Electrophysiological Parameters, Influence of Nebulized Bronchodilatators on Selected
Conditions
Brief summary
Patients of the ICU's often require bronchodilatory treatment due to bronchospasm caused by conditions like : acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD) or asthma. The β2 adrenergic drugs are one of the most commonly used for this purpose. However it is known that they may cause tachycardia and may have substantial proarrhythmic effect. The investigators' aim is to estimate the influence of nebulized bronchodilatory drugs on selected electrophysiological parameters, whose changes are generally recognized as potentially increasing the risk of ventricular and supraventricular arrhythmias. Two drugs will be compared - salbutamol given in two doses and ipratropium bromide
Detailed description
50 mechanically ventilated patients above 18 years of age and with presence of clinical features of bronchospasm requiring treatment with nebulised short-acting beta-2 mimetic. Participants will be randomly allocated into two equal groups: a group that was to receive the dose of 2.5 mg and a group that was to receive the dose of 5 mg of nebulised salbutamol. The duration of nebulisation will be set for 20 minutes and Holter ECG data are to be recorded for 60 minutes from the initiation of the nebuliser. The acquired Holter ECG data will be analysed at 10 time points: before salbutamol administration and 5, 10, 15, 20, 25, 30, 40, 50, and 60 minutes following initiation of nebulisation. Changes in QT interval, corrected QT intervals calculated using Bazett's correction and the Framingham formula and transmural dispersion of repolarization TDR will be assessed.
Interventions
DRUGSalbutamol 2,5 mg
20 min nebulization of 2.5 mg of salbutamol
DRUGSalbutamol 5mg
20 min nebulization of 5 mg of salbutamol
Sponsors
Medical University of Gdansk
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* the necessity of b2 adrenergics an m2 mimetics administration
Exclusion criteria
* patients with past medical history of ventricular arrhythmias ( ventricular tachycardia, ventricular fibril, Torsade de pointes) * patients with persistent atrial fibrillation * patients with abnormal plasma sodium, potassium, magnesium, and ionized calcium concentration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QT interval | one hour | changes of QT interval after salbutamol nebulisation |
| corrected QT (QTc) interval using Bazett's (QTcB) correction | one hour | changes of QTc interval after salbutamol nebulisation |
| corrected QT (QTc) interval using Framingham (QTcF) correction | one hour | changes of QTc interval after salbutamol nebulisation |
| Tpeak-Tend | one hour | changes in transmural dispersion of repolarization after salbutamol nebulisation |
Countries
Poland
Outcome results
None listed