respiratory failure weaning from mechanical ventilation training disconnection from the ventilator
Conditions
Interventions
Upon signing informed consent, patients will be randomized (1:1) in one of the
2 study arms, in order to eliminate any subjective clinical judgement whether a
patient is likely to benefit from HFTO
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >=18 years • Scheduled to wean from mechanical ventilation with tracheostomy
Exclusion criteria
Exclusion criteria: • Longstanding tracheostomy, defined as tracheostomy being present prior to current hospital admission • Tracheostomy primarily indicated for chronic upper airway obstruction or to secure airway patency due to persistent stupor/coma • Chronic positive pressure respiratory support at home (excluding night-time continuous positive airway pressure for sleep apnea) • Mucociliary disease in medical history (e.g. cystic fibrosis, pulmonary ciliary dyskinesia) • Neuromuscular disease in medical history (excluding ICU-acquired weakness) • Contra-indication placement oesophageal balloon for measurement of PES: o Fractures in mandibular, orbital or ethmoid bone or skull base o Esophageal varices or surgery in medical history o Severe bleeding disorders • Hemoptysis in 72 hours prior to the first disconnection session. Clinically relevant hemoptysis is defined as hemoptysis requiring tracheal/endobronchial or radiologic intervention, or administration of pro-coagulating drugs such as tranexamic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point is the difference between HME and HFTO in change in sputum viscoelasticity from baseline to the end of the long disconnection sessions (>=12 hours). Viscoelastic (G*) is made up of elasticity (G*) and viscosity (G**) of mucus at a 5% strain rate (or linear viscoelastic region, which reflects the small deformation regime) and the critical stress (* critical)· and strain (y critical) of mucus, which reflect the behavior of mucus under high amounts of shear stress and thus the large deformation regime. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference between HME and HFTO in change in sputum viscoelasticity from baseline to the end (after 10-90 min) of the early disconnection session 2. The difference in respiratory effort between HME and HFTO during early disconnection sessions measured by median PES-swing during the early disconnection session. 3. The difference in frequency of presence of self-reported dyspnea sensation and discomfort between HME and HFTO during early and late disconnection sessions. Presence of self-reported dyspnea is evaluated by asking patients as described in section 8.3. 4. The difference in severity of self-reported dyspnea sensation between HME and HFTO during early and late disconnection. Severity of self-reported dyspnea and discomfort is evaluated using a dyspnea visual-analog scale (D-VAS) as described in section 8.3. | — |
Countries
Netherlands
Contacts
Public ContactH. Endeman
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed