Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions
Phase: NA
Conditions: Hemothorax, Hemopneumothorax; Traumatic, Empyema, Chest Tube Size
Sponsor: Wake Forest University Health Sciences

Prospective Evaluation of Chest Tube Size and Maximum Barrier Precautions                                                    
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CLINICAL STUDY PROTOCOL 
 
 
PROSPECTIVE EVALUATION OF CHEST TUBE 
SIZE AND MAXIMUM BARRIER PRECAUTIONS 
 
 
Protocol Number: 
04-17-06 
National Clinical Trial Identified Number: NCT03167723 
Principal Investigator: 
 
Bradley W. Thomas, MD, FACS 
Department of Surgery 
Carolinas Medical Center 
1000 Blythe Boulevard 
Charlotte, NC 28203 
Telephone: 704-355-1311 
Fax:  704.355.5619  
Bradley.Thomas@carolinashealthcare.org 
 
Sub Investigators: 
 
Rita Brintzenhoff, MD 
A. Britt Christmas, MD 
Kyle Cunningham, MD 
Susan Evans, MD 
John Green, MD 
Toan Huynh, MD 
David Jacobs, MD 
Cindy Lauer, MD 
William Miles, MD 
Alvin Perry, MD 
Gaurav Sachdev, MD 
Rathna Shenoy, MD 
Ronald Sing, DO 
Independent Safety Monitor 
 
Michael Thomason, MD 
 
Quality Assessment Nurse 
 
Lori Gottlieb RN, BSN 
 
Research Staff: 
 
Julia Raddatz, MS 
Michael L. Davis 
Randal Johnston 
Michael Nahouraii 
Leslie Sealey, MBBS 
 
Protocol Version: 
2.0 
Protocol Date: 
29 August 2017 

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Table of Contents 
Abbreviations ............................................................................................................... 3 
Statement of Compliance ........................................................................................... 5 
1 Protocol Summary.................................................................................................... 6 
1.1 Synopsis ............................................................................................................. 6 
1.2 Schema ............................................................................................................. 10 
1.3 Schedule of Activities (SoA) ........................................................................ 11 
2 Introduction ............................................................................................................ 13 
2.1 background....................................................................................................... 13 
2.2 Study rationale ................................................................................................ 13 
2.3 Risk/Benefit Assessment ............................................................................... 14 
2.3.1 Known Potential Risks ........................................................................... 14 
2.3.2 Known Potential Benefits ...................................................................... 14 
2.3.3 Assessment of Potential Risks and Benefits ....................................... 14 
3 Objectives and Endpoints ..................................................................................... 15 
4 Study Design ........................................................................................................... 17 
4.1 Overall Design ................................................................................................ 17 
4.2 Scientific Rationale for Study Design......................................................... 18 
4.3 End of Study Definition ................................................................................ 18 
5 Study Population .................................................................................................... 19 
5.1 Inclusion Criteria ............................................................................................ 19 
5.2 Exclusion Criteria ........................................................................................... 19 
5.3 Screen Failures ................................................................................................ 20 
5.4 Strategies for Recruitment and Retention .................................................. 20 
6 Study Intervention ................................................................................................. 21 
6.1 Study Intervention(s) Administration ......................................................... 21 
6.2 Index Hospitalization review ........................................................................ 21 
6.3 THREE (3) MONTH Follow-Up (dAY 90±14) .......................................... 22 
6.4 Measures to Minimize Bias: Randomization and Blinding ..................... 22 
6.5 Study Intervention Compliance ...................... Error! Bookmark not defined. 
6.6 Concomitant Therapy ..................................................................................... 22 
7 Study Intervention Discontinuation and Participant 
Discontinuation/Withdrawal .................................................................................... 23 
7.1 Discontinuation of Study Intervention ........................................................ 23 
7.2 Participant Discontinuation/Withdrawal from the Study ......................... 23 
7.3 Lost to Follow-Up .......................................................................................... 23 
8 Study Assessments and Procedures .................................................................... 24 
8.1 Efficacy Assessments ..................................................................................... 24 
8.2 Safety and Other Assessments ...................................................................... 24 
8.3 Adverse Events and Serious Adverse Events ............................................. 25 
8.3.1 Definition of Adverse Events (AE) ...................................................... 25 
8.3.2 Definition of Serious Adverse Events (SAE) ..................................... 25 
8.3.3 Severity of Event ..................................................................................... 25 
8.3.4 Relationship to Study Intervention ....................................................... 26 
8.3.5 Expectedness ............................................................................................ 26 

