Duration of Chest Tube Suction in Traumatic Pneumothorax

Traumatic Pneumothorax Clinical Trial

Official title:

Chest Tube Management in Traumatic Pneumothorax: Does Duration of Suction Matter

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04986527
• Other study ID #: STUDY00005364
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot study is to determine whether chest tube suction duration, 24 hours vs 48 hours, prior to water seal affects outcome and length of stay after placement for traumatic pneumothorax.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Trauma service consult/patient
• Traumatic pneumothorax with chest tube placed within 0-24 hours of presentation and confirmation of adequate position
• Age >18
• Blunt or penetrating mechanism
• Chest tubes sizes 14 to 32Fr
• Chest tubes placed by residents on the trauma surgery service supervised by attending trauma surgeons or placed by the attending surgeon themselves
• Presence of single chest tube in one or both pleural cavities (single unilateral or bilateral tubes)
• Subjects with decision making capacity (DMC) who are able to provide written consent. DMC will be determined by the consenting physician through a teach back mechanism. Subjects must demonstrate understanding of the situation, appreciation of the consequences of their decision, reasoning of their thought process, and be able to communicate their wishes.

Exclusion Criteria:

• Age <18
• Pregnant patients
• Prisoners
• Mechanically ventilated in ICU for more than 24 hours while chest tube in place
• Chest tubes placed as part of, or present during, a thoracic operation
• History of surgery involving pleural cavity ipsilateral to chest tube
• Subjects with more than one chest tube on the ipsilateral side at any time prior to study chest tube removal
• Subjects with chylothorax or empyema
• Subjects with chest tubes that are withdrawn or removed unintentionally
• Subjects with known or suspected bronchial injury
• Subjects with bullous emphysema.

Related Conditions & MeSH terms

• Pneumothorax
• Traumatic Pneumothorax

Intervention

Procedure:
• Chest tube suction
The chest tubes will be inserted using our institutional standard chest tube insertion tray. The chest tubes used will be our institutional standard and will range from 14 to 32Fr in size. After chest tube placement, an Atrium Oasis Dry Suction Water Seal Chest Drain (Getinge USA Sales, LLC) will be used.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest tube dwell time	Total time that chest tube is in place from insertion to removal	up to 1 month
Secondary	Number of participants with reaccumulation of pneumothorax	After transition to water seal and stopping suction, incidence of reaccumulation of pneumothorax requiring suction or replacement of chest tube.	up to 3 days
Secondary	Number of participants with at least one pulmonary complications	Pulmonary complications are defined as increased oxygen requirements, shortness of breath or unplanned intubations following placement to suction.	up to 1 week
Secondary	Readmission to hospital	Number of participants readmitted to the hospital within 30 days	30 days
Secondary	Transfer to ICU	Number of participants with an unplanned transfer to the intensive care unit	up to 1 week
Secondary	Median length of stay	Median length of stay in the hospital after chest tube placement	Up to 1 year