Acute Respiratory FailurePhase 4DEX-PCH-VMNINCT02958150
Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
A Phase 4 study testing Dexmedetomidine and Standard Clinical Practice in people with Acute Respiratory Failure, run by Basque Health Service at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Dexmedetomidine and Standard Clinical Practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Respiratory Failure
- Being tested
- Dexmedetomidine, Standard Clinical Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Standard Clinical PracticeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine according to the stablished protocol Receives: Drug: Dexmedetomidine |
| Standard Clinical Practice | Active comparator | The physician in charge will decide the treatment to be administered (if deemed necessary) in accordance with the protocol established at the department Receives: Procedure: Standard Clinical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (11)
To determinate NIV duration of NIV in each group.
Number of hours the patient will be on NIV.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ana Vallejo de la Cueva, Basque Health Service
- Investigators
- Ana Vallejo, Principal investigator, Basque Health Service: Araba University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958150
- Sponsor's protocol ID
- DEX-PCH-VMNI
- Acronym
- DEX-PCH-VMNI
- Status last verified
- Mar 2022
- First submitted
- 27 Oct 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02958150
- Acronym / sponsor ID
- DEX-PCH-VMNI / DEX-PCH-VMNI
- Conditions
- Acute Respiratory Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Oct 2016
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine according to the stablished protocol |
| Standard Clinical Practice | Active comparator | Procedure: Standard Clinical PracticeThe physician in charge will decide the treatment to be administered (if deemed necessary) in accordance with the protocol established at the department |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine |
| Standard Clinical Practice | Procedure or surgery | Standard Clinical Practice |
Primary outcome
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.
11 secondary outcomes
To determinate NIV duration of NIV in each group.
Time frame: 72 hours
To analyse stay at the ICU in each group.
Time frame: An average of 5 days
To analyse hospital stay in each group
Time frame: 15 days
To compare all-cause mortality at the ICU in both groups.
Time frame: Through study completion, an average of 3 years
To compare specific mortality at the ICU in both groups.
Time frame: Through study completion, an average of 3 years
To analyse hospital-specific mortality.
Time frame: Through study completion, an average of 3 years
To analyse all-cause hospital mortality.
Time frame: Through study completion, an average of 3 years
To report the course of ARF in each group.
Time frame: 1 and 24 hours after NIV
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.
To report the adverse effects of dexmedetomidine.
Time frame: During drug administration and up to 24 hours after drug infusion is completed.
To asses patient satisfaction with dexmedetomidine as compared to SCP
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Vallejo principal investigator
Basque Health Service: Araba University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Standard Clinical Practice in people with Acute Respiratory Failure, run by Basque Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.