Efficacy and Safety of Dexmedetomidine During Non-Invasive Positive Pressure Ventilation
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the efficacy and safety of dexmedetomidine during
      Non-invasive positive pressure ventilation (NPPV) for patients with acute respiratory failure
      compared to standard analgesic/sedation practices
    

Detailed description: 
      Non-invasive positive-pressure ventilation (NPPV) is increasingly being used to manage
      patients with acute respiratory failure (ARF) in an effort to avoid the numerous negative
      sequelae associated with intubation and mechanical ventilation. In the USA, it is estimated
      that 20-30% of all patients placed on mechanical ventilation are treated with NPPV.
      Indications for NPPV include but are not limited to acute or acute-on-chronic hypercapnic
      respiratory failure, pulmonary edema, respiratory failure in immunocompromised patients or
      that due to chest wall deformity or neuromuscular disease. For NPPV to be successful, it is
      critical that the patient be cooperative and comfortable (i.e. no pain) as agitation and
      discomfort interfere with the success of NPPV.

      Despite the importance of patient comfort during NPPV, physicians infrequently use sedation
      or analgesic therapy during NPPV, primarily due to concerns about the respiratory depressant
      effects of most of the sedatives (e.g., benzodiazepines) and analgesics (e.g., opioids) that
      are currently available. In addition, neither the benzodiazepines nor opioids are easily
      titratable, can easily accumulate and can be associated with both the development of delirium
      and a withdrawal effect.

      Dexmedetomidine is an intravenous rapid-onset, short acting ά 2-receptor agonist that is
      approved for short-term sedation in post-operative and critically ill patients. It has been
      stated that this drug produces a state of "cooperative sedation" allowing the patient to
      interact with health care providers. Dexmedetomidine has been used for its ability to cause
      sympatholysis and, because of analgesic properties, to decrease the need for opioids.
      Potential advantages include its short half life and intravenous route of administration,
      permitting rapid titration to achieve sedation targets and, in patients with respiratory
      failure; it can provide both sedation and analgesia without inducing respiratory depression.
      Despite these advantages, it is currently used by less than 5% of pulmonologists/
      intensivists as the primary sedative option during NPPV and has not been studied in a
      controlled fashion in this population. Therefore, dexmedetomidine may prove to be more
      efficacious and safe compared to standard sedation/analgesic therapy during NPPV.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.; Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
Other intervention name(s): Precedex; Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment