Using Morphine to Improve Non-Invasive Ventilation Success in COPD Exacerbations
Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation (NIV) Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD), Phase I/IIa
This study is testing if giving morphine can help people with COPD breathe better during treatment with non-invasive ventilation when they have a flare-up.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble, Isère, Auvergne-Rhône-Alpes) |
| Trial ID | NCT04427826 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of morphine in reducing the failure rate of non-invasive ventilation (NIV) in patients experiencing acute exacerbations of chronic obstructive pulmonary disease (COPD). Patients aged 18 and older with a history of COPD will receive a single open-label injection of morphine at varying doses while undergoing NIV treatment. The study aims to determine the optimal morphine dose that balances efficacy and safety, using a Bayesian approach to refine dosing based on patient responses. The trial is conducted at the Emergency Department of Grenoble Alpes University Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of COPD who are experiencing an acute exacerbation requiring NIV treatment.
Not a fit: Patients who have already received NIV treatment prior to admission or those with contraindications to morphine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the management of acute COPD exacerbations, leading to better patient outcomes and reduced healthcare costs.
How similar studies have performed: While some studies have explored the use of sedatives and opioids in similar contexts, this specific approach with morphine is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients Aged ≥ 18 years * Current or former smoker at least 10 packs-years * Patient with a history of COPD according to the Gold guidelines , after review of the medical record by the physician in charge * Acute exacerbation of COPD (greater degradation of respiratory symptoms than the usual daily variations and requiring a modification of therapeutic management) * Need to implement NIV treatment (respiratory acidosis with pH\<7.35) * Ventilation frequency \> 20min * Affiliation to the French security system (or equivalent) * Written informed consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency inclusion procedure will be allowed, with a mandatory delayed consent. Exclusion Criteria: * Patient already treated by NIV during admission (e. g. introduction in pre-hospital by SMUR) or started more than one hour ago in the department. * Sedative (barbiturates, benzodiazepines and related substances and other sedatives) or morphine treatment within 24 hours before inclusion * Chronic alcoholism * Contra-indication to NIV: disturbances of consciousness (Glasgow \< 11) except moderate hypercapnic encephalopathy; indication of immediate intubation; risk of inhalation; sputum impossible; hemodynamic instability; inability to remove the mask; trauma, surgery or facial malformation; patients with pH \< 7.25 can only be included in intensive care unit or in the vital emergency room of the emergency department, under continuous monitoring * NIV with palliative purpose from the outset with death expected within 24 hours of inclusion * Non-communicative patient or significant dementia making them unable to participate in the study * Contra-indication to morphine without acute respiratory distress * Pregnant or breastfeeding women * Major mentioned in Articles L1121-6 and 1121-8 of French public health cod * Patients in a period of exclusion from other research involving the human person type 1 or 2 * Subject cannot be contacted in case of emergency
Where this trial is running
Grenoble, Isère, Auvergne-Rhône-Alpes
- Emergency Department of Grenoble Alpes University Hospital — Grenoble, Isère, Auvergne-Rhône-Alpes, France (Recruiting)
Study contacts
- Principal investigator: Damien VIGLINO, MD, PhD — Grenoble Alpes University Hospital, HP2 laboratory - INSERM U1042 and Grenoble Alpes University
- Study coordinator: Damien VIGLINO, MD, PhD
- Email: DViglino@chu-grenoble.fr
- Phone: 0033476766784
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.