Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation

NCT02958150 | Unknown Phase 4

• 1 other identifier: DEX-PCH-VMNI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• To determinate NIV duration of NIV in each group.

  72 hours

• To analyse stay at the ICU in each group.

  An average of 5 days

• To analyse hospital stay in each group

  15 days

• To compare all-cause mortality at the ICU in both groups.

  Through study completion, an average of 3 years

• To compare specific mortality at the ICU in both groups.

  Through study completion, an average of 3 years

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine according to the stablished protocol

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

Procedure: Standard Clinical Practice

Interventions

Dexmedetomidine DRUG

Dexmedetomidine

Standard Clinical Practice PROCEDURE

Standard Clinical Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Araba University Hospital

Vitoria-Gasteiz, Álava, 01009, Spain

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ana Vallejo

  Basque Health Service: Araba University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Doctor

Study Record Dates

• First Submitted: October 27, 2016
• First Posted: November 8, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

ES (1)