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Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries

Primary Purpose

Pneumothorax and Air Leak, Pneumothorax, Pleura Injury

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Clamping
Urine bag
Sponsored by
Al-Quds University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pneumothorax and Air Leak

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • post lung resection patients (via Uniportal VATS only)
  • Over the age of 18
  • indicated chest tube

Exclusion Criteria:

  • Under the age of 18

Sites / Locations

  • Assiut University
  • Tanta University
  • European Institute of Oncology
  • Makassed HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clamping

Urine bag

Arm Description

This arm will undergo chest drain clamping after a certain criteria has been met. Four hours post clamping a chest x-ray will be made, and the presence of pneumothorax will be assessed. The chest drain will be removed only in the absence of pneumothorax, if pneumothorax persists patients will stay attached to the underwater seal

The second arm will be attached to a urine bag, and bag inflation will be measured after a certain criteria has been met. bag inflation will be assessed four hours after its attachment. Bag inflation indicates the persistence of an air leak, thus the absence of bag inflation indicates the removal of the chest drain

Outcomes

Primary Outcome Measures

Overall cost
The overall cost of the patient's hospital stay

Secondary Outcome Measures

Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag
An important side effect to be studied
total number of days with chest drain inserted
Number of days chest drain remained inserted
Number of chest x-rays
Total number of chest x-rays
Number of participants that faced other intervention associated side effects
Subcutaneous emphysema, tension pneumothorax and others
Number of participants with chest tube re-insertion
An important side effect

Full Information

First Posted
December 20, 2021
Last Updated
January 27, 2022
Sponsor
Al-Quds University
Collaborators
Assiut University, Tanta University, European Institute of Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT05230420
Brief Title
Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries
Official Title
Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
November 25, 2022 (Anticipated)
Study Completion Date
December 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Al-Quds University
Collaborators
Assiut University, Tanta University, European Institute of Oncology

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
Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Investigators will compare them depending on several factors such as; cost effectiveness, hospital stay, duration of putting the drain and more, reinsertion of the chest tube and others.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax and Air Leak, Pneumothorax, Pleura Injury, Pleural Effusion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clamping
Arm Type
Experimental
Arm Description
This arm will undergo chest drain clamping after a certain criteria has been met. Four hours post clamping a chest x-ray will be made, and the presence of pneumothorax will be assessed. The chest drain will be removed only in the absence of pneumothorax, if pneumothorax persists patients will stay attached to the underwater seal
Arm Title
Urine bag
Arm Type
Active Comparator
Arm Description
The second arm will be attached to a urine bag, and bag inflation will be measured after a certain criteria has been met. bag inflation will be assessed four hours after its attachment. Bag inflation indicates the persistence of an air leak, thus the absence of bag inflation indicates the removal of the chest drain
Intervention Type
Other
Intervention Name(s)
Clamping
Intervention Description
Clamping of chest tube
Intervention Type
Other
Intervention Name(s)
Urine bag
Intervention Description
Attachment of a urine bag to chest tube
Primary Outcome Measure Information:
Title
Overall cost
Description
The overall cost of the patient's hospital stay
Time Frame
5 to 6 days
Secondary Outcome Measure Information:
Title
Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag
Description
An important side effect to be studied
Time Frame
up to 5 days
Title
total number of days with chest drain inserted
Description
Number of days chest drain remained inserted
Time Frame
up to 5 days
Title
Number of chest x-rays
Description
Total number of chest x-rays
Time Frame
up to 5 days
Title
Number of participants that faced other intervention associated side effects
Description
Subcutaneous emphysema, tension pneumothorax and others
Time Frame
up to 5 days
Title
Number of participants with chest tube re-insertion
Description
An important side effect
Time Frame
up to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: post lung resection patients (via Uniportal VATS only) Over the age of 18 indicated chest tube Exclusion Criteria: Under the age of 18
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Firas Abuakar, MD
Phone
052220068
Ext
+972
Email
firasabuakar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rami Alaraj, MD candidate
Phone
0598488897
Ext
+970
Email
ra.alaraj@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Firas Abuakar, MD
Organizational Affiliation
Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, Palestine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osama Darras, MD candidate
Organizational Affiliation
Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hadeel Abedalhameed, MD candidate
Organizational Affiliation
Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rami Alaraj, MD candidate
Organizational Affiliation
Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rania Attiyeh, MD candidate
Organizational Affiliation
Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine
Official's Role
Study Chair
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hussein Elkhayat, MD
Email
dr_khayat@hotmail.com
Facility Name
Tanta University
City
Tanta
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Elkholy, MD
Email
ahmed.elkholy@med.tanta.edu.eg
Facility Name
European Institute of Oncology
City
Milan
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Bertolaccini, MD
Email
luca.bertolaccini@gmail.com
Facility Name
Makassed Hospital
City
Jérusalem-Est
Country
Palestinian Territory, occupied
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami Alaraj, MD Candidate
Phone
0598488897
Ext
970
Email
ra.alaraj@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Urine Bag Usage Versus Chest Drain Clamping After Lung Resection Surgeries

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