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

May 30, 2023 updated by: National Institute of Respiratory Diseases, Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • National Institute of Respiratory Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with clamping of the chest tube
Patients with 6hour clamping prior to removal
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.
Sham Comparator: Patients without clamping of the chest tube
Patients will have chest tube removed immediately
Procedure: Non Clampling
There will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pneumothorax after chest tube removal with chest tube clamping
Time Frame: After 24 hours of procedure
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
Time Frame: After 24 hours of procedure
Cases of pneumothorax after chest tube removal despite clamping
After 24 hours of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital days of stay
Time Frame: Through study completion, an average of 1 month
Hospital days of stay
Through study completion, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • Study Director: Sebastian Rodriguez, Doctor, National Institute of Respiratory Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C58-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Database will be available once the protocol is complete

IPD Sharing Time Frame

Once completed for one year

IPD Sharing Access Criteria

Free access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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