Status:
RECRUITING
Efficacy of Morphine in Reducing the Rate of Early Non-Invasive Ventilation Failure in Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Phase I/IIa
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 hyperc...
Detailed Description
Patients included in this dose-finding study will be enrolled consecutively after consent and verification of the selection criteria, with a minimum of 24 hours after completion of previous patient fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04427826
Start Date
December 8 2020
End Date
January 1 2027
Last Update
November 29 2023
Active Locations (1)
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1
Emergency Department of Grenoble Alpes University Hospital
Grenoble, Isère, Auvergne-Rhône-Alpes, France, 38043