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Determining the effect of targeted oxygen therapy on the recovery outcomes of Covid-19 patients

Protocol summary

Study aim
Determining the effect of targeted oxygen therapy on the recovery outcomes of Covid-19 patients
Design
Clinical trial with control and intervention group, randomization, phase3 on 80 patients,40 patients in each group and Excel function rand function is used for randomization
Settings and conduct
After a visit to the emergency medicine physician and confirmation of COVID-19 by physician (measurement v/s variables, respiratory retention, six minutes walking, spo2 rate) cardiac symptoms and laboratory variables, the degree of pulmonary involvement, which is taken by CT scan of the lungs based on necessity and indication) and after confirming the inclusion criteria, the patient is placed in the intervention group. Patients with SPO2 <92% in the intervention group and undergoing oxygen therapy with a nasal catheter in the volume of 2-4 liters per minute to reach 92%-93 level of measuring variables before , 24 hours after,and at discharge, will be. Patients in the control group who reach 96% as nasal to spo2 above receive oxygen and are evaluated at three similar times at Baqiyatallah Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with positive PCR - Patients with mild involvement in CT scan - Patients with spo2 <92% Non-entry: Non-participation in the study by the patient - Patients who become ill during the study - Patients who have ICU admission
Intervention groups
Patients with lower spo2 than 92 per cent were placed in volume 2 - 4 litres per minute to reach the 92-93 % level and are measured at this level 92 % and are measured in this level of 92-93 hours (T1)and in the release time (T2).
Main outcome variables
BP, PR, RR, respiratory retention test; six minutes of walking test; spo2 rate; cardiac symptoms and laboratory variables; pulmonary involvement by CT scan of the lungs based on necessity and indication

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211116053079N1
Registration date: 2022-05-10, 1401/02/20
Registration timing: prospective

Last update: 2022-05-10, 1401/02/20
Update count: 0
Registration date
2022-05-10, 1401/02/20
Registrant information
Name
Mojtaba Ferdosi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 0000
Email address
ferdosim732@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-01, 1401/03/11
Expected recruitment end date
2022-09-02, 1401/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of targeted oxygen therapy on the recovery outcomes of Covid-19 patients
Public title
The effect of targeted oxygen therapy on the recovery outcomes of Covid-19 patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with positive pcR Patients with mild lung involvement on CT scan Patients with spo2 Less than 92%
Exclusion criteria:
Failure to continue the intervention Patients who become ill during the project. Patients receiving ICU admission
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be performed after the person participating in the study enters, ie after qualifying to participate in the trial and obtaining the informed consent of the participant in the research, as follows: 1- Creating a random sequence will be done with the help of a random number table 2- Central randomization will be used to hide random allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
After enrolling in the study, patients did not know that they were in the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiatallah University of Medical Sciences Ethical Committee
Street address
South Shikh Bahaei street, Nosrati allay
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2021-11-19, 1400/08/28
Ethics committee reference number
IR.BMSU.BAQ.REC.1400.037

Health conditions studied

1

Description of health condition studied
covid-19
ICD-10 code
covid-19,v
ICD-10 code description
u07.1

Primary outcomes

1

Description
SPo2
Timepoint
Upon arrival, 24 hours after, discharge
Method of measurement
Puls oximetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, oxygen therapy is given in a targeted manner (spo2 = 92-93%) as a nasal catheter in the volume of 2-4 liters per minute and the blood oxygen saturation level is maintained in the range of 92-93% and in three times Before the intervention, 24 hours later and the time of discharge of the consequences is checked. The measurement method is pulse oximetry and is performed until the intervention clears.
Category
Treatment - Other

2

Description
Control group: In the control group, oxygen is routinely or non-purposefully delivered as a nasal catheter. (spo2> 96%) and in the three desired times upon arrival, 24 hours later, the time of discharge of the consequences is checked. The method of measurement is by pulse oximetry.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mojtaba Ferdosi
Street address
Baqiyatallah Hospital, after Sheikh Bahai, Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 7112
Email
Ferdosim732@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Gholam Hossein Ali Shiri
Street address
Baqiyatallah Hospital, after Sheikh Bahai, Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 7112
Email
ghalishiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Baqiyatallah University
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mojtaba Ferdosib
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baqiyatallah Hospital, after Sheikh Bahai, Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 7112
Email
Ferdosim732@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mojtaba Ferdosi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baqiyatallah Hospital, after Sheikh Bahai, Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8126 7112
Email
Ferdosim732@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mojtaba Ferdosi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Baqiyatallah Hospital, after Sheikh Bahai, Mulla Sadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 8126 7112
Email
Ferdosim732@gmail.com

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 documents and data of the participants are after the informed consent and no name and details of the patient are entered.
When the data will become available and for how long
The access period is three months after the results are published.
To whom data/document is available
All professors of medical universities in the country
Under which criteria data/document could be used
Contribute to the advancement of science
From where data/document is obtainable
Ferdosim732@gmail.com
What processes are involved for a request to access data/document
Communicate via email
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