Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06051188
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-09-07
Brief Title:
FCV vs PCV in Moderate to Severe ARDS
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Flow Versus Pressure Controlled Ventilation in Patients With Moderate to Severe Acute Respiratory Distress Syndrome
Status:
RECRUITING
Status Verified Date:
2023-11
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:
None
Brief Summary:
The goal of this clinical trial is to compare flow-controlled ventilation FCV and pressure-controlled ventilation PCV in patients with moderate to severe acute respiratory distress syndrome on the intensive care unit
The main questions it aims to answer are
Is the mechanical power during flow-controlled ventilation lower than during pressure-controlled ventilation
To gain more understanding about other physiological effects and potential benefits of flow-controlled ventilation in comparison to pressure-controlled ventilation oa the end-expiratory lung volume and homogeneity of ventilation
Participants will be randomized between two ventilation mode sequences being 90 minutes of FCV followed by 90 minutes of PCV or vice versa
The main questions it aims to answer are
Is the mechanical power during flow-controlled ventilation lower than during pressure-controlled ventilation
To gain more understanding about other physiological effects and potential benefits of flow-controlled ventilation in comparison to pressure-controlled ventilation oa the end-expiratory lung volume and homogeneity of ventilation
Participants will be randomized between two ventilation mode sequences being 90 minutes of FCV followed by 90 minutes of PCV or vice versa
Detailed Description:
Rationale During controlled mechanical ventilation CMV only the inspiration is controlled by either a set driving pressure Pressure Controlled Ventilation PCV or tidal volume Volume Controlled Ventilation VCV The expiration depends on the passive elastic recoil of the respiratory system and cannot be controlled and lasts until the airway pressure is equal to the positive end-expiratory pressure PEEP The exponential decrease in airway pressure during expiration may result in alveolar collapse and hypoxemia Flow controlled ventilation FCV is a mechanical ventilation method that uses a constant flow during both inspiration and expiration FCV results in a gradual decrease in airway pressure during expiration as flow is controlled In both animal and prospective crossover studies controlled expiration resulted in higher mean airway pressures with reduced alveolar collapse Besides FCV resulted in a higher ventilation efficiency measured by a decrease in minute volume at stable arterial partial pressures of carbon dioxide PaCO2 Where a reduction in alveolar collapse may lead to less atelectrauma a higher ventilation efficiency may lead to a lower mechanical power MP which is the amount of energy Joules that is transferred to the respiratory system by the mechanical ventilator every minute Both are important determinants of Ventilator Induced Lung Injury VILI This makes FCV a very interesting ventilation mode in patients with the acute respiratory distress syndrome ARDS in which VILI is still a major contributor to overall morbidity and mortality Two prior prospective cross-over studies have been performed in COVID-19 ARDS patients that did show a lower minute volume with FCV compared to PCV or VCV However these studies did not take into account assessments of the MP or end-expiratory lung volume EELV which is a measurement of lung aeration
The investigators hypothesize that FCV in patients with moderate to severe ARDS results in a lower MP and an increased EELV compared to standard CMV modes PCV or VCV
Objectives To study the effect of FCV on the MP and the EELV compared to PCV
Study design Randomized crossover physiological pilot study comparing FCV and PCV
Study population Patients with moderate to severe ARDS 18 years old receiving CMV
Intervention Patients are mechanically ventilated with PCV mode at baseline Upon inclusion the EIT-belt and an esophageal balloon are placed to assess the EELV and transpulmonary pressures respectively Besides participants are randomized between the sequence of ventilation mode namely 90 minutes of PCV followed by 90 minutes of FCV or 90 minutes of FCV followed by 90 minutes of PCV When PCV is switched to FCV the same mechanical ventilator settings are used as in the PCV mode After half an hour on FCV the PEEP driving pressure and flow of FCV are optimized based on the highest compliance and lowest flow matching with a stable PaCO2 thereby not exceeding lung protective ventilation limits transpulmonary driving pressure 12cmH2O and tidal volumes 8 mlkg ideal body weight IBW PCV 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 MP after 90 minutes on FCV compared to after 90 minutes of PCV An important secondary endpoint is the difference in EELV after 30 minutes on FCV compared to after 30 minutes of PCV
Nature and extent of the burden and risks associated with participation benefit and group relatedness All participants 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 During optimization of FCV no lung protective ventilation limits will be exceeded Therefore overall the risks of this study are limited
The investigators hypothesize that FCV in patients with moderate to severe ARDS results in a lower MP and an increased EELV compared to standard CMV modes PCV or VCV
Objectives To study the effect of FCV on the MP and the EELV compared to PCV
Study design Randomized crossover physiological pilot study comparing FCV and PCV
Study population Patients with moderate to severe ARDS 18 years old receiving CMV
Intervention Patients are mechanically ventilated with PCV mode at baseline Upon inclusion the EIT-belt and an esophageal balloon are placed to assess the EELV and transpulmonary pressures respectively Besides participants are randomized between the sequence of ventilation mode namely 90 minutes of PCV followed by 90 minutes of FCV or 90 minutes of FCV followed by 90 minutes of PCV When PCV is switched to FCV the same mechanical ventilator settings are used as in the PCV mode After half an hour on FCV the PEEP driving pressure and flow of FCV are optimized based on the highest compliance and lowest flow matching with a stable PaCO2 thereby not exceeding lung protective ventilation limits transpulmonary driving pressure 12cmH2O and tidal volumes 8 mlkg ideal body weight IBW PCV 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 MP after 90 minutes on FCV compared to after 90 minutes of PCV An important secondary endpoint is the difference in EELV after 30 minutes on FCV compared to after 30 minutes of PCV
Nature and extent of the burden and risks associated with participation benefit and group relatedness All participants 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 During optimization of FCV no lung protective ventilation limits will be exceeded Therefore overall the risks of this study are limited
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