Accute respiratory insuffienciency
Conditions
Interventions
Trade Name: DEXDOR
Pharmaceutical Form: Solution for infusion
Trade Name: PROPOFOL
MIDAZOLAM
MORPHINE
PHENTANYL
Pharmaceutical Form: Solution for infusion
Sponsors
Ana Vallejo De la Cueva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (over 18 years) - Reversible ARF secondary to cardiac failure, COPD exacerbation, pneumonia, post-extubation failure, fulfilling criteria for NIMV. >Respiratory distress signs or symptoms: Mild to severe dyspnea and/or Respiratory rate over 25 in COPD patients, over 30 in hypoxic patients and/or Accessory muscles use and/or paradoxical breathing. Hypercapnic encephalopathy >Gas exchange disturbances PaC02>45mmHg, pH=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: - CPR, need of intubation and mechanical ventilation. - Severe comorbidity ( myocardial ischemia, hypotension, arrhythmias) - Chronic obstruction of superior airway. - Tracheostomy. - Non-drained Neumothorax . - Severe agitation after drug administration. - Burns or facial trauma. - Facial surgery or facial abnormalities. - Hypersensibility or allergy to any drug in the study. - Egg, soya bean or peanut allergy. - HR less than 50 bpm non ?-blocker induced. - 2nd or 3rd grade AVB without pacemaker. - Cerebro-vascular severe injury. - Intracranial hypertension. - Glaucoma. - Miastenia gravis. - Concomitant use of inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir). - Pregnant women or breast-feeding period. - Refusal to enter the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analyze percentage of patients on dexmedetomidine for NIMV needing intubation compared to percentage of patients ongoing current clinical practice (CCP) needing intubation.;Secondary Objective: - Length (in hours) of NIMV for both groups. - ICU length of stay (in days) for both groups. - Hospital length of stay (in days) for both groups. - To compare global ICU mortality in both groups. - To compare respiratory failure related ICU mortality. - To analyze Global inhospital mortality. - To analyze Respiratory failure related inhospital mortality. - To describe ARF evolution in both groups. - To describe tolerance to NIMV along dexmedetomidine VS CCP administration. - To describe adverse effects related to dexmedetomidine administration. - Satisfaction survey for dexmedetomidine VS CCP.;Primary end point(s): Need of intubation: presence or any of these items. - Sp02 800 mmHg after vasoactive drugs. - Ischemic changes or ventricular arrhythmias on EKG related to myocardial hypoxia.;Timepoint(s) of evaluation of this end point: End of NIMV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Duration of NIMV (in hours). ? ICU stay (days). ? Hospital stay (days). ? Global ICU mortality. ? Specific ICU mortality. ? Global inhospital mortality. ? Respiratory failure related inhospital mortality. ? ARF evolution in both groups. ? Tolerance to NIMV ? Adverse effect. ? Satisfaction survey.;Timepoint(s) of evaluation of this end point: End of NIMV or ICU stay or Hospital stay | — |
Countries
Spain
Contacts
Public ContactAna Vallejo
Araba University Hospital
Outcome results
None listed