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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05641779
Other study ID # pigtail drainage
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2022
Est. completion date May 2025

Study information

Verified date November 2022
Source Assiut University
Contact mohamed g gaber, resident
Phone 01067930733
Email mohamedgamalsweed4@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Assessment and evaluation of Pigtail application in drainage of pneumothorax and haemothorax.


Description:

Chest injuries are common following blunt and penetrating trauma. Fewer than 10 per cent of blunt injuries and 15-30 per cent of penetrating injuries require surgical management1. Most can be managed with tube thoracostomy to expand the lung (pneumothorax) or to drain blood (haemothorax)2. Although tube thoracostomy is fairly effective, it can be associated with complications such as mispositioning, malfunction, or injury by insertion through the diaphragm or liver3-5. The standard tube size. Has usuallybeen32-40Fr.Insertion of such a large -calibre tube requires a cut-down technique, can be traumatic, and is often associated with significant pain and discomfort. Pigtail catheters, originally used by cardiologists to drain chronic pericardial effusion6, were later modified and adapted for pleural drainage7. Because of their small size and reduced trauma during placement, patients may experience significantly decreased pain and discomfort. Pigtail catheters are frequently used in the paediatric population8-10, as well as in adult, non-traumatic situations11-17 Pigtail catheters inserted at the bedside have similar efficacy to traditional chest tube.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date May 2025
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - iatrogenic pneumothorax Exclusion Criteria: - Age less than 18 years. - refused to participate. - Unconscious. - spontaneous pneumothorax.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
pigtail
pigtail catheter insertion in chest in the pleural cavity

Locations

Country Name City State
Egypt Assiut University Hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Chang SH, Kang YN, Chiu HY, Chiu YH. A Systematic Review and Meta-Analysis Comparing Pigtail Catheter and Chest Tube as the Initial Treatment for Pneumothorax. Chest. 2018 May;153(5):1201-1212. doi: 10.1016/j.chest.2018.01.048. Epub 2018 Feb 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effective drainage of pleural effusion and pneumothorax Effective drainage of pleural effusion and pneumothorax by using the imaging Rhea's method . techniques (chest x-ray and ultrasound ) By measuring the pneumothorax rim and pleural effusion in centimeters . Sum of interpleural distance Read pneumothorax size from table PA and AP . baseline
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