Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation (DEX-PCH-VMNI)

Randomised Clinical Trial: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Drug: Dexmedetomidine; Procedure: Standard Clinical Practice

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Álava
    • Vitoria, Álava, Spain, 01009
      • Araba University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine; Dexmedetomidine according to the stablished protocol	Drug: Dexmedetomidine
Active Comparator: Standard Clinical Practice; The physician in charge will decide the treatment to be administered (if deemed necessary) in accordance with the protocol established at the department	Procedure: Standard Clinical Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial.	Need for intubation is defined as the presence of any of the following: SpO2<80% or P aO2/FiO2<150, seizures, poor secretion management, hypercapnia and pH<7.20, hypotension: systolic blood pressure (SBP)<80 mmHg refractory despite administration of vasoactive amines or electrocardiogram (ECG) with ischaemic changes or ventricular arrhythmia resulting from myocardial hypoxia.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determinate NIV duration of NIV in each group.	Number of hours the patient will be on NIV.	72 hours
To analyse stay at the ICU in each group.	Number of days patients stay at the ICU until they are discharged home or die.	An average of 5 days
To analyse hospital stay in each group	Number of days patients remain at the hospital until they are discharged home or die.	15 days
To compare all-cause mortality at the ICU in both groups.	Percentage of all deaths from any cause in patients with ARF on NIV at the ICU in both study groups.	Through study completion, an average of 3 years
To compare specific mortality at the ICU in both groups.	Percentage of deaths attributable to ARF in patients on NIV at the ICU in both study groups.	Through study completion, an average of 3 years
To analyse hospital-specific mortality.	Percentage of all deaths attributable to ARF in patients on NIV at the ICU discharged to a ward in the 2 study groups.	Through study completion, an average of 3 years
To analyse all-cause hospital mortality.	Percentage of all deaths from any aetiology of ARF in patients treated with NIV in the ICU discharged to a ward in the 2 study groups.	Through study completion, an average of 3 years
To report the course of ARF in each group.	Based on the presence before the start of NIV	1 and 24 hours after NIV
To report NIV tolerance during administration of dexmedetomidine versus SCP.	Nausea and/or vomiting, Aspiration pneumonia, delirium, agitation, interface tolerance or pain secondary to use of interface.	During administration of dexmedetomidine/SCP and up to 24 hours after drug infusion/SCP is completed.
To report the adverse effects of dexmedetomidine.	Bradycardia, hypotension, tachycardia, hypertension and/or transient respiratory depression.	During drug administration and up to 24 hours after drug infusion is completed.
To asses patient satisfaction with dexmedetomidine as compared to SCP	Patient satisfaction with use of dexmedetomidine as compared to drugs used in SCP will be estimated once NIV and dexmedetomidine/SCP infusion have been completed, using a Likert type questionnaire.	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Basque Health Service
• Investigators: Principal Investigator: Ana Vallejo, Basque Health Service: Araba University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: October 27, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: DEX-PCH-VMNI