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8.3.6 Time Period and Frequency for Event Assessment and Follow-Up 27 
8.3.7 Serious Adverse Event Reporting ......................................................... 27 
9 Statistical Considerations ..................................................................................... 28 
9.1 Statistical Hypotheses .................................................................................... 28 
9.2 Sample Size Determination ........................................................................... 29 
9.3 Populations for Analyses ............................................................................... 29 
9.4 Statistical Analyses ........................................................................................ 29 
9.4.1 General Approach .................................................................................... 29 
9.4.2 Analysis of the Primary Efficacy Endpoint(s) .................................... 30 
9.4.3 Analysis of the Secondary Endpoint(s) ............................................... 30 
9.4.4 Safety Analyses ......................................... Error! Bookmark not defined. 
9.4.5 Baseline Descriptive Statistics ................ Error! Bookmark not defined. 
9.4.6 Planned Interim Analyses ...................................................................... 30 
9.4.7 Sub-Group Analyses ................................. Error! Bookmark not defined. 
9.4.8 Tabulation of Individual Participant Data ........... Error! Bookmark not 
defined. 
9.4.9 Exploratory Analyses ................................ Error! Bookmark not defined. 
10 Supporting Documentation and Operational Considerations ....................... 31 
10.1 Regulatory, Ethical, and Study Oversight Considerations .................... 31 
10.1.1 Informed Consent Process ................................................................... 31 
10.1.2 Study Discontinuation and Closure .................................................... 32 
10.1.3 Confidentiality and Privacy ................................................................. 32 
10.1.4 Key Roles and Study Governance ...................................................... 32 
10.1.5 Quality Assurance and Quality Control ............................................. 33 
10.1.6 Data Handling and Record Keeping ................................................... 33 
10.1.7 Protocol Deviations .............................................................................. 33 
10.1.8 Conflict of Interest Policy ................................................................... 33 
10.2 Protocol Amendment History ....................... Error! Bookmark not defined. 
11 References ............................................................................................................. 34 
12 APPENDICES ...................................................................................................... 35 
12.1 Appendix A: Trauma Practice Guideline .................................................. 35 
 
 
 
 

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ABBREVIATIONS 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MedDRA Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 

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NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 

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STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Conference on 
Harmonisation Good Clinical Practice (ICH GCP) and the following: 
  
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical 
studies (45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, 
and/or 21 CFR Part 812) 
  
The investigators and clinical trial site staff who are responsible for the conduct, 
management, or oversight of this clinical trial have completed Human Subjects Protection 
and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant 
materials will be submitted to the Institutional Review Board (IRB) for review and 
approval.  Approval of both the protocol and the consent form must be obtained before 
any participant is enrolled.  Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study.  In addition, all 
changes to the consent form will be IRB-approved; a determination will be made 
regarding whether a new consent needs to be obtained from participants who provided 
consent, using a previously approved consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
 
Title: 
Prospective Randomized Evaluation of 14F Thal Tube vs 28 French 
Chest Tube for Hemothorax and Use of Maximum Barrier Precautions 
Phase: 
 Recruiting 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
  
