Nebulized Bronchodilators and Cardiac Repolarization

Not Applicable

Completed

• Conditions: Influence of Nebulized Bronchodilatators on Selected; Electrophysiological Parameters
• Interventions: Drug: Salbutamol 2,5 mg; Drug: Salbutamol 5mg

• Registration Number: NCT01714401
• Lead Sponsor: Medical University of Gdansk

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-24
• Study First Posted: 2012-10-25
• Primary Completion: 2013-05-30
• Study Completion: 2013-12-31
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salbutamol 2,5 mg	Salbutamol 2,5 mg	25 mechanically ventilated patients to receive 2,5mg of nebulised salbtamol (Ventolin) duration of nebulisation - 20 minutes
Salbutamol 5mg	Salbutamol 5mg	25 mechanically ventilated patients 5 mg of nebulised salbutamol (Ventolin) duration of nebulisation - 20 minutes

Primary Outcome Measures

Name	Time	Method
corrected QT (QTc) interval using Bazett's (QTcB) correction	one hour	changes of QTc interval after salbutamol nebulisation
Tpeak-Tend	one hour	changes in transmural dispersion of repolarization after salbutamol nebulisation
QT interval	one hour	changes of QT interval after salbutamol nebulisation
corrected QT (QTc) interval using Framingham (QTcF) correction	one hour	changes of QTc interval after salbutamol nebulisation

Trial Locations

Locations (2)

Medical University of Gdansk - Departament of Anesthesiolog and Intensive cCre; 🇵🇱 Gdansk, Poland

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care; 🇵🇱 Gdańsk, Poland