Nebulized Hypertonic Saline for Inpatient Use in COPD

OhioHealth70 enrolled

Overview

A comparison of albuterol treatments using hypertonic saline (3%) versus standard saline (0.9%) in patients with admitted patients COPD in regard to Modified Borg Dyspnea scale scores after 4 treatments within 24 hours.

Hypothesis: A clinically significant difference exists between albuterol treatments with nebulized 3% saline versus standard saline, for improvements in the patient's modified Borg dyspnea score during an acute exacerbation of COPD.Study Population: This study will involve 146 patients admitted to Doctors Hospital in Columbus, Ohio from September 2014 through September 2015 with a clinical diagnosis of an acute exacerbation of COPD, defined as an increase in the patient's dyspnea, cough, or change in sputum consistency/volume/color from the patient's baseline during stable conditions. Study Design: Patients will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline. Once the patient is enrolled, they will be randomly assigned to 2.5 mg albuterol treatments with either normal saline, as is the standard, or hypertonic saline. They will then receive the 2.5mg albuterol treatment, and saline solution as determined by the randomization plan (Group 1 will receive 0.9% saline and Group 2 will receive 3% saline), every six hours for at least the first 24 hours, with allowance for PRN (pro re nata= as needed) use every four hours by patient request. The patient's dyspnea will be evaluated prior to starting the treatment and after the intervention period is completed using the Modified Borg Dyspnea Scale.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

hypertonic salineDRUG

standard salineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients at least 18 years of age * Admitted to Doctors Hospital with a clinical diagnosis of COPD * Documented obstruction on spirometry from prior records available at the time of the study. Exclusion Criteria: * Patients younger than 18 years of age * Spirometry data not available * History of smoking less than twenty pack-years * Possibility of other primary cause of the patient's change in dyspnea or cough (e.g. pneumonia, congestive heart failure with pulmonary edema, myocardial infarction) * Patient is found to have a different primary cause after initial enrollment * Non-English speaking subjects

Locations (1)

Doctors Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale

This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein "0" indicates no difficulty breathing, and "10" indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates "very, very slight (just noticeable) difficulty in breathing." A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing.

Time frame: Pre-treatment (baseline) vs. 24 hours post-treatment

Secondary Outcomes

30 Day Readmission

Documented hospital readmission 30 days post discharge

Time frame: 30 days post discharge

30 Day All Cause Mortality

Documented mortality at 30 days post discharge

Time frame: 30 days post discharge

Data from ClinicalTrials.gov

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