Carolinas Medical Center 
1000 Blythe Blvd, Charlotte, NC 28203 
Study Description: 
Traumatic hemothorax and hemopneumothorax are common diagnoses 
which are typically treated by placement of a chest tube. A retrospective 
review has previously shown equivalence between 14 Fr chest tubes and 
32 – 40 Fr chest tubes for the non-emergent drainage of hemothorax; 
however, this study was not randomized. We seek to perform a 
prospective randomized trial that is adequately powered comparing 
efficacy of 14 Fr thal tubes to 28 Fr chest tubes for non-emergent 
drainage of hemothorax and hemopneumothorax. Additionally, we will 
employ maximal barrier precautions for all chest tube insertions and 
compare empyema rates to our historical controls for patients with 
hemothorax, hemopneumothorax, and pneumothorax. 
Study Population: 
Patients aged 18 and older diagnosed with a traumatic pneumothorax, 
hemothorax or hemopneumothorax that require non-emergent 
placement of a thoracostomy tube as part of their care.  
Aims: 
Aim 1: Determine the safety and efficacy non-inferiority between small 
bore (14 Fr) and large bore (28 Fr) in the drainage of traumatic 
hemothorax and hemopneumothorax  
Aim 2: Determine the incidence of empyema in the setting of traumatic 
pneumothorax, hemothorax and hemopneumothorax with the addition 
of maximum barrier precautions 
 [ Time Frame: 90 days] 
Study Hypothesis 
Aim 1: The investigators hypothesize that there is non-inferiority in 
safety and efficacy between the different chest tube sizes 
Aim 2: Maximum barrier precautions associated with a decrease in 
empyema rate.  
 

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Number of Patients 
Aim 1: With a sample size of n=126 per group, we will have 80% 
power to detect a non-inferiority margin difference between the group 
rates of 8% (allowing up to a 15% rate of drainage failure in the small 
14 tube size group and approximately 7% in the large 28 tube size 
group; α=0.05). 
 
Aim 2: With assumptions of empyema rate is 5% in the retrospective 
group and 2% in the prospective group, 586 patients in each group are 
needed to achieve a power of 0.8 with α=0.05. To account for potential 
attrition, we will inflate the number of patients by 10% resulting in a 
total of 645 patients in the retrospective group and 645 patients in the 
prospective group. 
Inclusion Criteria 
1. 
The patient is admitted to the trauma service. 
2. 
The patient has a pneumothorax, hemothorax and/or 
hemopneumothorax, requiring thoracostomy tube placement. 
3. 
Thoracostomy tube placement is able to be performed or 
witnessed by an investigator listed on the study. 
4. 
The patient has not had a chest tube in the past year. 
5. 
The patient is >18 years of age. 
6. 
In the event the patient is decisionally impaired, consent will be 
obtained from the individual’s legally authorized representative 
(LAR) or from the individual’s healthcare power of attorney 
(HPA). 
7. 
In the instance of reversible impairment, initial consent would be 
obtained from the LAR/HPA and the patient will be approached for 
consent once he/she is deemed mentally competent by the care 
provider. 
 
Exclusion Criteria 
1. The patient is incarcerated 
2. The patient is known to be pregnant 
3. The patient is hemodynamically unstable, requiring emergent 
chest tube placement (in <10 minutes from evaluation).  
4. The patient will have more than one chest tube placed at the time 
of enrollment.  
 

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Outcome measures 
Aim I  
Primary outcome: 
• Retained hemothorax requiring an additional intervention, either 
video-assisted thoracoscopic surgery (VATS) or additional 
thoracostomy tube placement. 
Secondary outcome:  
• Duration of chest tube placement [ Time Frame: 90 days ] 
• Length of hospitalization 
• Subjective pain [ Time Frame: 5 minutes pre- and post-
insertion], Assessed with 0-10 numeric pain rating scale 
• Hemodynamic stability post-insertion (determined by vital signs: 
temperature, heart rate, blood pressure, oxygen saturation) 
• Initial drainage from chest tube at 5 minutes [ Time Frame: 5 
minutes ] 
• Tube specific complications: Air leak, tube malposition, & tube 
migration [ Time Frame: 90 days ] 
• Time to radiographic resolution of 
pneumothorax/hemothorax/hemopneumothorax [ Time Frame: 90 
days ] 
• Recurrent pneumothorax/hemothorax/hemopneumothorax after 
tube removal 
• Readmission for chest tube related complications [Time Frame: 90 
days]  
 
Aim II 
• Empyema rates in traumatic pneumothorax, hemothorax, and 
hemopneumothorax 
 
Description of Study 
Intervention: 
 Placement of 14 Fr Thal tube or 28 Fr Chest Tube for 
Hemopneumothorax.  
Study Duration: 
 2 Years 
Randomization 
Permuted block randomization with random block sizes to allocate 
patients in a 1:1 allocation to the 14 or 28 tube sizes. The randomization 
lists will be generated using SAS Enterprise Guide version 6.1. All 
study staff collecting and recording data for the trial will be masked to 
the tube size that was used during the procedure. 

