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Completed
NCT05668299
Determining the Appropriate Setting of an Automated Secretion Removal Technology (TrachFlush)
Conditions: Mechanical Ventilation Complication, Intubation Complication
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: Hospitalsenheden Vest
Location: Denmark
Summary
Using a new device, the TrachFlush, the aim of this pilot study is to investigate whether secretions can be removed at the patient's current ventilator settings, or whether pressures and durations considered at the maximal end of clinical practice are required, so as to push secretions around the cuff.
The study is a pilot study to investigate the settings required to ensure clinical efficacy of the technology, prior to large scale clinical studies.
Eligibility Criteria
Inclusion Criteria:Orally intubated and mechanically ventilatedPatients for whom it is expected that secretions will be present during their ventilation period, as assessed by clinical evaluation.Exclusion Criteria:Admission due to tracheal damage, e.g.
inhalation trauma.Severe ARDS (acute respiratory distress syndrome), indicated by a PaO2/FiO2 ratio lower than 100 mmHg or PEEP > 15 cmH2O.Circulatory instability indicated by use of vasopressor (Norepinephrine) >0.1 micro gm/kg/min, heart rate >120, arrhythmia other than atrial fibrillation.Patients with agitated delirium.Mechanical ventilation via tracheostomyMechanical ventilation is provided with a mask or other non-invasive meansPregnancy
Source: ClinicalTrials.gov (NCT05668299). StuddyBuddy aggregates publicly available trial information.