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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04673084
Other study ID # Negative pleural suction
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date December 1, 2022

Study information

Verified date March 2021
Source Assiut University
Contact Yahia Alassal, 493474
Phone 0201066580715
Email yayaalassal94@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 1, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Device:
negative pleural suction
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Decrease duration of hospital stay. We can measure this by:
Amount and duration of airleak in chest tube.
baseline
See also
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Completed NCT01864577 - Negative Pleural Suction for Tube Thoracostomy in Patients With Chest Trauma N/A