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Comparative study of the early intubation impact with conventional therapy, complications and outcome in patients with severe chest injury

Protocol summary

Study aim
Comparison of the Effect of Early intubation with Routine Therapy
Design
Clinical trials with control group, with parallel groups, without blindness, randomized
Settings and conduct
Sixty patients who have been referred to Alzahra and Kashani hospitals with Multiple Trauma during the years 1395 and 1396 are enrolled in the study. Patients are visited by an emergency specialist when they arrive at a hospital. A radiologic picture of the chest is performed by the portable patient and by the chest radiography, the patient's score is calculated using the Thoracic Trauma Score table, and if the score is greater than or equal to 5, will randomly enter into an intervention or control group. Intubation of patients in the Rapid sequence intubation and classical intubation is performed in the intervention group. In the control group, necessary routine supportive measures will be performed. Then, in the test group, after one day (24 hours) intubation, if necessary the patient will be extubated, there will be no contraindications. Became Conditions will be the same for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All individuals with multiple trauma; People over 18 years old; Exclusion criteria: Patients with severe head trauma with GCS less than or equal to 8; Patients with respiratory distress whit respiratory rate less than 9 or more than 30;
Intervention groups
For intubation of patients in the test group, a Rapid sequencing intubation and classical intubation will be performe, and in the control group, necessary routine supportive measures will be performed. Then, patients in the test group after one day (24 hours) of intubation will be extubated in the absence of the necessary contraindications.
Main outcome variables
PH, Hco3, Pco2, PaO2,Systolic blood and Diastolic blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130311012782N31
Registration date: 2019-07-06, 1398/04/15
Registration timing: registered_while_recruiting

Last update: 2019-07-06, 1398/04/15
Update count: 0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the early intubation impact with conventional therapy, complications and outcome in patients with severe chest injury
Public title
The effect of early intubation in patients with severe chest pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All individuals with multiple trauma who receive more than or equal to 5 points from the TTS rating system People over 18 years old
Exclusion criteria:
Patients with severe head trauma with GCS less than or equal to 8 Patients with respiratory distress whit respiratory rate less than 9 or more than 30 Airway obstruction Severe Hypoxia Cardiac arrest Severe hemorrhagic shock Burn more than 40% Severe Facial Burn
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization block, randomization unit: Individual, Random layer: not done Randomization, tool: Random sequence generation software (Excel), How to create random sequence: Using random blocks, each block contains 4 people And assign a number from 1 to 6 to each block
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
Isfahan University of medical sciences, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-03-11, 1395/12/21
Ethics committee reference number
IR.MUI.MED.REC.1395.804

Health conditions studied

1

Description of health condition studied
Fracture of rib(s), sternum and thoracic spine
ICD-10 code
S22
ICD-10 code description
Fracture of rib(s), sternum and thoracic spine

Primary outcomes

1

Description
Systolic blood and Diastolic blood pressure
Timepoint
Every three hours until the first 6 hours of admission to the emergency room, then every 6 hours to 18 hours, then daily until discharge from the hospital will be launched.
Method of measurement
Using sphygmomanometer

2

Description
PaO2
Timepoint
Every three hours until the first 6 hours of admission to the emergency room, then every 6 hours to 18 hours, then daily until discharge from the hospital will be launched.
Method of measurement
pulse oximeter

3

Description
Pco2
Timepoint
Every three hours until the first 6 hours of admission to the emergency room, then every 6 hours to 18 hours, then daily until discharge from the hospital will be launched.
Method of measurement
laboratory test for measuring blood acidity

4

Description
Hco3
Timepoint
Every three hours until the first 6 hours of admission to the emergency room, then every 6 hours to 18 hours, then daily until discharge from the hospital will be launched.
Method of measurement
laboratory test for measuring blood acidity

5

Description
PH
Timepoint
Every three hours until the first 6 hours of admission to the emergency room, then every 6 hours to 18 hours, then daily until discharge from the hospital will be launched.
Method of measurement
laboratory test for measuring blood acidity

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intubation of patients in the Rapid sequence intubation and classical intubation is performed in the intervention group
Category
Treatment - Devices

2

Description
Control group: necessary routine supportive measures will be performed
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Amir Bahador Boromand
Street address
Alzahra Hospital, Sofe street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Sciences, Hezar jareeb street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
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
Dr Mohammad Nasr Esfahani
Position
General Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Dermatology group, Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3624 4221
Email
M_nasr@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Nasr Esfahani
Position
General Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Dermatology group, Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3624 4221
Email
M_nasr@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Mohammad Nasr Esfahani
Position
General Surgeon
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Dermatology group, Alzahra hospital, Sofe street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31366855555
Fax
+98 31 3624 4221
Email
M_nasr@med.mui.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 data will be shared
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
People who need this information
Under which criteria data/document could be used
All uses are allowed
From where data/document is obtainable
please contact to this Email address: M_nasr@med.mui.ac.ir
What processes are involved for a request to access data/document
After sending the request, the requested information will be provided to you within a short period of time.
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