Evaluation of necessity of obtaining chest x-ray after chest tube removal
in patients with pneumothorax
Design
Clinical trial with an intervention group, with a parallel group; single blind, random
Settings and conduct
This study is conducted in Imam Reza Birjand Hospital, South Khorasan Province. 54 patients are randomly divided into two intervention groups (A) and (B).
Participants/Inclusion and exclusion criteria
Our study population, patients with pneumothorax hospitalized in Imam Reza Hospital, who had a chest tube implanted for them and whose chest tube was removed at the time of discharge, will be included in the study if they agree to conduct the research. Exclusion criteria: pleural effusion in the patient; the need to reinsert the chest tube after discharge (for example, due to accidents, lung diseases, etc.); hemothorax in the patient; symptoms immediately after removing the chest tube; mechanical ventilation and surgical intervention will be performed in the patient except chest tube insertion.
Intervention groups
The intervention groups are as follows: Group one (A): after pulling the chest tube, if there are no symptoms, CXR will be taken 2 hours later and if it is normal, they will be discharged, and in the second group (B): the group that After chest tube removal, if there are no clinical symptoms, they will be observed in the hospital for at least 4 hours, depending on the doctor's opinion, and then they will be discharged.
Main outcome variables
Taking a chest x-ray and inserting a chest tube
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043934N20
Registration date:2023-09-13, 1402/06/22
Registration timing:prospective
Last update:2023-09-13, 1402/06/22
Update count:0
Registration date
2023-09-13, 1402/06/22
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of necessity of obtaining chest x-ray after chest tube removalin patients with pneumothorax
Public title
It is necessary to take a chest X-ray after removing the chest tube
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chest tube removal during patient discharge
Patient consent to participate in the study
Exclusion criteria:
Pleural effusion in the patient
The need to reinsert the chest tube after discharge (for example, due to accidents, lung diseases, etc.)
Hemothorax in the patient
Symptoms immediately after removing the chest tube
Mechanical ventilation
Surgical intervention except for the installation of the chest tube
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
Randomization description
The placement of people in each group will be simple random and in a blocked method, in one of the two groups A (after pulling the chest tube if there are no symptoms, CXR was taken 2 hours later and they were discharged if they were normal. ), group B (the group who were observed in the hospital for at least 4 hours after pulling the chest tube if there were no clinical symptoms, depending on the doctor's opinion, and then they were discharged). In this way, first, various blocks of four (AABB, BBAA, ABAB, BABA, ABBA and BABA) are created on different cards. One of these blocks will be randomly selected using the lottery method and the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well. This will be done by the study manager.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome evaluator: The study administrator (final year medical student) examines and records the desired variables without knowing the placement of patients in two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand, South Khorasan, Iran.
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.BUMS.REC.1400.372
Health conditions studied
1
Description of health condition studied
Pneumothorax
ICD-10 code
J93.11
ICD-10 code description
Primary spontaneous pneumothorax
Primary outcomes
1
Description
Recurrent pneumothorax
Timepoint
Before entering the study and 5 days after discharge from the hospital
Method of measurement
Physical examination by the study manager and questions about the clinical symptoms of the patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First intervention group: After chest tube removal, if there are no symptoms, CXR will be taken 2 hours after them, and if they are normal, they will be discharged.
Category
Treatment - Surgery
2
Description
Intervention group: The second intervention group: the group that after pulling the chest tube, if there are no clinical symptoms, they are observed in the hospital for at least 4 hours, depending on the doctor's opinion, and then they are discharged.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital_Birjand
Full name of responsible person
Mahshid Masbogh
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd,
City
Birjand
Province
South Khorasan
Postal code
9717964151
Phone
+98 56 3162 2001
Email
valiasr@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Miri
Street address
Vice Chancellor for Research and Technology, Birjand University of Medical Sciences, Ghaffari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 915 104 6738
Email
oabstudent@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Mohsen Najmaddini
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3222 2300
Email
oabstudent@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaqiq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd,
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
zabihullahmohaghegh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish individual patient information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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