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

NCT05243316 | Completed

• 1 other identifier: C58-21
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumothorax; Chest Tube; Pleural Diseases

Keywords

Chest tube; Pneumothorax; Pleural Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Hospital days of stay

  Through study completion, an average of 1 month

Study Arms (2)

Patients with clamping of the chest tube

ACTIVE COMPARATOR

Patients with 6hour clamping prior to removal

Procedure: Clamping

Patients without clamping of the chest tube

SHAM COMPARATOR

Patients will have chest tube removed immediately

Procedure: Non Clampling

Interventions

Clamping PROCEDURE

There will be a randomized selection of patients who will have a clamping of the chest tube 6 hours prior to chest tube removal.

Patients with clamping of the chest tube

Non Clampling PROCEDURE

There will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal.

Patients without clamping of the chest tube

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

National Institute of Respiratory Diseases

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Pneumothorax; Pleural Diseases

Interventions

Constriction

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Sebastian Rodriguez, Doctor

  Instituto Nacional de Enfermedades Respiratorias

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomizing will be masked, as well as data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 17, 2022
• Study Start: December 22, 2021
• Primary Completion: March 31, 2023
• Study Completion: April 15, 2023
• Last Updated: May 31, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Once completed for one year
• Access Criteria: Free access

Locations

ME (1)