Duration of Chest Tube Suction in Traumatic Pneumothorax

Not Applicable

Withdrawn

• Conditions: Traumatic Pneumothorax
• Interventions: Procedure: Chest tube suction

• Registration Number: NCT04986527
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-08-03
• Study Start: 2021-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-12
• Last Update Posted: 2022-03-29
• Primary Completion: 2023-04-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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• Subjects with chest tubes that are withdrawn or removed unintentionally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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 hours of suction	Chest tube suction	Subjects with chest tubes kept to -20 cmH2O suction for 24 hours prior to water seal
48 hours of suction	Chest tube suction	Subjects with chest tubes kept to -20 cmH2O suction for 48 hours prior to water seal

Primary Outcome Measures

Name	Time	Method
Chest tube dwell time	up to 1 month	Total time that chest tube is in place from insertion to removal

Secondary Outcome Measures

Name	Time	Method
Transfer to ICU	up to 1 week	Number of participants with an unplanned transfer to the intensive care unit
Number of participants with at least one pulmonary complications	up to 1 week	Pulmonary complications are defined as increased oxygen requirements, shortness of breath or unplanned intubations following placement to suction.
Readmission to hospital	30 days	Number of participants readmitted to the hospital within 30 days
Number of participants with reaccumulation of pneumothorax	up to 3 days	After transition to water seal and stopping suction, incidence of reaccumulation of pneumothorax requiring suction or replacement of chest tube.
Median length of stay	Up to 1 year	Median length of stay in the hospital after chest tube placement

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States