this patient category
Patients will be randomized between two ventilation sequences namely 90 minutes of FCV followed by 90 minutes of VCV or vice versa
Our hypothesis is that FCV will results in a lower minute volume compared to VCV in this patient category
Patients will be randomized between two ventilation sequences namely 90 minutes of FCV followed by 90 minutes of VCV or vice versa
Detailed Description:
Rationale Patients with an exacerbation of asthma or chronic obstructive pulmonary disease COPD requiring controlled mechanical ventilation CMV on the intensive care unit ICU have a mortality rate between 10 and 20 This mortality rate is largely explained by major complications associated with mechanical ventilation eg pneumothorax cardiovascular collapse and pneumonia Complications are the result of dynamic hyperinflation that forms the cornerstone in the pathophysiology of both diseases The diameter of the smaller airways decreases because of inflammation bronchospasm mucus asthma and the loss of elastic recoil by emphysema COPD This leads in particular to a high airway resistance during expiration and the residue of tidal volume in the lung when the next inspiration begins The result is dynamic hyperinflation with a continuously increasing lung volume with high pressures pneumothorax barotrauma and hemodynamic collapse as a result During CMV pressure- or volume controlled ventilation PCV or VCV only the inspiration is controlled while expiration is passive possibly leading to airway collapse and further dynamic hyperinflation Besides both ventilation modes are accompanied by high flow rates leading to a further increase in airway resistance and ventilation pressures Flow controlled ventilation FCV is a mechanical ventilation method that uses a relatively low and constant flow during both inspiration and expiration thereby decreasing airway resistance and preventing airway collapse during expiration Besides FCV has shown to have a higher ventilation efficiency measured by a decrease in minute volume at stable arterial partial pressures of carbon dioxide PaCO2 This makes FCV a very interesting ventilation mode in intubated patients with an exacerbation of asthma or COPD possibly decreasing the amount of dynamic hyperinflation and complications in these patients Although FCV is widely used for hypoxic respiratory failure on the ICU so far no studies have been performed in asthma or COPD patients
We hypothesize that FCV in intubated patients with an exacerbation of asthma or COPD results in a lower minute volume MV and decreased end-inspiratory lung volume EILV as a measurement for dynamic hyperinflation compared to VCV
Objectives To study the effect of FCV on the MV and EILV compared to VCV
Study design Physiological pilot study with a randomized crossover design comparing FCV and VCV
Study population Patients with an asthmaCOPD exacerbation 18 years old receiving CMV
Intervention Patients are mechanically ventilated with VCV at baseline Upon inclusion the EIT-belt and an esophageal balloon are placed to assess the EILV and transpulmonary pressures respectively Besides patients are randomized between the sequence of ventilation mode namely 90 minutes of VCV followed by 90 minutes of FCV or 90 minutes of FCV followed by 90 minutes of VCV When VCV is switched to FCV the same mechanical ventilator settings are used as in the VCV mode After half an hour on FCV the PEEP drivingpressure and flow of FCV are optimized based on the highest compliance and lowest flow matching with a stable PaCO2 VCV is always set according to standard of care Total time of measurements study time is 180 minutes
Main study parametersendpoints Primary endpoint is the difference in minute volume after 90 minutes on FCV compared to after 90 minutes of VCV An important secondary endpoint is the difference in EILV after 30 minutes on FCV compared to after 30 minutes of VCV
Nature and extent of the burden and risks associated with participation benefit and group relatedness All patients are sedated and on CMV therefore there will be no discomfort for the patient FCV has been successfully applied during surgery and on the ICU and the patient will be monitored continuously so the clinical team can act directly in case of any adverse event Lung volume is measured with EIT a non-invasive radiation-free monitoring tool Transpulmonary pressures are measured with an esophageal balloon that is placed in a similar manor as a nasogastric feeding tube Therefore overall the risks of this study are limited
We hypothesize that FCV in intubated patients with an exacerbation of asthma or COPD results in a lower minute volume MV and decreased end-inspiratory lung volume EILV as a measurement for dynamic hyperinflation compared to VCV
Objectives To study the effect of FCV on the MV and EILV compared to VCV
Study design Physiological pilot study with a randomized crossover design comparing FCV and VCV
Study population Patients with an asthmaCOPD exacerbation 18 years old receiving CMV
Intervention Patients are mechanically ventilated with VCV at baseline Upon inclusion the EIT-belt and an esophageal balloon are placed to assess the EILV and transpulmonary pressures respectively Besides patients are randomized between the sequence of ventilation mode namely 90 minutes of VCV followed by 90 minutes of FCV or 90 minutes of FCV followed by 90 minutes of VCV When VCV is switched to FCV the same mechanical ventilator settings are used as in the VCV mode After half an hour on FCV the PEEP drivingpressure and flow of FCV are optimized based on the highest compliance and lowest flow matching with a stable PaCO2 VCV is always set according to standard of care Total time of measurements study time is 180 minutes
Main study parametersendpoints Primary endpoint is the difference in minute volume after 90 minutes on FCV compared to after 90 minutes of VCV An important secondary endpoint is the difference in EILV after 30 minutes on FCV compared to after 30 minutes of VCV
Nature and extent of the burden and risks associated with participation benefit and group relatedness All patients are sedated and on CMV therefore there will be no discomfort for the patient FCV has been successfully applied during surgery and on the ICU and the patient will be monitored continuously so the clinical team can act directly in case of any adverse event Lung volume is measured with EIT a non-invasive radiation-free monitoring tool Transpulmonary pressures are measured with an esophageal balloon that is placed in a similar manor as a nasogastric feeding tube Therefore overall the risks of this study are limited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None