Under Water Seal Versus Negative Pleural Suction in Chest Trauma Patients

March 3, 2021 updated by: Yahia Abd almonem Sayed, Assiut University

Chest Tube Drainage With Under Water Seal Versus Addition Of Negative Pleural Suction In Chest Trauma Patients

: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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Traumas are the leading cause of death in the first four decades of life and are mostly caused by traffic accidents. Thoracic traumas might lead to severe consequences, even though less than 50% of them required a surgical revision. Thoracic traumas can be divided in blunt or penetrating, according to the presence of open wound in the chest. Blunt traumas are the most frequent type of chest trauma with or without rib fractures that might be associated with haemothorax, pneumothorax or haemopneumothorax that are the most typical lesions or laceration.

Pleural chest tubes are used to reestablish negative intrathoracic pressure after disruption of the pleural space. Chest tube positioning is considered necessary in case of a pleural disruption with pneumothorax; intrapleural bleeding causing haemothorax; or in case of pneumo-haemothorax .

The management of pleural chest tubes with primarily under water seal or added suction is the subject of debate, and the benefits of one versus the other in regards to duration of air leak, amount of time the chest tube is in place, length of hospital stay and incidence of complications are unclear.

All of the previous made us interesting to examine 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, the investigators think that power of suction will give the patient better results with less complications and excellent immediate relief with good quality of life, rapid return to normal life .

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • • 1-Pneumothorax after penetrating or blunt chest trauma

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

Exclusion Criteria:

  • 1-Anyperson associating with body trauma outside chest.

    • 2-Invasive mechanical ventilation
    • 3-Emergent Surgery (thoracoscopy, open thoracotomy)
    • 4-Chronic pulmonary diseases (COPD, CRPD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease duration of hospital stay.
Time Frame: baseline

We can measure this by:

Amount and duration of airleak in chest tube.

baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 18, 2020

First Submitted That Met QC Criteria

December 12, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Negative pleural suction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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