Flow versus Volume Controlled Ventilation in intubated obstructive and asthmatic patients

• Conditions: Asthma/COPD and obstructive pulmonary dissease; 10006436

• Registration Number: NL-OMON56884
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the difference in minute volume after 90 minutes on FCV<br /><br>compared to after 90 minutes of VCV. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>These following secondary study parameters will be measured at baseline (VCV)<br /><br>and thereafter every 30 minutes on FCV and VCV for a total of 180 minutes:<br /><br>- Dynamic hyperinflation (EILV; End-Inspiratory Lung Volume)<br /><br>- Vei (volume end-inspiration; estimated by formula: Vei = ((tidal volume x<br /><br>Pplateau)/(Plateau - PEEPtotal))<br /><br>- Mechanical Power (Joules per minute)<br /><br>- Dissipated energy (Joules per tidal volume)<br /><br>- Airway pressures (peak airway pressure, plateau pressure, mean airway<br /><br>pressure, PEEP, intrinsic PEEP, driving pressure)<br /><br>- Transpulmonary pressures (end-expiratory transpulmonary pressure,<br /><br>end-inspiratory transpulmonary pressure, transpulmonary driving pressure)<br /><br>- Regional Ventilatory Delay Index (RVDI)<br /><br>- Global Inhomogenity Index (GI)<br /><br>- Gas exchange (ventilatory ratio, arterial blood gas measurements)<br /><br>- Hemodynamic parameters (e.g. mean arterial pressure, heart rate)</p><br>