Back to resultsRisk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology
Primary Purpose
Pneumothorax, Chest Tube, Pleural Diseases
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Clamping
Non Clampling
Sponsored by
About this trial
This is an interventional treatment trial for Pneumothorax focused on measuring Chest tube, Pneumothorax, Pleural Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients aged 16 years and more.
- Patients hospitalized in the National Institute of Respiratory Diseases.
- Patients who had a chest tube placement during their stay at the hospital, by any cause.
Exclusion Criteria:
- Patients who refuse to sign the informed consent and who refuse to participate in the study.
- Patients who die before randomization.
- Patients who gets chest tube removal before being randomized.
Sites / Locations
- National Institute of Respiratory Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Patients with clamping of the chest tube
Patients without clamping of the chest tube
Arm Description
Patients with 6hour clamping prior to removal
Patients will have chest tube removed immediately
Outcomes
Primary Outcome Measures
Incidence of pneumothorax after chest tube removal with chest tube clamping
Cases of pneumothorax after chest tube removal despite clamping
Incidence of pneumothorax after chest tube removal without chest tube clamping
Cases of pneumothorax after chest tube removal despite clamping
Secondary Outcome Measures
Hospital days of stay
Hospital days of stay
Full Information
NCT ID
NCT05243316
First Posted
January 31, 2022
Last Updated
May 30, 2023
Sponsor
National Institute of Respiratory Diseases, Mexico
1. Study Identification
Unique Protocol Identification Number
NCT05243316
Brief Title
Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology
Official Title
Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Respiratory Diseases, Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping.
The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.
Detailed Description
Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal).
Incidence of 24hour pneumothorax after chest tube removal will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Chest Tube, Pleural Diseases
Keywords
Chest tube, Pneumothorax, Pleural Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Randomizing will be masked, as well as data analysis.
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with clamping of the chest tube
Arm Type
Active Comparator
Arm Description
Patients with 6hour clamping prior to removal
Arm Title
Patients without clamping of the chest tube
Arm Type
Sham Comparator
Arm Description
Patients will have chest tube removed immediately
Intervention Type
Procedure
Intervention Name(s)
Clamping
Intervention Description
There will be a randomized selection of patients who will have a clamping of the chest tube 6 hours prior to chest tube removal.
Intervention Type
Procedure
Intervention Name(s)
Non Clampling
Intervention Description
There will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal.
Primary Outcome Measure Information:
Title
Incidence of pneumothorax after chest tube removal with chest tube clamping
Description
Cases of pneumothorax after chest tube removal despite clamping
Time Frame
After 24 hours of procedure
Title
Incidence of pneumothorax after chest tube removal without chest tube clamping
Description
Cases of pneumothorax after chest tube removal despite clamping
Time Frame
After 24 hours of procedure
Secondary Outcome Measure Information:
Title
Hospital days of stay
Description
Hospital days of stay
Time Frame
Through study completion, an average of 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 16 years and more.
Patients hospitalized in the National Institute of Respiratory Diseases.
Patients who had a chest tube placement during their stay at the hospital, by any cause.
Exclusion Criteria:
Patients who refuse to sign the informed consent and who refuse to participate in the study.
Patients who die before randomization.
Patients who gets chest tube removal before being randomized.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Rodriguez, Doctor
Organizational Affiliation
National Institute of Respiratory Diseases
Official's Role
Study Director
Facility Information:
Facility Name
National Institute of Respiratory Diseases
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Database will be available once the protocol is complete
IPD Sharing Time Frame
Once completed for one year
IPD Sharing Access Criteria
Free access
Learn more about this trial
Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology
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