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Investigation of Non-invasive Positive Pressure Ventilation in patients with moderate to severe acute exacerbation of asthma

Protocol summary

Summary
(1) Objectives: Investigation of efficiency of noninvasive positive pressure ventilation in patients with moderate and severe asthma attacks referring to the emergency room of Masih Daneshvari Hospital (2) Design: Study population: all patients with moderate and severe asthma attacks referring to the emergency room of Masih Daneshvari Hospital, Sample Size: 34, blinding: double-blind, groups and randomization: random dividing of patients into intervention and control groups, study phase: clinical trial phase 2. (3) Setting and conduct: a) base line assessments in 34 patients, b) performing non-invasive ventilation in the intervention group with the inspiratory pressure equal to 12 cm H2O and expiratory pressure equal to 4 cm H2O via a face mask, c) using a same mask in the control group, d) comparing the results of two groups. (4) Participants including major eligibility criteria: Inclusion criteria: (1) Age between 18-75 years, (2) confirmed diagnosis of asthma. Exclusion criteria: (1) Chronic obstructive pulmonary disease, (2) patients inability to use mask (5) Intervention: in the intervention group: non-invasive ventilation using a face mask with an inspiratory pressure equal to 12 cm H2O and an expiratory pressure equal to 4 cm H2O for 120 minutes. In the control group: using a same mask without any pressure for 120 minutes. (6) Main outcome measures (primary and secondary outcome variables): primary outcome variable: forced expiatory volume in 1st second, secondary outcome variables: arterial PO2, arterial PCO2, blood pressure, heart rate, Dyspnea.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017021427929N4
Registration date: 2017-03-27, 1396/01/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-27, 1396/01/07
Registrant information
Name
Atefeh Fakharian
Name of organization / entity
National research institute of tuberculosis and lung diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2541
Email address
afakharian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti university of medical sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Non-invasive Positive Pressure Ventilation in patients with moderate to severe acute exacerbation of asthma
Public title
Effectiveness of Non-invasive Ventilation in patients with asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-75 years; dyspnea; peak expiratory flow <200cc; respiratory rate >24/minute; confirmed diagnosis of asthma; receiving standard asthma treatment. Exclusion criteria: Chronic obstructive pulmonary disease; unstable vital signs such as systolic blood pressure <90 mmHg after liquid therapy; patient unwillingness to participate in the study; decrease in level of consciousness; acute myocardial infarction or ischemic heart failure; pH<7.10; unable to use mask; inability to clean airway secretions.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 34
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
Shahid Beheshti University of Medical Sciences
Street address
7th Floor , 2nd SBUMS Bldg. ,Next to Ayatollah Taleghani Hospital, Evin
City
Tehran
Postal code
Approval date
2016-05-10, 1395/02/21
Ethics committee reference number
IR.SBMU.MSP.REC.1395.60

Health conditions studied

1

Description of health condition studied
asthma
ICD-10 code
J46
ICD-10 code description
Acute severe asthma

Primary outcomes

1

Description
Forced expiatory volume in 1st second
Timepoint
Before and after intervention
Method of measurement
spirometry

Secondary outcomes

1

Description
arterial PO2
Timepoint
Before and after intervention
Method of measurement
arterial blood gas

2

Description
arterial PCO2
Timepoint
Before and after intervention
Method of measurement
arterial blood gas

3

Description
Blood pressure
Timepoint
Before and after intervention
Method of measurement
Clinical counting

4

Description
Heart rate
Timepoint
Before and after intervention
Method of measurement
Clinical counting

5

Description
Dyspnea
Timepoint
Before and after intervention
Method of measurement
Dyspnea Borg Scale

Intervention groups

1

Description
In the intervention group: non-invasive ventilation is performed via a face mask with an inspiratory pressure equal to 12 cm H2O and an expiratory pressure equal to 4 cm H2O for 120 minutes. Non-invasive ventilation device configurations based on guidelines published by the Lung Association will be conducted in Europe and America.
Category
Treatment - Devices

2

Description
In the control group, a non-invasive device with a face mask without inspiratory and expiratory pressures is placed on the patients faces for 120 minutes.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Atefeh Fakharian
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 , Arabi Ave, Daneshjoo Blvd, Velenjak,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
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
National Research Institute of Tuberculosis and Lung Diseases
Full name of responsible person
Dr. Atefeh Fakharian
Position
Pulmonologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Postal code
Phone
+98 21 2610 5050
Fax
Email
fakharian_2005@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Pulmonologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Postal code
Phone
+98 212127122541
Fax
Email
fakharian_2005@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Fakharian
Position
Pulmonologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout,
City
Tehran
Postal code
Phone
+98 21 2712 2541
Fax
Email
fakharian_2005@yahoo.com
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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