NCT04673084

Brief Summary

:The investigators aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of under water seal alone of chest tube in one groups of trauma patients and the effect of both under water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

October 18, 2020

Last Update Submit

March 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Decrease duration of hospital stay.

    We can measure this by: Amount and duration of airleak in chest tube.

    baseline

Interventions

by comparing the effect of water seal alone of chest tube in one groups of trauma patients and the effect of both water seal and suction in other group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

: patients who presented to Trauma Department, Assiut University Hospital and who meet the listed inclusion will be eligible for the study. The charts will be reviewed and eligible patients will be filtered.

You may qualify if:

  • 1-Pneumothorax after penetrating or blunt chest trauma
  • Hemothorax after penetrating or blunt chest trauma
  • Hemopneumothorax after penetrating or blunt chest trauma 4-All patients of all ages and genders are included

You may not qualify if:

  • Anyperson associating with body trauma outside chest.
  • Invasive mechanical ventilation
  • Emergent Surgery (thoracoscopy, open thoracotomy)
  • Chronic pulmonary diseases (COPD, CRPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Muslim M, Bilal A, Salim M, Khan MA, Baseer A, Ahmed M. Tube thorocostomy: management and outcome in patients with penetrating chest trauma. J Ayub Med Coll Abbottabad. 2008 Oct-Dec;20(4):108-11.

    PMID: 19999219BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chest Tube Drainage With Under Water Seal Versus Addition Of Negative Pleural Suction In Chest Trauma Patients

Study Record Dates

First Submitted

October 18, 2020

First Posted

December 17, 2020

Study Start

April 1, 2021

Primary Completion

November 30, 2022

Study Completion

December 1, 2022

Last Updated

March 4, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Overall Goal: We aim to provide trauma patient with the best and most efficient managment options and long-term stability with the least complications by comparing the effect of water seal alone of chest tube in one groups of trauma patients and the effect of both water seal and suction in other group and the benefits of one versus the other in duration of hospital stay and to assess short-term post-traumatic complications ,also to assess effectiveness of adding suction and patient satisfaction.