Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

NCT ID: NCT02958150

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2022-10-31

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.

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexmedetomidine

Dexmedetomidine according to the stablished protocol

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Standard Clinical Practice

Intervention Type: PROCEDURE

Interventions

Dexmedetomidine

Intervention Type: DRUG

Standard Clinical Practice

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ana Vallejo de la Cueva

Registered Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Vallejo

Role: PRINCIPAL_INVESTIGATOR

Basque Health Service: Araba University Hospital

Locations

Araba University Hospital

Vitoria-Gasteiz, Álava, Spain

Countries

Spain

Other Identifiers

DEX-PCH-VMNI

Identifier Type: -

Identifier Source: org_study_id