💬In plain words
What the trial is, and whether it could suit you
Acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) are a major source of morbidity and mortality for patients and cost to the society. In case of acute respiratory failure with hypercapnia and acidosis, Non Invasive Ventilation (NIV) is preferred as a first line treatment.
NIV failures are not uncommon, from 15% in intensive care to 25 - 30% in emergency departments. They most often occur at the start of the NIV or in the hours that follow. There are many reasons for these failure. Among these are; dyspnea, discomfort, the pain related to the exacerbation and also to the NIV are frequently noted.
The use of certain drugs with anxiolytic, hypnotic and/or analgesic properties could also be useful. Some sedatives and opioids have already been studied in this indication but without a therapeutic trial and satisfactory methodology. Among the molecules of interest, Morphine
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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