FCV vs VCV in Obstructive and Asthmatic Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
FCV
Device90 minutes of FCV
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: FCV-VCVExperimental treatment 1 intervention
Group B: VCV-FCVExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MV
Minute Volume
Time frame
90 minutesSecondary outcomes
1
EILV
End-inspiratory lung volume
Time frame
90 minutes2
Vei
Volume end-inspiratory
Time frame
90 minutes3
MP
Mechanical Power (J/min)
Time frame
90 minutes4
Dissipated energy
Time frame
30 and 90 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Maasstad Hospital
Collaborator
Source ClinicalTrials.gov