By using advanced respiratory monitoring, we will aim to gain more understanding about the physiological effects and potential benefits of FCV in comparison to VCV in patients with an exacerbation of their asthma or COPD. We hypothesize that FCV in…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the difference in minute volume after 90 minutes on FCV
compared to after 90 minutes of VCV.
Secondary outcome
These following secondary study parameters will be measured at baseline (VCV)
and thereafter every 30 minutes on FCV and VCV for a total of 180 minutes:
- Dynamic hyperinflation (EILV; End-Inspiratory Lung Volume)
- Vei (volume end-inspiration; estimated by formula: Vei = ((tidal volume x
Pplateau)/(Plateau - PEEPtotal))
- Mechanical Power (Joules per minute)
- Dissipated energy (Joules per tidal volume)
- Airway pressures (peak airway pressure, plateau pressure, mean airway
pressure, PEEP, intrinsic PEEP, driving pressure)
- Transpulmonary pressures (end-expiratory transpulmonary pressure,
end-inspiratory transpulmonary pressure, transpulmonary driving pressure)
- Regional Ventilatory Delay Index (RVDI)
- Global Inhomogenity Index (GI)
- Gas exchange (ventilatory ratio, arterial blood gas measurements)
- Hemodynamic parameters (e.g. mean arterial pressure, heart rate)
Background summary
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 e.g., 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.
Study objective
By using advanced respiratory monitoring, we will aim to gain more
understanding about the physiological effects and potential benefits of FCV in
comparison to VCV in patients with an exacerbation of their asthma or COPD. 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.
Insights from this study allow the optimization of personalized lung protective
mechanical ventilation.
Study design
Randomized crossover physiological study comparing FCV and VCV.
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.
Study burden and risks
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. Patients could benefit from FCV by its potential to lower the amount
of dynamic hyperinflation and thereby the risk of complications during
mechanical ventilation. Besides, by recruitment FCV is able to optimize gas
exchange, an effect that is expected to continue after the patient is switched
back to VCV. FCV can only be applied during controlled mechanical ventilation.
Therefore, this study cannot be perfomed in a different setting.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older;
- Provided written informed consent;
- Undergoing controlled mechanical ventilation via an endotracheal tube;
- Reason for intubation being exacerbation of asthma or COPD;
- Intubated <=72 hours
Exclusion criteria
- Severe sputum stasis or production requiring frequent bronchial suctioning
(more than 5 times per nurse shift)
- Untreated pneumothorax (i.e. no pleural drainage)
- Hemodynamic instability defined as a mean arterial pressure below 60mmHg not
responding to fluids and/or vasopressors or a noradrenalin dose >0.5mcrg/kg/min
- High (>15 mmHg) or instable (an increase in sedation or osmotherapy is
required) intracranial pressure
- An inner tube diameter of 6mm or less
- Anticipating withdrawal of life support and/or shift to palliation as the
goal of care
- Inability to perform adequate electrical impedance tomography (EIT)
measurements with, e.g.:
o Have a thorax circumference inappropriate for EIT-belt
o Thoracic wounds, bandages or deformities preventing adequate fit of EIT-belt
o Recent (<7 days) pulmonary surgery including pneumonectomy, lobectomy or lung
transplantation
o ICD device present (potential interference with proper functioning of the EIT
device and ICD device)
o Excessive subcutaneous emphysema
- Contra-indications for nasogastric tube or inability to perform adequate
transpulmonary pressure measurements with, e.g.:
o Recent esophageal surgery
o Prior esophagectomy
o Known presence of esophageal varices
o Severe bleeding disorders
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86078.078.24 |