Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT04358133
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04358133
Study Brief:
Protocol Section:
NCT04358133