NCT05230420

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
3 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

February 8, 2022

Status Verified

December 1, 2021

Enrollment Period

11 months

First QC Date

December 20, 2021

Last Update Submit

January 27, 2022

Conditions

Pneumothorax and Air LeakPneumothoraxPleura InjuryPleural Effusion

Outcome Measures

Primary Outcomes (1)

  • Overall cost

    The overall cost of the patient's hospital stay

    5 to 6 days

Secondary Outcomes (5)

  • Number of participants with re-accumulation of air after chest tube clamping or attachment to the urine bag

    up to 5 days

  • total number of days with chest drain inserted

    up to 5 days

  • Number of chest x-rays

    up to 5 days

  • Number of participants that faced other intervention associated side effects

    up to 5 days

  • Number of participants with chest tube re-insertion

    up to 5 days

Study Arms (2)

Clamping

EXPERIMENTAL

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

Other: Clamping

Urine bag

ACTIVE COMPARATOR

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

Other: Urine bag

Interventions

ClampingOTHER

Clamping of chest tube

Clamping
Urine bagOTHER

Attachment of a urine bag to chest tube

Urine bag

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Assiut University

Asyut, Egypt

NOT YET RECRUITING

Tanta University

Tanta, Egypt

NOT YET RECRUITING

European Institute of Oncology

Milan, Italy

NOT YET RECRUITING

Makassed Hospital

East Jerusalem, Palestinian Territories

RECRUITING

MeSH Terms

Conditions

PneumothoraxPleural Effusion

Interventions

Constriction

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Firas Abuakar, MD

    Thoracic Surgery Unit, Makassed Islamic Charitable Society Hospital, Jerusalem, Palestine

    PRINCIPAL INVESTIGATOR

  • Osama Darras, MD candidate

    Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

    STUDY CHAIR

  • Hadeel Abedalhameed, MD candidate

    Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

    STUDY CHAIR

  • Rami Alaraj, MD candidate

    Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

    STUDY DIRECTOR

  • Rania Attiyeh, MD candidate

    Medical Research Club, faculty of medicine, Alquds University, Jerusalem, Palestine

    STUDY CHAIR

Central Study Contacts

Firas Abuakar, MD

CONTACT

052220068firasabuakar@gmail.com

Rami Alaraj, MD candidate

CONTACT

0598488897ra.alaraj@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

February 8, 2022

Study Start

January 1, 2022

Primary Completion

November 25, 2022

Study Completion

December 25, 2022

Last Updated

February 8, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)PA(1)IT(1)