Back to resultsDuration of Chest Tube Suction in Traumatic Pneumothorax
Primary Purpose
Traumatic Pneumothorax
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chest tube suction
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Pneumothorax
Eligibility Criteria
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- Subjects with chest tubes that are withdrawn or removed unintentionally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.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
24 hours of suction
48 hours of suction
Arm Description
Subjects with chest tubes kept to -20 cmH2O suction for 24 hours prior to water seal
Subjects with chest tubes kept to -20 cmH2O suction for 48 hours prior to water seal
Outcomes
Primary Outcome Measures
Chest tube dwell time
Total time that chest tube is in place from insertion to removal
Secondary Outcome Measures
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.
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.
Readmission to hospital
Number of participants readmitted to the hospital within 30 days
Transfer to ICU
Number of participants with an unplanned transfer to the intensive care unit
Median length of stay
Median length of stay in the hospital after chest tube placement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04986527
Brief Title
Duration of Chest Tube Suction in Traumatic Pneumothorax
Official Title
Chest Tube Management in Traumatic Pneumothorax: Does Duration of Suction Matter
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
study does not have funding
Study Start Date
October 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Pneumothorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
24 hours of suction
Arm Type
Active Comparator
Arm Description
Subjects with chest tubes kept to -20 cmH2O suction for 24 hours prior to water seal
Arm Title
48 hours of suction
Arm Type
Experimental
Arm Description
Subjects with chest tubes kept to -20 cmH2O suction for 48 hours prior to water seal
Intervention Type
Procedure
Intervention Name(s)
Chest tube suction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chest tube dwell time
Description
Total time that chest tube is in place from insertion to removal
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Number of participants with reaccumulation of pneumothorax
Description
After transition to water seal and stopping suction, incidence of reaccumulation of pneumothorax requiring suction or replacement of chest tube.
Time Frame
up to 3 days
Title
Number of participants with at least one pulmonary complications
Description
Pulmonary complications are defined as increased oxygen requirements, shortness of breath or unplanned intubations following placement to suction.
Time Frame
up to 1 week
Title
Readmission to hospital
Description
Number of participants readmitted to the hospital within 30 days
Time Frame
30 days
Title
Transfer to ICU
Description
Number of participants with an unplanned transfer to the intensive care unit
Time Frame
up to 1 week
Title
Median length of stay
Description
Median length of stay in the hospital after chest tube placement
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Duration of Chest Tube Suction in Traumatic Pneumothorax
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