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

Not Applicable

Completed

• Conditions: Pneumothorax; Chest Tube; Pleural Diseases
• Interventions: Procedure: Non Clampling; Procedure: Clamping

• Registration Number: NCT05243316
• Lead Sponsor: National Institute of Respiratory Diseases, Mexico

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-12-22
• Study First Submitted: 2022-01-31
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-17
• Primary Completion: 2023-03-31
• Study Completion: 2023-04-15
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without clamping of the chest tube	Non Clampling	Patients will have chest tube removed immediately
Patients with clamping of the chest tube	Clamping	Patients with 6hour clamping prior to removal

Primary Outcome Measures

Name	Time	Method
Incidence of pneumothorax after chest tube removal with chest tube clamping	After 24 hours of procedure	Cases of pneumothorax after chest tube removal despite clamping
Incidence of pneumothorax after chest tube removal without chest tube clamping	After 24 hours of procedure	Cases of pneumothorax after chest tube removal despite clamping

Secondary Outcome Measures

Name	Time	Method
Hospital days of stay	Through study completion, an average of 1 month	Hospital days of stay

Trial Locations

Locations (1)

National Institute of Respiratory Diseases; 🇲🇽 Mexico City, Mexico