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, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other populations. However, to date, data regarding the impact of morphine on dyspnea in intensive care unit patients admitted for acute respiratory failure are scarce. There may be a reluctance of physicians to prescribe opioids that is not scientifically justified. The study will focus on patient reported outcome (PRO) criteria. The ultimate goal of this pilot study is to design the protocol of a future pragmatic trial.
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 administration of morphine hydrochloride for 24 hours according to a predefined protocol. The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm Patients will be randomized 1:1 between low-dose titrated morphine (experimental group) and placebo (control group). The other treatments will be similar in both groups, according to the protocol and the recommendations. Severe dyspnea will be assessed for regularly Patients will be followed for 48 hours: 24-hour treatment duration, evaluation of primary endpoint for first 24 hours, collection of adverse events for 48 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol
The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm
Groupe Hospitalier Pitié Salpetriere
Paris, France
Average dyspnea over 24 hours
Dyspnea will be assessed by VAS-dyspnea (ranging from zero, no dyspnea to 100, worst possible dyspnea) patient reported outcome criteria (PRO).
Time frame: systematically evaluated every 4 hours over 24 hours and whenever necessary
Intensity of dyspnea
patient reported outcome measure (PRO) ; min=0;max=100(worse)
Time frame: every 4 hours over 24 hours
Incidence of severe dyspnea (dyspnea ≥40)
patient reported outcome measure (PRO) ; min=0;max=100(worse)
Time frame: within 24 hours
Anxiety
Patient reported outcome measure (PRO) ; min=0;max=100(worse)
Time frame: every 4 hours as well as over the first 24 hours
Incidence of moderate to severe anxiety
Incidence of moderate to severe anxiety (PRO) ; min=0;max=100(worse)
Time frame: every 4 hours over 24 hours
Intubation rate
Intubation rate
Time frame: within the first 48 hours
Vigilance level (Glasgow Coma Scale : impaired alertness defined by Glasgow Coma Scale ≤ 12)
Vigilance level ; GCS : min=3(worse) ;max=15
Time frame: every 4 hours as well as the first 48 hours
Incidence of coma
Incidence of coma
Time frame: within the first 48 hours
Incidence of delirium
Incidence of delirium
Time frame: within the first every 4 hours as well as over the first 48 hours
Respiratory rate
Respiratory rate
Time frame: every 4 hours as well as over the first 24 hours
Proportion of patients requiring the transition from one oxygenation technique to another
Proportion of patients requiring the transition from one oxygenation technique to another
Time frame: At the end of the study (12 months)
Intensity of pain
Patient reported outcome measure (PRO) ; min=0;max=100(worse)
Time frame: every 4 hours
Duration of night sleep the first night
Duration of night sleep the first night (number of hours)
Time frame: at the end of the first night
Quality of sleep the first night
Patient reported outcome measure (PRO); min=0;max=100(worse)
Time frame: at the end of the first night
Severity of dry eye
Patient reported outcome criteria (PRO); min=0;max=100(worse)
Time frame: in the first 24 hours
Severity of dry nose
Patient reported outcome criteria (PRO); min=0;max=100(worse)
Time frame: in the first 24 hours
Severity of feeling of gastric distension
Patient reported outcome criteria (PRO); min=0;max=100(worse)
Time frame: in the first 24 hours
Constipation
Constipation (PRO); min=0;max=100(worse)
Time frame: in the first 48 hours
Nausea
Patient reported outcome criteria (PRO) ;min=0;max=100(worse)
Time frame: in the first 48 hours
Nurses' adherence to the protocol
Nurses' adherence to the protocol (questionnaire)
Time frame: in the first 24 hours
Nurses' satisfaction with the protocol
Nurses' satisfaction with the protocol (questionnaire)
Time frame: in the first 24 hours
Number of non invasive ventilation sessions
Number of non invasive ventilation sessions
Time frame: in the first 24 hours
Total duration of non invasive ventilation
Total duration of non invasive ventilation (number of hours)
Time frame: in the first 24 hours
Tolerance of non invasive ventilation
Tolerance of non invasive ventilation (PRO) ;min=0;max=100(worse)
Time frame: in the first 24 hours
Duration of HFNCO (high-flow nasal canula oxygenation)
Duration of HFNCO (number of hours)
Time frame: in the first 24 hours
Tolerance of HFNCO(high-flow nasal canula oxygenation)
Tolerance of HFNCO : number of adverses events
Time frame: in the first 24 hours
Duration of standard oxygen
Duration of standard oxygen (number of hours)
Time frame: in the first 24 hours
Tolerance of standard oxygen
Tolerance of standard oxygen : number of adverses events
Time frame: in the first 24 hours
Any adverse or serious event occurring
Any adverse or serious event occurring
Time frame: within the first 48 hours
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