Dexmedetomidine versus current clinical practice for non-invasive mechanical ventilation: a randomized clinical trial

Phase 1

• Conditions: Accute respiratory insuffienciency; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-000497-38-ES
• Lead Sponsor: Ana Vallejo De la Cueva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-23
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 198

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<7,35 and/or
Pa02/Fi02 between 300 and 150.
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified