This study compare the effectiveness of dexmedetomidine as a sedative drug during NIV and the different strategies routinely used in patients with ARF of different aetiologies. Efficacy will be assessed based on absence of intubation, short term prognosis, and occurrence of medical complications.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Araba University Hospital
Vitoria-Gasteiz, Álava, Spain
To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial.
Need for intubation is defined as the presence of any of the following: SpO2\<80% or P aO2/FiO2\<150, seizures, poor secretion management, hypercapnia and pH\<7.20, hypotension: systolic blood pressure (SBP)\<80 mmHg refractory despite administration of vasoactive amines or electrocardiogram (ECG) with ischaemic changes or ventricular arrhythmia resulting from myocardial hypoxia.
Time frame: 72 hours
To determinate NIV duration of NIV in each group.
Number of hours the patient will be on NIV.
Time frame: 72 hours
To analyse stay at the ICU in each group.
Number of days patients stay at the ICU until they are discharged home or die.
Time frame: An average of 5 days
To analyse hospital stay in each group
Number of days patients remain at the hospital until they are discharged home or die.
Time frame: 15 days
To compare all-cause mortality at the ICU in both groups.
Percentage of all deaths from any cause in patients with ARF on NIV at the ICU in both study groups.
Time frame: Through study completion, an average of 3 years
To compare specific mortality at the ICU in both groups.
Percentage of deaths attributable to ARF in patients on NIV at the ICU in both study groups.
Time frame: Through study completion, an average of 3 years
To analyse hospital-specific mortality.
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Percentage of all deaths attributable to ARF in patients on NIV at the ICU discharged to a ward in the 2 study groups.
Time frame: Through study completion, an average of 3 years
To analyse all-cause hospital mortality.
Percentage of all deaths from any aetiology of ARF in patients treated with NIV in the ICU discharged to a ward in the 2 study groups.
Time frame: Through study completion, an average of 3 years
To report the course of ARF in each group.
Based on the presence before the start of NIV
Time frame: 1 and 24 hours after NIV
To report NIV tolerance during administration of dexmedetomidine versus SCP.
Nausea and/or vomiting, Aspiration pneumonia, delirium, agitation, interface tolerance or pain secondary to use of interface.
Time frame: During administration of dexmedetomidine/SCP and up to 24 hours after drug infusion/SCP is completed.
To report the adverse effects of dexmedetomidine.
Bradycardia, hypotension, tachycardia, hypertension and/or transient respiratory depression.
Time frame: During drug administration and up to 24 hours after drug infusion is completed.
To asses patient satisfaction with dexmedetomidine as compared to SCP
Patient satisfaction with use of dexmedetomidine as compared to drugs used in SCP will be estimated once NIV and dexmedetomidine/SCP infusion have been completed, using a Likert type questionnaire.
Time frame: Through study completion, an average of 3 years