Comparison Of The Effect Of Ventolin Nebulizer With And Without Hypertonic Saline 3% On Dyspnea In Patients With Chronic Obstructive Pulmonary Disease
Design
A randomized trial with two intervention and control groups single-blind clinical Randomized, 64 patients with COPD
Settings and conduct
Allameh Bohlool Gonabadi Hospital - Blinding technique: The questionnaire will be completed by a person who will not be aware of allocation of patients to control or intervention groups.
Patients will be randomly divided into intervention and control groups. For control group Ventolin plus 5 cc distilled water and for intervention group, Ventolin plus 5 cc hypertonic saline 3% will be administered. Shortness of breath will be assessed before and after the intervention using borg scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willing to participate in the research
The patient is alert
Patients are known to be COPD or admitted with this diagnosis.
Patients with dyspnea on the Borg scale greater than 3
Ventolin nebulizer is prescribed for the patient
Exclusion criteria: Pregnancy; Nausea and vomiting; Intolerance to the mask used for inhalation therapy.
Intervention groups
Distilled water and 3% hypertonic saline
Main outcome variables
Dyspnea before and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181205041858N1
Registration date:2019-10-16, 1398/07/24
Registration timing:retrospective
Last update:2019-10-16, 1398/07/24
Update count:0
Registration date
2019-10-16, 1398/07/24
Registrant information
Name
Azam Razizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5723 6833
Email address
razizadeh.a@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-26, 1397/11/06
Expected recruitment end date
2019-05-27, 1398/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The Effect of Ventolin Nebulizer With And Without Hypertonic Saline % 3 On Dyspnea In Patients With Chronic Obstructive Pulmonary Disease
Public title
Comparison The Effect of Ventolin Nebulizer With And Without Hypertonic Saline% 3 On Dyspnea In Patients With Chronic Obstructive Pulmonary Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Participate in research.
Be alert
Be known to be COPD or hospitalized with this diagnosis
Have moderate or high dyspnea (at least scale 3 of the bourgeois scale)
Nebulizer Ventolin in patient medication orders which have been ordered by a Internal specialist.
Exclusion criteria:
Patient's death or decreased level of consciousness during treatment
After diagnosis, the patient's shortness of breath is due to myocardial infarction, myocardial infarction, or congestive heart failure.
Patient's unwillingness to continue research
Age
From 19 years old
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
46
More than 1 sample in each individual
Number of samples in each individual:
23
The research samples will be from the referrals to Allame Bohlool Gonabadi Hospital, which will be studied by the specialist with a history of COPD or diagnosis and will be randomly assigned to two groups.
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two experimental and control groups based on permutation blocks (blocks of size 4). It will be listed according to six possible ways (AABB, ABAB, ...) randomly and the arrangment of receiving intervention will be determined accordingly. For blinding the questionnaire will be completed by a person who is not aware of the research unit in the control group or the experimental group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in research and researcher are aware of the research, but the results evaluator is not aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
The intervention group will receive Ventolin plus 5 cc hypertonic saline 3% at intervals of 6 hours as a nebulizer .hypertonic saline 3% at intervals of 6 hours as a nebulizer.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive Ventolin plus 5 cc distilled water at intervals of 6 hours as a nebulizer.