Respiratory
Conditions
Interventions
NIV only
Sponsors
Farhat Hached university hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Consecutive adult patients (=18 years) with chronic obstructive pulmonary disease (COPD) admitted to the intensive care unit for an acute exacerbation will be included. Eligibility requires : meeting the GOLD criteria for COPD, having a pH <7.35, and being assessed as suitable for NIV by the attending physician.
Exclusion criteria
Exclusion criteria: - Patients unable to tolerate NIV or for whom NIV is contraindicated - Patients with severe hearing impairment or deafness - Patients for whom life-sustaining therapies have been withdrawn - Patients who have received antidepressant or antipsychotic medications in the previous two months - Aversion of music as assessed by personal interview
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be the efficacy of NIV measured by the reduction in PCO2. This will be calculated as the difference between baseline PCO2 and the PCO2 levels recorded at specific time points during the non-invasive ventilation (NIV) session (h2, h4): ?PCO2=Baseline PCO2 (t0) -Endpoint PCO2 (t1, t2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: • Unplanned interventions: The number of unplanned interventions required by caregivers during the NIV session will be documented. • Changes in respiratory and cardiovascular parameters: These parameters will be assessed before the NIV session, immediately after proper setup (5 minutes), and then at hourly intervals (h1, h2, h3, h4): - Respiratory rate (RR) - Peripheral oxygen saturation (SpO2) - Tidal volume (Vt) - Leak rate - Heart rate (HR) - Systolic blood pressure (SBP) - Diastolic blood pressure (DBP) • Respiratory comfort: assessed using a digital visual scale, changes in respiratory comfort will be measured (h0, h2, h4). • Neurological assessment (h0, h2, h4): - Encephalopathy score (Kelly-Matthay scale) - Glasgow Coma Scale - Richmond Agitation-Sedation Scale (RASS) • Patient-reported outcomes (h0, h2, h4): - Borg Dyspnea Scale (BDS) - Verbal Numeric Rating Scale (VNS) for pain assessment • Psychological assessment (h0, h4): - Rapid Clinical Test For delirium (4 AT) - State Trait Anxiety Inventory (STAI) - Spielberger’s trait anxiety inventory - Perceived stress scale (PSS) | — |
Countries
Tunisia
Contacts
Public ContactImen Ben Saida
Professeur
Outcome results
None listed