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OpenTrials
Completed

NCT Number: NCT05243316

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

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.

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Key information

Conditions

Pneumothorax Chest Tube Pleural Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Respiratory Diseases

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Non Clampling

Procedure

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Hospital days of stay

    Time frame: Through study completion, an average of 1 month

    Hospital days of stay

Sponsors and collaborators

Lead sponsor

National Institute of Respiratory Diseases, Mexico

Other Gov

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2022
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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