Clinical trial NCT02958150: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
Official title: Randomised Clinical Trial: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Respiratory Failure
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2016-11-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age.
* Competent or with legal representative able to sign inform consent.
* Reversible ARF secondary to heart failure, COPD exacerbation, pneumonia, or at risk of pot-extubation failure\* who meet the criteria for starting NIV.
* Signs and symptoms of respiratory distress or
* Moderate to severe dyspnoea, grater than usual and/or
* Respiratory rate greater than 25 in COPD or greater than 30 in hypoxemic ARF and/or
* Use of accessory muscles and/or paradoxical breathing and/or
* Hypercapnic encephalopathy
* And changes in gas exchange
* PaCO2\>45 mmHg, pH\<7.35 and/or
* PaO2/FiO2 between 300 and 150.

  \*Patients at risk of post-extubation failure: Patients who meet at least one of the following criteria.
* Impaired consciousness.
* Age over 65 years
* Heart failure with EF \>30%
* Severe disease with an Acute Physiology and Chronic Health Evaluation (APSCHE) score \>12.
* Protracted weaning before extubation

Exclusion Criteria:

* Respiratory arrest, direct indication of OTI and IMV.
* Severe unstable comorbidity (myocardial ischemia with ejection fraction \<30%, arrythmia, uncontrolled hypotension defined as systolic blood pressure less than 90 mmHg with doses of norepinephrine\>0.5 mcg/kg/min and/or dobutamine\>10 mcg/kg/min).
* Inability to protect the airway: bronchial aspiration.
* Fixed upper airway obstruction.
* Tracheostomy.
* Undrained pneumothorax.
* Severe agitation or lack of collaboration of the patient despite medication administered.
* Facial burns or trauma.
* Facial surgery or anatomical changes which prevent mask fitting.
* Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
* Allergy to eggs, soya, or peanuts.
* HR\< 50 bpm not induced by beta- blockers.
* Advanced heart block (grade 2 or 3) unless paced.
* Acute cerebrovascular conditions.
* Increased intracranial pressure.
* Closed angle glaucoma.
* Myasthenia gravis.
* Concurrent use of CYP3A4 inhibitors (amprenavir, atazanavir, or ritonavir).
* Refuse to participate in the trial.
* Pregnant or nursing patients.

Primary outcomes:
measure: To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial.
timeFrame: 72 hours
Secondary outcomes:
measure: To determinate NIV duration of NIV in each group.
timeFrame: 72 hours
measure: To analyse stay at the ICU in each group.
timeFrame: An average of 5 days
measure: To analyse hospital stay in each group
timeFrame: 15 days
measure: To compare all-cause mortality at the ICU in both groups.
timeFrame: Through study completion, an average of 3 years
measure: To compare specific mortality at the ICU in both groups.
timeFrame: Through study completion, an average of 3 years
measure: To analyse hospital-specific mortality.
timeFrame: Through study completion, an average of 3 years
measure: To analyse all-cause hospital mortality.
timeFrame: Through study completion, an average of 3 years
measure: To report the course of ARF in each group.
timeFrame: 1 and 24 hours after NIV
measure: To report NIV tolerance during administration of dexmedetomidine versus SCP.
timeFrame: During administration of dexmedetomidine/SCP and up to 24 hours after drug infusion/SCP is completed.
measure: To report the adverse effects of dexmedetomidine.
timeFrame: During drug administration and up to 24 hours after drug infusion is completed.
measure: To asses patient satisfaction with dexmedetomidine as compared to SCP
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Araba University Hospital
state: Álava
Study officials:
affiliation: Basque Health Service: Araba University Hospital
name: Ana Vallejo
role: PRINCIPAL_INVESTIGATOR
References: