Last updated: November 30, 2023
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Lung Injury
Respiratory Failure
Acute Respiratory Distress Syndrome (Ards)
Treatment
Flow-controlled ventilation
Clinical Study ID
NCT06051188
ABR NL83234.078.23
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years or older
- Provided written informed consent
- Undergoing controlled mechanical ventilation via an endotracheal tube
- Meeting all criteria of the Berlin definition of ARDS
- Hypoxic respiratory failure within 1 week of a known clinical insult or new orworsening respiratory symptoms
- Bilateral opacities on X-ray or CT-scan not fully explained by effusions,lobar/lung collapse (atelectasis), or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload.
- Oxygenation: moderate ARDS P/F ratio between 101-200 mmHg, severe ARDS PF ratio ≤ 100mmHg, both with PEEP ≥ 5 cmH2O.
- Intubated ≤72 hours
Exclusion
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 notresponding 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
- Intubated > 72 hours
- 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.:
- Have a thorax circumference inappropriate for EIT-belt
- Thoracic wounds, bandages or deformities preventing adequate fit of EIT-belt
- Recent (<7 days) pulmonary surgery including pneumonectomy, lobectomy or lungtransplantation
- ICD device present (potential interference with proper functioning of the EITdevice and ICD device)
- Excessive subcutaneous emphysema
- Contra-indications for nasogastric tube or inability to perform adequatetranspulmonary pressure measurements with, e.g.:
- Recent esophageal surgery
- Prior esophagectomy
- Known presence of esophageal varices
- Severe bleeding disorders
Study Design
Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Flow-controlled ventilation
Phase:
Study Start date:
September 12, 2023
Estimated Completion Date:
May 31, 2026
Study Description
Connect with a study center
Maasstad Hospital
Rotterdam, Zuid-Holland 3079DZ
NetherlandsActive - Recruiting
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