Evaluation of time required for lung expansion and chest tube resection to compare N-Acetylcysteine and bromhexine in the treatment of pneumothorax
Design
A cross-group trial, without control group and blind strain, randomized on 50 patients in 3 phase, used a lottery container containing 50 balls for randomization
Settings and conduct
After the approval of the plan in the research council of the university and obtaining the code of ethics, sampling will begin among the patients admitted to the surgical ward of Pasteur Hospital in Bam who have the conditions to participate in the study. Randomization will be done first and then people will be randomly divided into 2 groups. Upon arrival, the patient will be photographed on the chest and if the amount of pneumothorax is significant, the patient will be included in the study. N-acetylcysteine and bromhexine are then used as mucolytic drugs
Group 1 consists of 25 people: N-acetylcysteine use and routine treatment under the supervision of a surgeon
Group 2 includes 25 people: taking bromhexine and routine treatment under the supervision of a surgeon
Main outcome variables
The time required for the chest xray to normalize and result in the exit of the chest tube
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220529055014N1
Registration date:2022-06-15, 1401/03/25
Registration timing:prospective
Last update:2022-06-15, 1401/03/25
Update count:0
Registration date
2022-06-15, 1401/03/25
Registrant information
Name
Meysam Abyazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 2873
Email address
meab17811@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of N-acetylcysteine and bromhexine in patients with pneumothorax
Public title
Effect of N-acetylcysteine and bromhexine pneumothorax
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient admitted to the surgical ward
Satisfaction with participation in the study
Patients with traumatic pneumothorax to a significant extent
Exclusion criteria:
Patients with chronic obstrucrive pulmonary disease ( copd )
Asthma
cystic fibrosis
bronchitis
bronchiectasis
AIDS
Patients who have undergone intubation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
First determine a total sample size then randomly Assign a set of them to group A and the rest to group B. For example, in a study with a sample size of 50 people, 25 balls for intervention group A and 25 balls for group Intervention B is placed inside a lottery container and then the balls are randomly recorded without being replaced from the container and the resulting sequence is recorded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Bam University of Medical Sciences
Intervention group: In this group, pneumothorax patients are treated orally for one week by implanting chest tube and taking bromhexine tablets, a product of Aveh Sina Pharmaceutical Company, at a dose of 8 mg once a day. Then the patient is photographed chest and in case of recovery of pneumothorax, the time required for chest tube exit is recorded and examined
Category
Treatment - Drugs
2
Description
Intervention group: In this group, pneumothorax patients are treated by chest tube implantation and N-acetylcysteine, a product of Aveh Sina Pharmaceutical Company, at a dose of 600 mg as a solution in 30cc of water, every 12 hours orally for one week. Take. Then the patient is photographed chest and in case of recovery of pneumothorax, the time required for chest tube exit is recorded and examined
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasteur Hospital of Bam
Full name of responsible person
Fatemeh kamali
Street address
Kerman, Bam, km 5 of Bam road, Barvat
City
Bam
Province
Kerman
Postal code
0344431940
Phone
+98 34 4431 9404
Email
Pastor@mubam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Sajjad Khosravi
Street address
Bam - Persian Gulf Highway - University Campus
City
Bam
Province
Kerman
Postal code
7661771967
Phone
+98 34 4421 9074
Email
sci@mubam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bam 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
Bam University of Medical Sciences
Full name of responsible person
Hossein Rezaei
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Bam - Persian Gulf Highway - University Campus
City
Bam
Province
Kerman
Postal code
7661771967
Phone
+98 34 4421 9074
Email
Hossein.rezaei.aliabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Mojtaba Khojandi
Position
Faculty Member
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Bam - Persian Gulf Highway - University Campus
City
Bam
Province
Kerman
Postal code
7661771967
Phone
+98 34 4421 9074
Email
Mojtabakhojandi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bam University of Medical Sciences
Full name of responsible person
Hossein Rezaei
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Biostatistics
Street address
Bam - Persian Gulf Highway - University Campus
City
Bam
Province
Kerman
Postal code
7661771967
Phone
+98 34 4421 9074
Email
Hossein.rezaei.aliabadi@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
Clinical information (including therapeutic outcomes) and demographics Pneumothorax patients treated with N-acetylcysteine and bromhexine
When the data will become available and for how long
About a year
To whom data/document is available
Public
Under which criteria data/document could be used
Detailed study information can be made available to interested researchers Treat patients
From where data/document is obtainable
Author responsible for the study
What processes are involved for a request to access data/document
Competent and enthusiastic researchers can document the data after publication Work of the responsible author by providing academic information and self-identification To receive