Status:
COMPLETED
Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many similarities...
Detailed Description
Randomized, double-blind, placebo-controlled, parallel-group, single-center phase 2 pilot study.The experimental group will receive an intravenous titration of morphine followed by a subcutaneous admi...
Eligibility Criteria
Inclusion
- Adult patients ≤ 75 years
- Admitted in intensive care for an acute respiratory failure defined as a respiratory rate\> 24 / min or signs of respiratory distress such as labored breathing or paradoxical inspiration, or SpO2 \<90% in ambient air
- Spontaneous ventilation, either under standard oxygen, high flow oxygen or non invasive ventilation
- Dyspnea ≥ 40 on an dyspnea-VAS from zero (no dyspnea) to 100 (worst possible dyspnea)
- Richmond agitation and sedation scale (RASS) between 0 and 2.
- No confusion, as defined by the CAM-ICU
- Signed informed consent
Exclusion
- Intubated patient
- Intubation planned upon admission
- Hearing or visual impairment
- Insufficient command of French
- Previous psychiatric or cognitive disorders known
- Moribund patient
- Known hypersensitivity to opioids
- Severe renal insufficiency (creatinine clearance \<30 ml / min)
- Severe hepatocellular insufficiency (factor V \<50%)
- Any formal contra-indication of opiates
- Opioid use within the 24 hours before inclusion
- Pregnancy or breastfeeding
- Minor and protected adult
- Exclusion period due to inclusion in another clinical trial
- Previous inclusion in this study
- No affiliation to social security
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04358133
Start Date
December 16 2020
End Date
October 7 2022
Last Update
October 25 2022
Active Locations (1)
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1
Groupe Hospitalier Pitié Salpetriere
Paris, France, 75013