Effect of Nebulized Bronchodilators on Heart Rate

Study Overview
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Brief Summary
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The purpose of the study is to determine adverse events rates of nebulized albuterol versus levalbuterol among adult critically ill patients and determine if a differential exists in adverse events between the two drugs.

Detailed Description
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A randomized, single-blind, cross-over, prospective study was conducted in seventy critically ill adult patients with acute air flow obstruction. Patients were randomized to nebulized albuterol alternating with levalbuterol every 4 to 6 hours. Group A received albuterol 2.5 mg alternating with levalbuterol 0.63 mg. Group B received albuterol 2.5 mg alternating with levalbuterol 1.25 mg. All patients received nebulized ipratropium bromide 500 micrograms with each treatment. Heart rate and cardiac rhythm were continuously recorded before and 15 minutes after finishing each treatment. Any new rhythm abnormalities between treatments were also recorded.

Official Title
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Prospective Trial of Effect of Nebulized Bronchodilators on Heart Rate and Arrhythmias in Critically Ill Adult Patients

Conditions
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COPD, Sepsis, Shock

Intervention / Treatment
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* Drug: Levalbuterol
* Drug: Albuterol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults who required inhaled bronchodilator therapy in the form of short acting beta adrenergic receptor agonist and short acting anti-cholinergic treatment every 4-6 hours for respiratory functions Exclusion Criteria: Known allergy or sensitivity to study medications Baseline heart rate was greater than 110 beats per minute

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levalbuterol 0.63<br>Patients received an initial dose of levalbuterol 0.63 mg alternating with albuterol 2.5 mg. | Drug: Levalbuterol<br>* inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg<br>* Other names: ipratropium;Drug: Albuterol<br>* Nebulized albuterol 2.5mg<br>* Other names: Salbutamol;|
| Active Comparator: Levalbuterol 1.25<br>Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg. | Drug: Levalbuterol<br>* inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg<br>* Other names: ipratropium;Drug: Albuterol<br>* Nebulized albuterol 2.5mg<br>* Other names: Salbutamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate in Beats Per Minute | Average difference in Heart rate between pre and post breathing treatments | Five days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmias | Any new arrhythmia documented in the medical record that occurred between breathing treatments. | 15 minutes after each treatment for average of 3 to 5 days | 
| Total Number of Participants With Arrhythmias | Documented new arrhythmia occurring during study. | Five days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tachycardia, tachyarrhythmias, bronchodilator therapy, Critically ill patients