The outcome assessment of the early tracheotomy and orotracheal intubation in COVID-19 patients.
Design
Two arm parallel group without blinding and randomization
Settings and conduct
The study conducted on the total confirmed COVID-19 patients using the Polymerase Chain Reaction (PCR) technique and radiologic studies that admitted in the ICU centers of a tertiary hospital during one month. All patients required invasive ventilation. The patients categorized into two groups according to methods of airway management and divided randomly into the groups. Data analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows.
Participants/Inclusion and exclusion criteria
All patients required invasive ventilation.
Intervention groups
The early tracheotomy is conduction of tracheotomy surgery within at least 3 days from orotracheal intubation.
The orotracheal intubation is the insertion of an endotracheal tube through the mouth and into the trachea.
Main outcome variables
Mortality rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038542N1
Registration date:2020-04-13, 1399/01/25
Registration timing:retrospective
Last update:2020-04-13, 1399/01/25
Update count:0
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
Shahriar Najafizadeh-Sari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7735 6335
Email address
dr.najafi73@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-06, 1399/01/18
Expected recruitment end date
2020-04-12, 1399/01/24
Actual recruitment start date
2020-04-06, 1399/01/18
Actual recruitment end date
2020-04-12, 1399/01/24
Trial completion date
2020-04-13, 1399/01/25
Scientific title
The comparison between early tracheostomy and orotracheal intubation in critically ill COVID-19 patients.
Public title
Early tracheostomy in COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The critically ill patients who were required mechanical ventilation
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The other similar studies are about the patients who required mechanical ventilation with many different conditions such as severe head trauma, acute respiratory distress syndrome, traumatic patients, etc. This is the first study about early tracheostomy and intubation in critically ill patients with COVID-19.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
No.5, West Mollasadra st., Vanak Sq., Baqiyatallah Hospital, Department of Surgery
City
Tehran
Province
Tehran
Postal code
1655889874
Approval date
2020-04-05, 1399/01/17
Ethics committee reference number
IR.BMSU.REC.1399.055
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
The oxygen blood saturation
Timepoint
Every 12 hours from the first day of hospitalization to the last day
Method of measurement
The pulse oximetry
2
Description
Respiratory rate
Timepoint
0-1-2-3-4-7-14 days after starting intervention
Method of measurement
Counting the number of breaths per minute
3
Description
The mortality rate
Timepoint
10, 20 days after starting intervention
Method of measurement
Counting deaths
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group received medications for the treatment of COVID-19 based on the Fifth Edition of the Novel Corona Virus Guidelines, in addition they indicated for mechanical ventilation and the airway management was selected using the tracheotomy tube within 3 days from intubation.
Category
Treatment - Surgery
2
Description
Control group: Patients in this group received medications for the treatment of COVID-19 based on the Fifth Edition of the Novel Corona Virus Guidelines, in addition they indicated for mechanical ventilation and the airway management was selected using the Orotracheal tube.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Shahriar Najafizadeh
Street address
Vanak sq., Mollasadra St., Baqiyatallah university of medical sciences
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
Dr.najafi73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Baqiyatallah
Full name of responsible person
Hossein Pirmohammadi
Street address
Vanak sq., Mollasadra St., Baqiyatallah university of medical sciences
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
Dr.najafi73@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Early Tracheotomy in COVID-19
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
Shahriar Najafizadeh
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 5, Mollasadra St., Vanak Sq., Baqiyatallah Hospital, Department of Surgery
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8216 2440
Email
dr.najafi73@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shahriar Najafizadeh
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vanak Sq., Mollasadra St., Baqiyatallah University
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 7735 6335
Fax
Email
Dr.najafi73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Shahriar Najafizadeh
Position
Researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Vanak Sq., Mollasadra St., Baqiyatallah University
City
Tehran
Province
Tehran
Postal code
141556437
Phone
+98 21 7735 6335
Fax
Email
Dr.najafi73@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After the completion of the study, the information on the main outcome will be shared.
When the data will become available and for how long
6 months after printing
To whom data/document is available
All researchers can take action.
Under which criteria data/document could be used
Data and results will be available to all researchers for research on COVID-19.
From where data/document is obtainable
Dr.najafi73@yahoo.com
What processes are involved for a request to access data/document
The data will be provided to the applicant after a review and approval of the request within a month.