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pigtail: Pigtail Catheter for Drainage of (Pneumothorax/Simple Effusion) is a Effective Procedure

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05641779
Collaborator
(none)
25
Enrollment
1
Location
29
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: pigtail

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
25 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pigtail Catheter for Drainage of (Pneumothorax/Simple Effusion) is a Effective Procedure
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Effective drainage of pleural effusion and pneumothorax [baseline]

    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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • iatrogenic pneumothorax
Exclusion Criteria:

  • Age less than 18 years.

  • refused to participate.

  • Unconscious.

  • spontaneous pneumothorax.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Hospital Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: ali a wahab, profesor, Assiut University
  • Study Director: mahmoud h elnaby, lecturer, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
mohamed gamal gaber, resident, Assiut University
ClinicalTrials.gov Identifier:
NCT05641779
Other Study ID Numbers:
  • pigtail drainage
First Posted:
Dec 8, 2022
Last Update Posted:
Dec 8, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pleural Effusion
Pneumothorax

Study Results

No Results Posted as of Dec 8, 2022