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Physiological consequences of expiratory muscle stimulation on the lung

Physiological consequences of expiratory muscle stimulation on the lung - Physiological consequences of expiratory muscle stimulation on the lung

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58098
Enrollment
15
Registered
2025-07-31
Start date
2025-11-01
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

Respiratory failure, acute respiratory failure breathing problems

Interventions

We will change the modality of ventilation from volume-controlled to pressure-controlled or vice versa, making sure that the level of inspiratory support (above PEEP) will be titrated to target the sa

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age above 18 yearsUse of the VentFree device for clinical reasonsA PaO2/FiO2 between 100-300 mmHgMechanically ventilated in controlled modeDeep sedation, defined by a Richmond Agitation-Sedation Scale (RASS) score of -5 or -4

Exclusion criteria

Exclusion criteria: Pre-existing neuromuscular diseaseMuscle paralysisPneumothoraxContra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement);Contra-indications for oesophageal balloon catheter placement (e.g. history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage or known/suspected varices);

Design outcomes

Primary

MeasureTime frame
The change in end-inspiratory transpulmonary pressure with or without expiratory muscle stimulation during volume-controlled ventilation and pressure-controlled ventilation.

Secondary

MeasureTime frame
- To investigate the impact of abdominal FES on end-expiratory, driving and elastancederived end-inspiratory transpulmonary pressure. - To investigate the impact of abdominal FES on mechanical power. - To investigate the impact of abdominal FES on the distribution of ventilation, lung collapse, overdistention and tidal recruitment, as measured by EIT. - To investigate the impact of abdominal FES on expiratory flow and flow limitation. - To investigate the effects of expiratory diaphragm activity. - To investigate whether expiratory diaphragm contractions modulate lung mechanics, including end-expiratory lung volume and expiratory flow. - To investigate changes in inspiratory effort in response to active expiration. - To investigate the extent to which abdominal FES influences the occurrence and magnitude of the Pendelluft phenomenon. - To investigate whether abdominal FES supports lung-protective ventilation strategies, for example reducing driving pressure or improving respiratory system compliance. - To investigate the effects of abdominal FES on gas exchange parameters.

Countries

Netherlands

Contacts

Public ContactEM Leijer

Radboud Universitair Medisch Centrum

esther.deleijer@radboudumc.nl0243619040

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)