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Flow versus Volume Controlled Ventilation in intubated obstructive and asthmatic patients

Flow versus Volume Controlled Ventilation in intubated obstructive and asthmatic patients - FCV vs VCV in obstructive and asthmatic patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56884
Enrollment
10
Registered
2024-07-11
Start date
2025-01-17
Completion date
Unknown
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma/COPD and obstructive pulmonary dissease Asthma/COPD and obstructive pulmonary dissease

Interventions

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, pat

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 (

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the difference in minute volume after 90 minutes on FCV compared to after 90 minutes of VCV.

Secondary

MeasureTime frame
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)

Countries

Netherlands

Contacts

Public ContactJ. Oosten

Erasmus MC, Universitair Medisch Centrum Rotterdam

researchICV@erasmusmc.nl010-703 5142

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)