Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology

Pneumothorax Clinical Trial

Official title:

Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243316
• Other study ID #: C58-21
• Status: Completed
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: April 15, 2023

Study information

• Verified date: February 2022
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping. The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.

Description:

Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal). Incidence of 24hour pneumothorax after chest tube removal will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 15, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 16 years and more.
• Patients hospitalized in the National Institute of Respiratory Diseases.
• Patients who had a chest tube placement during their stay at the hospital, by any cause.

Exclusion Criteria:

• Patients who refuse to sign the informed consent and who refuse to participate in the study.
• Patients who die before randomization.
• Patients who gets chest tube removal before being randomized.

Related Conditions & MeSH terms

• Chest Tube
• Pleural Diseases
• Pneumothorax

Intervention

Procedure:
• Clamping
There will be a randomized selection of patients who will have a clamping of the chest tube 6 hours prior to chest tube removal.
• Non Clampling
There will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal.

Locations

Country	Name	City	State
Mexico	National Institute of Respiratory Diseases	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pneumothorax after chest tube removal with chest tube clamping	Cases of pneumothorax after chest tube removal despite clamping	After 24 hours of procedure
Primary	Incidence of pneumothorax after chest tube removal without chest tube clamping	Cases of pneumothorax after chest tube removal despite clamping	After 24 hours of procedure
Secondary	Hospital days of stay	Hospital days of stay	Through study completion, an average of 1 month