To measure the effectiveness of small and large size chest drains on patient outcomes in malignant pleural effusion.
Design
Two intervention groups, eight patients to be randomly assigned to each group via Microsoft Excel, a single center, parallel, non-blinded randomized controlled trial.
Settings and conduct
The trial will be conducted in the pulmonology ward of a teaching hospital. Two groups of eight patients will be intubated with a small bore catheter and a large bore chest tube respectively. This trial is not blinded as the investigator and the patient both can see the size of the chest drain.
Participants/Inclusion and exclusion criteria
Only patients with malignant pleural effusion are included.
Patients with hydropneumothorax, pneumothorax, and empyema thoracis are excluded.
Intervention groups
Two groups.
The first group will be inserted with a small bore chest catheter.
The second group will be inserted with a large bore chest tube.
Main outcome variables
Primary outcome: Duration of chest drain and hospitalization.
Secondary outcome: Pain score during the course of intubation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231105059962N1
Registration date:2023-11-09, 1402/08/18
Registration timing:prospective
Last update:2023-11-09, 1402/08/18
Update count:0
Registration date
2023-11-09, 1402/08/18
Registrant information
Name
Ahmed Uzair
Name of organization / entity
Sahiwal medical college and allied teaching hospital Sahiwal
Country
Pakistan
Phone
+92 40 4502470
Email address
rollno225@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-03-01, 1402/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
SMALL BORE CATHETER VERSUS WIDE BORE CHEST TUBE IN THE MANAGEMENT OF MALIGNANT PLEURAL EFFUSION
Public title
Effect of different chest drain size in management of malignant pleural effusion
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Malignant pleural effusion
Exclusion criteria:
Hydropneumothorax
Pneumothorax
Empyema thoracis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
- Simple method of randomization.
- Unit of randomization is individual or patient.
- A table of random numbers to be used for randomization.
- Random sequence to be built by Microsoft Excel.
- Allocation concealment was not carried out.
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 Sahiwal medical college, STH and allied teaching hospitals, Sahiwal-57000, Pakis
Street address
Sahiwal medical college, college road, Sahiwal.
City
Sahiwal
Postal code
57000
Approval date
2023-11-01, 1402/08/10
Ethics committee reference number
81/IRB/SLMC/SWL
Health conditions studied
1
Description of health condition studied
Malignant pleural effusion
ICD-10 code
C78.2
ICD-10 code description
Secondary malignant neoplasm of pleura
Primary outcomes
1
Description
Duration of chest drain and hospitalization.
Timepoint
After the intervention until the improvement of clinical symptoms.
Method of measurement
Clinical assessment and radiology.
Secondary outcomes
1
Description
Pain during the course of intubation.
Timepoint
After the intervention until removal of chest drain.
Method of measurement
1-10 pain scoring by the patient.
Intervention groups
1
Description
Intervention group: Intervention group one will include eight patients with histology proved malignant pleural effusion. They will be intubated with a small bore chest catheter for symptomatic management and upon adequate drainage of pleural fluid for pleurodesis. Catheter will be kept in place until adequate drainage of the effusion. Aim is to define the patient outcomes in terms of duration of chest drain and hospitalization.
Category
Treatment - Devices
2
Description
Intervention group: Intervention group two will include eight patients with histology proved malignant pleural effusion. They will be intubated with large bore chest tubes for symptomatic management and upon adequate drainage of pleural fluid for pleurodesis. Chest tube will be kept in place until adequate drainage of the effusion. Aim is to define the patient outcomes in terms of duration of chest drain and hospitalization.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sahiwal teaching hospital Sahiwal
Full name of responsible person
Ahmed Uzair
Street address
TB ward Sahiwal teaching hospital Sahiwal
City
Sahiwal
Postal code
57000
Phone
+92 312 6114878
Email
rollno225@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sahiwal medical college Sahiwal
Full name of responsible person
Muhammad Imran Hassan Khan
Street address
Sahiwal medical college, college road, Sahiwal
City
Sahiwal
Postal code
57000
Phone
+92 40 4502427
Email
slmcswl@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sahiwal medical college Sahiwal
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
Sahiwal medical college and allied teaching hospital Sahiwal
Full name of responsible person
Ahmed Uzair
Position
Medical Officer
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
TB ward Sahiwal teaching Hospital Sahiwal
City
Sahiwal
Province
Punjab
Postal code
57000
Phone
+92 312 6114878
Email
rollno225@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sahiwal medical college and allied teaching hospital Sahiwal
Full name of responsible person
Ahmed Uzair
Position
Medical Officer
Latest degree
Medical doctor
Other areas of specialty/work
Pulmonology
Street address
TB ward Sahiwal teaching hospital Sahiwal
City
Sahiwal
Province
Punjab
Postal code
57000
Phone
+92 312 6114878
Email
rollno225@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sahiwal medical college and allied teaching hospital Sahiwal
Full name of responsible person
Ahmed Uzair
Position
Medical Officer
Latest degree
Medical doctor
Other areas of specialty/work
Pulmonology
Street address
TB ward Sahiwal teaching hospital Sahiwal
City
Sahiwal
Province
Punjab
Postal code
57000
Phone
+92 312 6114878
Email
rollno225@gmail.com
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
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