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Statistical Analysis 
Data Management: 
All prospectively collected subject data will be recorded in Research 
Electronic Data Capture application (REDCap) software, collecting 
insertion specific data including use of a thyroid drape, use of hand 
scrubbing, gown, mask, sterile gloves, and surgical cap. The chest tube 
indication will be collected in the REDCap generated survey. The data 
will be entered into the electronic database within 3 business days of the 
enrollment or follow-up visit. 
 
Statistical procedures for Analysis: 
All analyses for this randomized trial will follow the intention to treat 
principle with an additional per protocol analysis given the non-
inferiority hypothesis. We will first compare the baseline characteristics 
of the patients by group to assess for statistically significant or clinically 
meaningful imbalances. If either exists, these factors will be taken into 
account in sensitivity analyses for the primary and secondary outcomes.  
The rates of failure of drainage (primary outcome) will be estimated as 
proportions and compared between the two groups using a Chi-square 
test corrected for the non-inferiority hypothesis. We will present the 
findings using the difference in the proportions (rate in small group –
rate in large group) and corresponding 95% upper confidence limit.  
 
Length of stay will be compared using Poisson regression with a main 
effect of group. Post insertion pain and vital signs will be compared 
using analysis of covariance controlling for pre-procedural pain and 
vital signs, respectively, with categorical group effect. We will compare 
rates of re-intervention and readmission using chi-square tests for 
independence (or Fisher’s exact tests) and present our findings using 
relative risks and 95% confidence intervals.  
 
An interim analysis for inferiority will be conducted at 50% and 75% 
information accrual. This comparison of the primary outcome, failure of 
drainage, will be compared between the treatment arms with a one-sided 
test for superiority of the 28 tube compared to the 14 (α=0.05). 
 
There will be no missing data for the primary outcome as all 
information will be documented during surgery (no loss to follow up of 
the patient).  
 

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1.2 SCHEMA 
Figure 1: Study Schema 
 
 
 
a Patients who are GCS = 15 will be approached for consent prior to tube insertion. Patients who are GCS 
<15 will be approached (or their Legally Authorized Representative (LAR) will be approached) within 24 
hours of insertion.  If an LAR was used for initial consent, the patient will be consented if and when they 
become GCS = 15 within the follow up period of the study. 

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1.3 SCHEDULE OF ACTIVITIES (SOA) 
 
Table 1: Schedule of Activities 
 
Study Requirement 
Screening 
Treatment Period 
Follow Up 
Day 0 
Day 1 – 
Discharge 
Day 90 
Eligibility Criteria 
X 
 
 
 
Informed Consenta 
X 
 
 
 
Demographics and Baseline 
Injury Characteristics 
X 
 
 
 
Randomization 
 
X 
 
 
Pain Scores 
X 
X 
 
 
Collect Barrier Precautions 
Datab & Antibiotic status 
 
X 
 
 
Thoracostomy Tube Placement 
 
X 
 
 
Vital Signsc 
X 
 (pre-placement) 
X  
(post-placement) 
 
 
Hematologic, Chemistry and 
Coagulation Panel Labs 
X 
 
 
 
Arterial Blood Gas Data (if 
applicable) 
X 
 
 
 
Toxicologyd 
X 
 
 
 
Injury Severity Score 
X 
 
 
 
Measurement of Chest Tube 
Drainage 
 
 
Record Date & Time of 
PTX/HTX or HPTX 
Resolutione 
 
 
 
 
 
