Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02958150
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Vallejo de la Cueva, Basque Health Service

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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Drug: Dexmedetomidine Procedure: Standard Clinical Practice Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial. [ Time Frame: 72 hours ]
    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.


Secondary Outcome Measures :
  1. To determinate NIV duration of NIV in each group. [ Time Frame: 72 hours ]
    Number of hours the patient will be on NIV.

  2. To analyse stay at the ICU in each group. [ Time Frame: An average of 5 days ]
    Number of days patients stay at the ICU until they are discharged home or die.

  3. To analyse hospital stay in each group [ Time Frame: 15 days ]
    Number of days patients remain at the hospital until they are discharged home or die.

  4. To compare all-cause mortality at the ICU in both groups. [ Time Frame: Through study completion, an average of 3 years ]
    Percentage of all deaths from any cause in patients with ARF on NIV at the ICU in both study groups.

  5. To compare specific mortality at the ICU in both groups. [ Time Frame: Through study completion, an average of 3 years ]
    Percentage of deaths attributable to ARF in patients on NIV at the ICU in both study groups.

  6. To analyse hospital-specific mortality. [ Time Frame: Through study completion, an average of 3 years ]
    Percentage of all deaths attributable to ARF in patients on NIV at the ICU discharged to a ward in the 2 study groups.

  7. To analyse all-cause hospital mortality. [ Time Frame: Through study completion, an average of 3 years ]
    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.

  8. To report the course of ARF in each group. [ Time Frame: 1 and 24 hours after NIV ]
    Based on the presence before the start of NIV

  9. To report NIV tolerance during administration of dexmedetomidine versus SCP. [ Time Frame: During administration of dexmedetomidine/SCP and up to 24 hours after drug infusion/SCP is completed. ]
    Nausea and/or vomiting, Aspiration pneumonia, delirium, agitation, interface tolerance or pain secondary to use of interface.

  10. To report the adverse effects of dexmedetomidine. [ Time Frame: During drug administration and up to 24 hours after drug infusion is completed. ]
    Bradycardia, hypotension, tachycardia, hypertension and/or transient respiratory depression.

  11. To asses patient satisfaction with dexmedetomidine as compared to SCP [ Time Frame: Through study completion, an average of 3 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958150


Contacts
Layout table for location contacts
Contact: Ana Vallejo 945007280 ANA.VALLEJODELACUEVA@osakidetza.eus

Locations
Layout table for location information
Spain
Araba University Hospital Recruiting
Vitoria, Álava, Spain, 01009
Contact: Ana Vallejo    945007280    ANA.VALLEJODELACUEVA@osakidetza.eus   
Sponsors and Collaborators
Basque Health Service
Investigators
Layout table for investigator information
Principal Investigator: Ana Vallejo Basque Health Service: Araba University Hospital

Layout table for additonal information
Responsible Party: Ana Vallejo de la Cueva, Registered Doctor, Basque Health Service
ClinicalTrials.gov Identifier: NCT02958150     History of Changes
Other Study ID Numbers: DEX-PCH-VMNI
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action