Asthma, Bronchospasm, Critical Illness
Conditions
Brief summary
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.
Interventions
DRUGKetamine
Active treatment
DRUGFentanyl
Sponsors
Hospital Nossa Senhora da Conceicao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bronchospasm improvement | 3 hours post beginning of drug infusion | Maximal airway resistance reduction in hour 3-post beginning of drug infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bronchospasm improvement | 24 hours post beginning of drug infusion | Maximal airway resistance reduction in 24th hour post beginning of drug infusion |
| Time to weaning | Time (in days) to first spontaneous breathing trial post randomization up to 28 days | Time (in days) to first spontaneous breathing trial post randomization up to 28 days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dynamic complacence improvement | 3 hours and 24 hours post beginning of drug infusion | — |
| Blood pressure | 3 hours and 24 hours post beginning of drug infusion | Blood pressure variation in 3 hours and 24hours post beginning of drug infusion |
| Air trapping improvement | 3 hours and 24 hours post beginning of drug infusion | intrinsic PEEP reduction in 3 and 24h post beginning of drug infusion |
| Heart rate | 3 hours and 24 hours post beginning of drug infusion | Heart rate in 3 hours and 24h post beginning of drug infusion |
Countries
Brazil
Outcome results
None listed