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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 ÎČ2 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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salbutamol 2,5 mg | Active Comparator | 25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes |
|
| Salbutamol 5mg | Active Comparator | 25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salbutamol 2,5 mg | Drug | 20 min nebulization of 2.5 mg of salbutamol |
|
| Measure | Description | Time Frame |
|---|---|---|
| QT interval | changes of QT interval after salbutamol nebulisation | one hour |
| corrected QT (QTc) interval using Bazett's (QTcB) correction | changes of QTc interval after salbutamol nebulisation | one hour |
| corrected QT (QTc) interval using Framingham (QTcF) correction | changes of QTc interval after salbutamol nebulisation | one hour |
| Tpeak-Tend | changes in transmural dispersion of repolarization after salbutamol nebulisation | one hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz JasiĆski, MD | Medical University of Gdansk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre | Gdansk | 80-214 | Poland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30242825 | Derived | Jasinski T, Owczuk R, Wujtewicz M. The effect of nebulized salbutamol on atrial electrical properties in mechanically ventilated critically ill patients - a randomized, double-blind study. Anaesthesiol Intensive Ther. 2018;50(4):270-276. doi: 10.5603/AIT.a2018.0031. Epub 2018 Sep 22. |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Salbutamol 5mg | Drug | 20 min nebulization of 5 mg of salbutamol |
|
|
| Medical University of GdaĆsk - Departament of Anesthesiology and Intensive Care |
| Gdansk |
| 80-214 |
| Poland |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |