Investigating the complications of chest tube removal in the period of 48 hours after insertion and 72 hours after insertion in trauma patients of Sinai Hospital.
Design
The clinical trial has two intervention groups, single-blind, randomized, on 100 patients, block randomization list was used for randomization.
Settings and conduct
Location: Sina Hospital, context: trauma patients who candidate for chest Intubation. procedure : patients are randomly divided into two equal groups, blinding is one-way and only specialist doctors know.
In the first group of patients, the chest tube is clamped for 6 hours 48 hours after implantation, and in the second group of patients, the chest tube is clamped for 6 hours 72 hours after implantation, then a simple chest X-ray is taken
Participants/Inclusion and exclusion criteria
Entry requirements: patients over 18 years old who have an indication for chest tube
Exit: Death before the tube chest
Intervention groups
group 1: trauma patients after chest tube insertion and removal within 48 hours after insertion
group 2: trauma patients after chest tube insertion and removal within 72 hours after insertion
Comparison of the amount of extraction complications of chest tubes within 48 hours and 72 hours after insertion in trauma patients at Sina Hospital
Public title
Comparison of chest tube removal complications in trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Availability of demographic information
Chest tube indication
Age over 18 years
Blunt trauma that caused pneumothorax
Exclusion criteria:
Death before chest tube insertion
Repeated chest tube
Underlying lung disease
Penetrating chest trauma
Presence of hemothorax
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the block randomization list, they are divided into two equal groups. The method of hiding the process of randomization of the list of random allocation of patients was only available to the clinic nurse. In order to hide the random allocation process, the sequence of treatments was written on the cards in order, then the cards were placed in sealed envelopes. A random 10-digit code was written on each envelope without any order or framework, which was the identification number of the relevant patient and only the project methodological was aware of the relevant code.
When the doctor announced the eligibility of a patient, the nurse provided the envelope to the doctor and the desired treatment was carried out based on the type mentioned in the envelope. And the review of the study results was completed by the doctor who was unaware of the type of intervention. Due to the type of treatment, patients will know the type of intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participants do not know about being in two study groups, and the treatment is done for the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of medical faculty of Tehran University of Medical Sciences
Street address
Tehran, Tehran, intersection of Keshavarz Blvd and Qods St., headquarters building of Tehran University of Medical Sciences, 6th floor, room 604, Secretariat of Research Ethics Committee
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.261
Health conditions studied
1
Description of health condition studied
Complications of chest tube removal
ICD-10 code
S17.0
ICD-10 code description
Crushing injury of larynx and trachea
Primary outcomes
1
Description
Recurrence of ex tube
Timepoint
48 and 72 hours after externalization
Method of measurement
questionnaire and Visual Analogue Scale
Secondary outcomes
1
Description
Examining danger symptoms such as shortness of breath, feeling of suffocation, increase in heart rate per minute, increase in breath rate per minute, pain intensity check
Timepoint
Outcome measurement period 48 hours and 72 hours after the intervention
Method of measurement
Visual Analogue Scale, complaint questionnaire
Intervention groups
1
Description
The first intervention group: trauma patients after Intubation and chest tube removal within 48 hours after implantation.
Category
Rehabilitation
2
Description
The second intervention group: trauma patients after Intubation and chest tube removal within 72 hours after implantation.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Seyed Amir Mir_Atashi
Street address
Imam Khomeini Street, Hassan Abad Square, Sina Hospital, Tehran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbar Fotouhi
Street address
Research and Technology Vice-Chancellor, 6th floor, Central Organization of the University, Keshavarz Blvd., corner of Quds St.
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amir Miratashi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Emam Khomeini street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
00982166348500-10
Email
amiratahi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amir Miratashi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam khomeini ave,. sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
Email
amiratahi@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amir Miratashi Yazdi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam khomeini ave,. sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Email
amiratahi@sina.tums.ac.ir
Web page address
https://sinahospital.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
The entire data will be shared after unidentifying people personal data
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to perform further research with the request from the scientific institute
From where data/document is obtainable
Dear applicants will be referred to Sina Hospital's scientific Center for access to Documents and Data or the applicant can email the project executor. the email address is available. (amiratashi@sina.tums.ac.ir)
What processes are involved for a request to access data/document
After receiving the letter from the project executor, the applicant can refer to Sina Hospital Research Center and after the approval of the executor, the documents and data will be available to executor within a week or the applicant can email directly to project executor so the executor provide the information