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Effect of Nebulized Bronchodilators on Heart Rate

Information source: Genesys Regional Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: COPD; CABG Surgery; Sepsis; Shock; Ventilators, Mechanical

Intervention: Levalbuterol (Drug); Albuterol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Genesys Regional Medical Center

Official(s) and/or principal investigator(s):
Fahim Khorfan, MD, Principal Investigator, Affiliation: Genesys Regional Medical Center
Kimberly R Barber, PhD, Study Director, Affiliation: Genesys Regional Medical Center


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Primary outcome: Average difference in Heart rate between pre and post breathing treatments

Secondary outcome:


Total number arrhythmias

Detailed description: 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 levalbuterol 0. 63 mg alternating with albuterol 2. 5 mg. Group C received levalbuterol 1. 25 mg alternating with albuterol 2. 5 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Genesys Regional Medical Center, Grand Blanc, Michigan 48439, United States
Additional Information

Starting date: December 2008
Last updated: July 14, 2010

Page last updated: August 23, 2015

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