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Evaluation of clinical and peak flowmetry of nebulized Ketamin in acute asthma attack

Protocol summary

Summary
The method of study is explained to all patients, and patient who do not express their consent in writing are not studied. If there are no prohibition factors for the patients based on the inclusion criteria and if there are no exclusion criteria, the sample size of the patients is randomly divided into two groups of case(120 member) and control(120 member). according to the severity of the asthma attack, they will undergo standard asthma treatment according to the reference book protocols . Patients with severe and severe moderate are treated with 2.5 mg inhaled albotrol and 0.5 mg inhalation ipratropium 0.5 mg with a 20 minute interval. Patients with severe onset of severe asthma received 5 mg inhalable albuterol and 0.5 mg inhalation epirubenol At intervals of 20 minutes, three non-vial doses. and 50 mg oral prednisolone are given. In the experimental group, 1mg / kg of ketamine was inhaled in addition to the standard treatment mentioned in 1 doses of 0, minute, and measured PEFR and FEV1in all patients at 0, 20, 40, 60, and 90 minutes after the intervention, . Meanwhile, in the 60th minute, the clinical status of patients (according to Rosen 2014) based on clinical symptoms, the state of consciousness, speaking,HR , RR, , paradoxical rat, the use of accessory respiratory muscles, and wheezing are reassessed and evaluated. Clinical parameters, PEFR and FEV1 are measured before and after 0, 20, 40, 60, and 90 minutes. Respiratory rate, heart rate, blood pressure and oxygen saturation are also recorded. Finally, the difference between the two parameters is the two groups receiving the treatment and statistical analysis

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017063015446N10
Registration date: 2017-07-11, 1396/04/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-07-11, 1396/04/20
Registrant information
Name
Hassan Motamed
Name of organization / entity
Emegency Department , Ahvaz Jundishapour University of Medical Sciences , Ahvaz , Iran
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
motamed-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University Of Medical Science
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-25, 1396/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and peak flowmetry of nebulized Ketamin in acute asthma attack
Public title
Evaluation of clinical and peak flowmetry of nebulized Ketamin in acute asthma attack
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 18 years of age and up to 65 years old, patients with complaints of acute shortness of breath have been referred to the emergency department and According to the early symptoms, asthma was diagnosed ( Triad shortness of breath;diffusion wheezing and cough ) Exclusion criteria: Patients with lungs disorder and asthmatic manifestations such as ILD ... Smokers with more than 10packs per year of smoking, history of chronic bronchitis, acute medical problem, coronary artery disease, cardiac arrhythmia, high intracranial pressure, women Pregnant and nebolizer beta-agonist treatment for the past 6 hours, and mild and severe asthma attack are excluded
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapor University of Medicial Sciences
Street address
Ahvaz Jundishapor University of Medicial Sciences, Golestan st.
City
Ahvaz
Postal code
Approval date
2017-06-16, 1396/03/26
Ethics committee reference number
IR.AGUMS.REC.1396.235

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
FEV1
Timepoint
At 0,20, 40, 60, 90,minutes Since the beginning of the intervention
Method of measurement
Litre, by spirometry

2

Description
Peak Expiratory Flow Rate (PEFR)
Timepoint
At 0,20, 40, 60, 90,minutes Since the beginning of the intervention
Method of measurement
Litre, by spirometry

Secondary outcomes

1

Description
Respiratory rate
Timepoint
Minutes 0, 20, 40, 60and 90 since the beginning of the intervention
Method of measurement
Counting of respiration in one minute

2

Description
Pulse rate
Timepoint
Minutes 0, 20, 40, 60and 90 since the beginning of the intervention
Method of measurement
Counting of pulse in one minute

3

Description
Blood pressure
Timepoint
Minutes 0, 20, 40, 60and 90 since the beginning of the intervention
Method of measurement
mmHg, by sphygmomanometer

4

Description
blood oxygen saturation levels (SpO2)
Timepoint
Minutes 0, 20, 40, 60and 90 since the beginning of the intervention
Method of measurement
Percentage, by pulse oximeter

Intervention groups

1

Description
In the case group, 1 mg / kg of ketamine is inhaled in 1 dose at 0 minuts
Category
Treatment - Drugs

2

Description
in two group,2.5 mg inhaled albotrol. In 3 doses with a 20 minute interval
Category
Treatment - Drugs

3

Description
In both intervention and control groups. Ipratropium 0.5 mg inhaler with a 20 minute interval in three doses
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini and Golestan hospitals in Ahvaz
Full name of responsible person
Dr. Hasan Motamed
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University Of Medical Science
Full name of responsible person
Dr Hassan Motamed
Street address
Department of emergency medicine, Golestan Hospital, Ahvaz, Iran
City
ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University Of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medicial Sciences
Full name of responsible person
Dr. Hassan Motamed
Position
Emergency medicine assistant professor
Other areas of specialty/work
Street address
Golestan hospital, Golestan st.
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
motamed-h@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medicial Sciences
Full name of responsible person
Dr. Hassan Motamed
Position
Emergency medicine assistant professor
Other areas of specialty/work
Street address
Golestan hospital, Golestan st.
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
motamed-h@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapor University of Medicial Sciences
Full name of responsible person
Dr. Hassan Motamed
Position
Emergency medicine assistant professor
Other areas of specialty/work
Street address
Golestan hospital, Golestan St.
City
Ahvaz
Postal code
Phone
+98 61 3374 3079
Fax
Email
motamed.h@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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