 
 
 
a Patients who are GCS = 15 will be approached for consent prior to tube insertion. Patients who are GCS 
<15 will be approached (or their Legally Authorized Representative (LAR) will be approached) within 24 
hours of insertion.  If an LAR was used for initial consent, the patient will be consented if and when they 
become GCS = 15 within the follow up period of the study. 
bBarrier precautions recorded include hand hygiene, cap, gown, gloves, mask and thyroid drape 
cAssessed 5 minutes before and after insertion of thoracostomy tube 
dSerum and urine toxicology will be screened for ethanol, amphetamines, barbiturates, benzodiazepines, 
cocaine, marijuana and opiates only if it is done as standard of care treatment for that patient. 
eRadiologist-confirmed resolution of pneumothorax (PTX), hemothorax (HTX) and hemopneumothorax 
(HPTX)  
 

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Study Requirement 
Screening 
Treatment Period 
Follow Up 
Day 0 
Day 1 – Discharge 
Day 90 
Collect Data on Thoracostomy 
Tube Misplacement, Air Leak, 
& Migration   
 
 
Collect Data on Additional 
Thoracostomy Tubes  
 
 
Assess for Empyema and 
Fibrothorax 
 
 
Collect Operative 
Interventions dataf 
 
 
Record Critical Care and 
Hospital Stay Parametersg 
 
 
 
X 
Survival 
 
 
 
X 
Hospital Readmissions 
 
 
 
X 
Adverse Events/ Serious 
Adverse Events 
 
 
 
 
 
fRefers to video-assisted thoracoscopic surgery (VATS), thoracotomy or thoracostomy tube replacement 
gHospital length of stay (days), ICU stay (days), Mechanical ventilation days 

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2 INTRODUCTION 
2.1 BACKGROUND 
  
Trauma is the leading cause of death for Americans ages 1-44 and a major cause of 
morbidity and mortality worldwide.1 Tube thoracostomy for drainage of blood and/or air 
in the thoracic cavity is a common procedure for patients sustaining both blunt and 
penetrating thoracic trauma. Within the last ten years, smaller bore chest tubes (≤20 Fr) 
are being used with increasing frequency to treat these patients.2 Increasing evidence 
continues to show less pain and similar efficacy of the small-bore tubes3,4. Presently, size 
14 Fr catheters are routinely used for pneumothorax and occasionally used for 
hemothorax. Kulvatunyou et al demonstrated no difference in efficacy between small and 
large bore (>20 Fr) chest tube size for the treatment of hemothorax. However, the study 
sample was small and usage of the small-bore catheters was selective. Data regarding 
complications of tube placement and removal, duration of thoracostomy placement, and 
complications from different tube sizes particularly in the setting of hemothorax is still 
lacking 3,4. 
 
Catheter related bloodstream infections have been successfully reduced using a bundle 
including maximal barrier precautions6. Literature regarding empyema rates and the use 
of maximum barrier precautions during thoracostomy tube insertion remains scarce. A 
well designed prospective study has yet to be developed to properly address the chest 
tube size in the setting of traumatic hemothorax/hemopneumothorax or empyema rates 
with the use of maximum barrier precautions  
 
 
2.2 STUDY RATIONALE  
 
Currently, there are no specific guidelines regarding the optimal chest tube size for the 
treatment of traumatic hemothorax or hemopneumothorax. The efficacy and safety of 
large bore tubes for pleural drainage is well documented and is considered standard 
practice7. While a randomized study comparing small vs. large bore chest tubes for 
pneumothorax has been performed the sample size was small and hemothorax was 
excluded8. The investigators have designed a large randomized clinical trial to address 
the limitations of the data regarding thoracostomy tube size in the treatment of traumatic 
hemothorax and hemopneumothorax. The investigators hypothesize that there is safety 
and efficacy non-inferiority between the different chest tube sizes (Aim 1). 

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In our previous retrospective study, we saw a decrease in empyema rates with 14 Fr 
catheters (small bore) for pneumothorax where the use of a large drape is standard of care 
for barrier protection. This prospective study, also seeks to determine the efficacy of the 
addition of maximal barrier precautions in the prevention of empyema for patients with 
hemothorax and/or pneumothorax (Aim 2).  
 
