Objectives: This study compared high flow oxygen therapy and oxygen at low flow in patients with acute asthma attack admitted in the emergency department.
Design: A prospective double-blind trial pilot study was designed
Method: patients randomly assigned to groups, high flow oxygen therapy and low flow oxygen therapy. Both groups receive other treatments for asthma attack. Outcome variables before, 2 hours and 24 hours after interventions are evaluated.
Participants, the main entry and exit conditions: All patients admitted to the emergency department of Masih daneshvari hospital with acute asthmatic attack in a period of twelve months, that fulfill the acceptance criteria have been enrolled.
Inclusion criteria: history of asthma; aged between 18 and 65 years; Non-smoking; not pregnant; Lack of occupational asthma
Exclusion criteria: critically ill patients requiring intensive care unit (life-threatening asthma); Infiltrates on chest x-ray; Hypercapnic respiratory failure
Interventions: In addition to standard medical treatment, the control group received less than 10 liters per minute flow rate of oxygen. The intervention group also received standard medical treatment in addition to high flow oxygen dampened with over 10 liters per minute.
Outcome variables: the Borg dyspnea score; Vital signs including respiratory rate; heart rate; blood pressure; temperatures; Spirometry; Peak flow meter; blood gases; blood cell counts; immunoglobulin E; Interleukin
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016081727929N2
Registration date:2016-09-10, 1395/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-10, 1395/06/20
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
From research found
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of High-Flow Oxygen Therapy on clinical and spirometry findings in Acute Exacerbation of Asthma
Public title
Effectiveness of High-Flow Oxygen Therapy on clinical and spirometry findings in Acute Exacerbation of Asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Admission criteria: a history of asthma; aged between 18 and 65 years; no history of smoking; no pregnancy; no history of occupational asthma
Exclusion criteria: critically ill patients requiring intensive care unit (life-threatening asthma); infiltrates on chest x-ray ; Hypercapnic respiratory failure
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
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
Ethics committee of shahid beheshti university of medical sciences
Street address
7th Floor, Bldg No.2 shahid beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-08-09, 1395/05/19
Ethics committee reference number
IR.SBMU.NRITLD.REC.1395.230
Health conditions studied
1
Description of health condition studied
Acute asthma
ICD-10 code
J46
ICD-10 code description
Acute severe Asthma
Primary outcomes
1
Description
Respiratory rate
Timepoint
before, 2 and 24 hours after intervention
Method of measurement
Examination
2
Description
Dyspnea score
Timepoint
before, 2 and 24 hours after intervention
Method of measurement
Borg scale
3
Description
arterial oxygen saturation
Timepoint
before, 2 and 24 hours after intervention
Method of measurement
Arterial blood gas analysis
Secondary outcomes
1
Description
peak expiratory flow
Timepoint
before, 2 and 24 hours after intervention
Method of measurement
peak flowmeter
2
Description
forced expiratory volume in 1st second
Timepoint
before, 2 and 24 hours after intervention
Method of measurement
spirometry
Intervention groups
1
Description
Control group: oxygen therapy with low flow (less than 10 liters per minute)
Category
Treatment - Devices
2
Description
The intervention group received high-flow oxygen (between 10 to 50 liters per minute)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
National research institute of tuberculosis and lung diseases
Full name of responsible person
Atefeh Fakharian
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor in Research Affairs shahid Beheshti university of medical sciences
Full name of responsible person
Afshin Rezghi
Street address
7th Floor, Bldg No.2 shahid Beheshti university of medical sciences, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
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 in Research Affairs 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
Sharareh Raeisi
Position
pulmonary medicine fellowship
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Postal code
Phone
+98 21 2712 2000
Fax
Email
shraeisi86@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
national research Institute of Tuberculosis and lung diseases
Full name of responsible person
Atefeh Fakharian
Position
pulmonologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Postal code
Phone
+98 21 2712 2541
Fax
Email
fakharian_2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
National research institute of tuberculosis and lung diseases
Full name of responsible person
Atefeh Fakharian
Position
pulmonologist
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad
City
Tehran
Postal code
Phone
+98 912 103 0850
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)