Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

Acute Respiratory Failure Clinical Trial

— DEX-PCH-VMNI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02958150
• Other study ID #: DEX-PCH-VMNI
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: October 2022

Study information

• Verified date: March 2022
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: October 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• Dexmedetomidine

Procedure:
• Standard Clinical Practice

Locations

Country	Name	City	State
Spain	Araba University Hospital	Vitoria	Álava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determinate NIV duration of NIV in each group.	Number of hours the patient will be on NIV.	72 hours
Secondary	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
Secondary	To analyse hospital stay in each group	Number of days patients remain at the hospital until they are discharged home or die.	15 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To report the course of ARF in each group.	Based on the presence before the start of NIV	1 and 24 hours after NIV
Secondary	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.
Secondary	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.
Secondary	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