Ketamine Efficacy for Acute Severe Bronchospasm in ICU: MACANUDO Trial

Hospital Nossa Senhora da Conceicao45 enrolled

Overview

Despite few scientific evidence that could support the use of ketamine in adult patients undergoing acute bronchospasm requiring mechanical ventilation (MV), ketamine is largely employed in this setting. The aim of this study is therefore assess more definitively the real benefit of using ketamine in patients with severe bronchospasm, requiring ICU stay and need for MV in order to establish or refute the use of this drug as "standard therapy" in these cases.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Critical Illness Asthma Bronchospasm

Interventions

KetamineDRUG

Active treatment

FentanylDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with acute exacerbation of COPD or status asthmaticus, undergoing controlled mechanical ventilation * acute bronchospasm, defined as airway resistance value (Rsr max) greater than 12, use of inhaled therapy with bronchodilators and systemic corticosteroids * patients requiring the use of continuous intravenous sedation for optimization of ventilation Exclusion Criteria: * contraindication or history of previous adverse events with the use of the studied drugs * other diagnostic potential Rsr increase of not causing bronchospasm (bronchial obstruction, acute respiratory distress syndrome adult, pulmonary fibrosis)

Locations (1)

Hospital Nossa Senhora da Conceição

Porto Alegre, Brazil

Outcomes

Primary Outcomes

bronchospasm improvement

Maximal airway resistance reduction in hour 3-post beginning of drug infusion

Time frame: 3 hours post beginning of drug infusion

Secondary Outcomes

bronchospasm improvement

Maximal airway resistance reduction in 24th hour post beginning of drug infusion

Time frame: 24 hours post beginning of drug infusion

Time to weaning

Time (in days) to first spontaneous breathing trial post randomization up to 28 days

Time frame: Time (in days) to first spontaneous breathing trial post randomization up to 28 days

Data from ClinicalTrials.gov

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