Determining the effect of perone position in patients with covid 19 with respiratory failure treated with non-invasive ventilation methods
Design
Patients with acute respiratory failure who, despite BIPAP treatment, still have low saturation and a pao2 to FIO2 ratio of less than 300 who are admitted to the intensive care unit during the study period.
Settings and conduct
Patients with acute respiratory failure whose oxygenation does not rise with BiPAP and other non invasive ventilation method, are placed on their chests and their levels of saturation and blood gases are measured.
Participants/Inclusion and exclusion criteria
Coronary patients with acute respiratory failure hospitalized in the intensive care unit with a desire to cooperate
Intervention groups
In patients with acute respiratory failure who have not responded to treatment with non-invasive ventilation and still have low oxygen. The patient is asked to lie on his stomach, after which the patient's oxygenation and pao2 improvement will be measured.
Main outcome variables
Oxygenation of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150107020592N25
Registration date:2020-06-13, 1399/03/24
Registration timing:retrospective
Last update:2020-06-13, 1399/03/24
Update count:0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
Seyed Mohammad Reza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 9944
Email address
iran.criticalcare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prone position effectiveness in Non invasive ventilation of covid-19 patients undergoing respiratory failure
Public title
Prone position effectiveness in Non invasive ventilation of covid-19 patients undergoing respiratory failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive covid patients
Patients hospitalized in the intensive care unit
Patients with acute respiratory failure
Exclusion criteria:
Patients with increased cerebral pressure
Patients with increased ocular pressure
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Masih Daneshvari Hospital the Edjucational , Research and Treatment center.
Street address
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Approval date
2020-03-10, 1398/12/20
Ethics committee reference number
IR.SBMU.NRITLD.REC.1399.009
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 Disease
Primary outcomes
1
Description
Oxygenation
Timepoint
Up to four days after pron position
Method of measurement
pulse Oximetry
Secondary outcomes
empty
Intervention groups
1
Description
Patients with acute respiratory failure who are being treated for non-invasive ventilation will be put into a prone position, and their saturation and respiratory gas will be measured within four days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Seyyed Mohammadreza Hashemian
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 2265
Email
iran.criticalcare@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr.seyyad mohammadreza hashemian
Street address
End of niavaran,Darabad
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2610 9512
Email
iran.criticalcare@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Hashemian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 912 111 9279
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Mohammad reza hashemian
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Darabad, Niavaran Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Phone
+98 21 2610 9512
Fax
Email
smrhashemian@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All patient information can be published after deleting the name
When the data will become available and for how long
It will take a month from the time of application
To whom data/document is available
All professors of medical universities in the country
Under which criteria data/document could be used
If the professors present their proposal and letter from their university by sending a message to Dr. Hashemian's e-mail, they will send their e-mail request and the names and numbers of the patients will be deleted and their questionnaires, data and analysis will be sent to their e-mails.
From where data/document is obtainable
professor hashemian in masih daneshvari hospital
What processes are involved for a request to access data/document