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Reducing shortness of breath symptoms through the use of brain-controlled ventilation via a mask in patients experiencing a lung attack due to chronic bronchitis

Effect of Non-Invasive Ventilation with Neurally Adjusted Ventilatory Assiston dyspnea in Acute Exacerbations of COPD - Effect of Non-Invasive Ventilation with Neurally Adjusted Ventilatory Assiston dyspnea in Acute Exacerbations of COPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58177
Enrollment
20
Registered
2025-08-07
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic lung disease

Interventions

In this study, the included patients will receive a NAVA catheter in order to be able to measure the electrical activity of the diaphragm (Edi). Placement of a nasogastric tube is considered standard
1) PS-NIV with 5 cm H2O support, 2) NAVA-NIV with 5 cm H2O support, 3) PS-NIV with 10 cm H2O support and 4) NAVA-NIV with 10 cm H2O support. This study design has been summarized in figure 1. During t

Sponsors

Bravis Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patient COPD confirmed by spirometry Admission to the ICU department with AECOPD resulting in respiratory failure

Exclusion criteria

Exclusion criteria: Need for intubation Non-cooperative or patient with reduced consciousness (GCS <13) Neuromuscular disorders affecting diaphragmatic function (e.g. myasthenia gravis or ALS). Known diaphragmatic hernia or esophageal malformation Severe facial deformities preventing proper mask fitting for non-invasive ventilation. Contra-indications to nasogastric tube placement

Design outcomes

Primary

MeasureTime frame
Dyspnea; measured in Multidimensional Dyspnea Profile (MDP).

Secondary

MeasureTime frame
Difference in airway occlusion pressure at equal mean airway pressure in NAVA-NIV and PS-NIV as a marker of neuromuscular efficiency. End-tidal CO2 during NAVA-NIV and PS-NIV. Blood gas analysis. Patient preference for NAVA or PS – NIV. ICU length of stay Deterioration of AECOPD resulting in need for invasive ventilation. Reference outcomes of dyspnea scores in other AECOPD patients.

Countries

Netherlands

Contacts

Public ContactD Ghantous

Bravis Ziekenhuis

m.schluep@bravis.nl0887067706

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)