Comparison of the effect of high-flow nasal cannula oxygen therapy and nasal cannula oxygen therapy in patients with respiratory failure referred to the emergency department of Al-Zahra Hospital
Design
Single blinded clinical randomised trial
Settings and conduct
In 2020, it will be performed in the emergency room of Al-Zahra Hospital in Isfahan
Participants/Inclusion and exclusion criteria
Patients referred to the emergency room with acute respiratory failure
Intervention groups
Patients are initially treated with regular oxygen with a nasal cannulla for at least 15 minutes. if not increase in Sat O2 patients Randomly divided into two groups and They are treated with high-flow oxygen or continue with regular oxygen therapy
Main outcome variables
Increasing in blood oxygen levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181203041838N2
Registration date:2020-12-02, 1399/09/12
Registration timing:registered_while_recruiting
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Mohammad Nasr-Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2085
Email address
m_nasr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of high-flow nasal cannula oxygen therapy in acute respiratory failure Compared with conventional O2 therepy
Public title
Efficacy of high-flow nasal cannula oxygen therapy in acute respiratory failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with acute respiratory failure
Exclusion criteria:
Unstable hemodynamic
Loss of consciousness
Obesity hypoventilation syndrome
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized parallel groups design, patients who fulfill the inclusion criteria are selected and by permuted block randomization of blocks size 2 randomly divided into 2 groups ( intervention and control). Patients are individually assigned to 2 groups and both groups are equal in number( 33 patient in each group).
Random sequence generation will be done by SPSS statistical software and random sequence concealment will be done by sealed envelopes.
Blinding (investigator's opinion)
Not 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 Isfahan University of Medical Sciences
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-06-23, 1399/04/03
Ethics committee reference number
IR.MUI.MED.REC.1399.249
Health conditions studied
1
Description of health condition studied
Respiratory Failure
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
increase in blood oxygen saturation level
Timepoint
Measuring the percentage increase in blood oxygen saturation level after one hour
Method of measurement
Pulse Oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: High pressure oxygen therapy (60 lit per min o2) In this study Patients with r espiratory failure are admitted to the emergency department. initially they are treated with ordinary oxygen with a nasal cannulla for at least 15 minutes.then in case of no recovery and no increase in Sat O2 in pulseoxymetry patients will be divided into two groups Randomly. They will be treated with high-flow oxygen(up to 60 lit per min) or continue with regular oxygen(up to 10-15 lit per min) .A group of patient used High pressure oxygen for an hour will be compared in O2 sat increse , the amount of need for intubation and the rate of ICU admission with the group that they continue with regular oxygen.(Emergency personnel have already participated in training coarse on how to work with devises.)
Category
Treatment - Devices
2
Description
Control group: nasal cannula oxygen therapy( 10-15 lit per min o2)
Category
Treatment - Other
3
Description
Intervention group: BIPAP non invasive mechanical ventilation(bipap) is also used in this study to comparison approach of high flow o2 and BIPAP . a group of 33 patients with BIPAP will be intervented. they will be compared based on respiratory status , the amount of PCO2 in VBG( before and after treatment ) and need to intubation or ICU addmition.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra medical center
Full name of responsible person
Mohammad Nasr-Esfahani
Street address
Soffeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3822 7000
Email
m_nasr@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar jerib st
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Nasr-Esfahani
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
hezar jerib st
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
m_nasr@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Nasr-Esfahani
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Soffeh Blvd
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3625 5555
Email
m_nasr@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Nasr-Esfahani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Soffeh Blvd
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
m_nasr@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is shared after people are not identified
When the data will become available and for how long
Start of access period from 2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
for research
From where data/document is obtainable
m_nasr@med.mui.ac.ir
What processes are involved for a request to access data/document