Duration of Chest Tube Suction in Traumatic Pneumothorax

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Pneumothorax
• Intervention / Treatment: Procedure: Chest tube suction

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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• Subjects with chest tubes that are withdrawn or removed unintentionally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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 24 hours of suction; Subjects with chest tubes kept to -20 cmH2O suction for 24 hours prior to water seal	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.
Experimental: 48 hours of suction; Subjects with chest tubes kept to -20 cmH2O suction for 48 hours prior to water seal	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest tube dwell time	Total time that chest tube is in place from insertion to removal	up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Readmission to hospital	Number of participants readmitted to the hospital within 30 days	30 days
Transfer to ICU	Number of participants with an unplanned transfer to the intensive care unit	up to 1 week
Median length of stay	Median length of stay in the hospital after chest tube placement	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 22, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: STUDY00005364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No