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

Primary Purpose

Acute Respiratory Failure

Status
Active
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dexmedetomidine
Standard Clinical Practice
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Araba University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexmedetomidine

Standard Clinical Practice

Arm Description

Dexmedetomidine according to the stablished protocol

The physician in charge will decide the treatment to be administered (if deemed necessary) in accordance with the protocol established at the department

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To determinate NIV duration of NIV in each group.
Number of hours the patient will be on NIV.
To analyse stay at the ICU in each group.
Number of days patients stay at the ICU until they are discharged home or die.
To analyse hospital stay in each group
Number of days patients remain at the hospital until they are discharged home or die.
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.
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.
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.
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.
To report the course of ARF in each group.
Based on the presence before the start of 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.
To report the adverse effects of dexmedetomidine.
Bradycardia, hypotension, tachycardia, hypertension and/or transient respiratory depression.
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.

Full Information

First Posted
October 27, 2016
Last Updated
March 10, 2022
Sponsor
Basque Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT02958150
Brief Title
Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
Acronym
DEX-PCH-VMNI
Official Title
Randomised Clinical Trial: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine according to the stablished protocol
Arm Title
Standard Clinical Practice
Arm Type
Active Comparator
Arm Description
The physician in charge will decide the treatment to be administered (if deemed necessary) in accordance with the protocol established at the department
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Type
Procedure
Intervention Name(s)
Standard Clinical Practice
Primary Outcome Measure Information:
Title
To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial.
Description
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.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
To determinate NIV duration of NIV in each group.
Description
Number of hours the patient will be on NIV.
Time Frame
72 hours
Title
To analyse stay at the ICU in each group.
Description
Number of days patients stay at the ICU until they are discharged home or die.
Time Frame
An average of 5 days
Title
To analyse hospital stay in each group
Description
Number of days patients remain at the hospital until they are discharged home or die.
Time Frame
15 days
Title
To compare all-cause mortality at the ICU in both groups.
Description
Percentage of all deaths from any cause in patients with ARF on NIV at the ICU in both study groups.
Time Frame
Through study completion, an average of 3 years
Title
To compare specific mortality at the ICU in both groups.
Description
Percentage of deaths attributable to ARF in patients on NIV at the ICU in both study groups.
Time Frame
Through study completion, an average of 3 years
Title
To analyse hospital-specific mortality.
Description
Percentage of all deaths attributable to ARF in patients on NIV at the ICU discharged to a ward in the 2 study groups.
Time Frame
Through study completion, an average of 3 years
Title
To analyse all-cause hospital mortality.
Description
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.
Time Frame
Through study completion, an average of 3 years
Title
To report the course of ARF in each group.
Description
Based on the presence before the start of NIV
Time Frame
1 and 24 hours after NIV
Title
To report NIV tolerance during administration of dexmedetomidine versus SCP.
Description
Nausea and/or vomiting, Aspiration pneumonia, delirium, agitation, interface tolerance or pain secondary to use of interface.
Time Frame
During administration of dexmedetomidine/SCP and up to 24 hours after drug infusion/SCP is completed.
Title
To report the adverse effects of dexmedetomidine.
Description
Bradycardia, hypotension, tachycardia, hypertension and/or transient respiratory depression.
Time Frame
During drug administration and up to 24 hours after drug infusion is completed.
Title
To asses patient satisfaction with dexmedetomidine as compared to SCP
Description
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.
Time Frame
Through study completion, an average of 3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Vallejo
Organizational Affiliation
Basque Health Service: Araba University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Araba University Hospital
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain

12. IPD Sharing Statement

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Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

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