Acute Respiratory Failure (ARF) or with a difficult weaning in patients ventilated MedDRA version: 9.1 Level: LLT Classification code 10001053 MedDRA version: 9.1 Level: LLT Classification code 10003541 MedDRA version: 9.1 Level: LLT Classification code 10049683
Conditions
Interventions
Trade Name: ULTIVA*IV 5FL 1MG
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Remifentanil
Concentration unit: µg/kg microgram(s)/kilogram
Concentration type: equal
Concent
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients admitted in Intensive Care Unit with ARF or a difficult weaning agitated or poorly cooperating informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: age85 years; gastro-esophageal diseases or surgery in the previous 3 months; hemodynamic instability despite adequate filling (i.e. need for continous infusion of epinephrine or vasopressin or dopamine or norepinephrine).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of different doses of remifentanil in patients ventilated in two different modes of ventilatory support: Pressure Support Ventilation (PSV), the gold standard and Neurally Adjusted Ventilatory Assist (NAVA), a new mode wherein the assistance is provided in proportion to diaphragm electrical activity (Eadi).;Secondary Objective: n.d.;Primary end point(s): The end point of the study is to improve patient-ventilator interaction among patients with Acute Respiratory Failure (ARF) or with a difficult weaning and the tolerance to the mechanical ventilation. | — |
Countries
Italy
Outcome results
None listed