Using Morphine to Improve Non-Invasive Ventilation Success in COPD Exacerbations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.