2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
Some risks from the insertion procedure are: 
• 
Bleeding or infection where the tube is inserted 
• 
Improper placement of the tube (into the tissues, abdomen, or too far in the chest) 
• 
Injury to the lung 
• 
Injury to organs near the tube, such as the spleen, liver, stomach, heart, or 
diaphragm 
• 
Infection 
2.3.2 KNOWN POTENTIAL BENEFITS 
  
• 
Drainage of blood, fluid, or air from around lungs, heart, or esophagus. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
  
Those patients randomized to 14 Fr. Chest tube insertion may experience less pain, but 
also may be subject to a higher retained hemothorax rate. No additional risks are being 
subjected to the patient as tube thoracostomy is standard of care and both devices are 
FDA approved for drainage of fluid.  

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
 
Primary 
Aim I: Determine the safety and efficacy 
non-inferiority between small bore (14 
Fr) and large bore (28 Fr) in the drainage 
of traumatic hemothorax and 
hemopneumothorax  
Endpoint I: Retained hemothorax requiring an 
additional intervention, either video-assisted 
thoracoscopic surgery (VATS) or additional 
thoracostomy tube placement. 
 
Secondary  
Endpoint II: Duration of chest tube placement 
Endpoint III: Initial drainage from chest tube 
at 5 minutes 
Endpoint IV: Length of hospitalization 
Endpoint V: Subjective pain score (pre- and 
post-insertion recorded within 5 minutes of 
insertion). Assessed with 0 -10 numerical pain 
scale 
Endpoint VI: Hemodynamic stability post-
insertion (determined by vital signs: 
temperature, heart rate, blood pressure, oxygen 
saturation) 
Endpoint VII: Time to radiographic resolution 
of pneumothorax, hemothorax, 
hemopneumothorax 
Endpoint VIII: Tube specific complications: 
Air leak, tube malposition, & tube migration 
 
Endpoint IX: Recurrent 
pneumothorax/hemothorax/hemopneumothorax 
after tube removal 
Endpoint X: Readmission to hospital for a 
chest tube related complication 

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OBJECTIVES 
ENDPOINTS 
 
 
Aim II: Determine the incidence of 
empyema in the setting of traumatic 
pneumothorax, hemothorax, and 
hemopneumothorax with the addition of 
maximum barrier precautions 
Endpoint Ia: Empyema rate  
 

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
  
The proposed study is a single center, prospective, non-inferiority trial evaluating the 
efficacy of small bore (14 Fr) vs large bore thoracostomy tubes in the setting of trauma at 
an American College of Surgeons designated Level I trauma center. Each patient will 
receive a study approved thoracostomy tube as indicated and our standard of care 
thoracostomy tube Practice Guideline will be followed. The study period is from the time 
of enrollment (visit day 0) up to 90 days (±14 days) following the date of thoracostomy 
tube placement. A total of 645 subjects will be prospectively enrolled.  
Aim I will be achieved through a prospective randomized study design which will 
evaluate thoracostomy tubes placed in the setting of traumatic hemothorax or 
hemopneumothorax.  The efficacy of the thoracostomy tube sizes will be determined by 
assessing the participants for retained hemothorax which will be define in this study as 
any residual blood that cannot be drained after 72 hours of thoracostomy as confirmed by 
imaging. A total of 252 subjects will be enrolled and randomized in this study group.  
Aim II will be achieved through a prospective non-randomized controlled study design in 
which maximum barrier precautions will be used during chest tube placement for all 
prospective subjects diagnosed with a traumatic pneumothorax, hemothorax or 
hemopneumothorax. The prospective subjects will be compared to subjects in a 
retrospective analysis in which the use of maximum barrier precautions was not standard.  
Maximal barrier precautions will consist of a thyroid drape, hand hygiene, sterile gown, 
mask, and gloves. The use of sterile technique will be consistent throughout the 
prospective study. This will limit the variability between the two treatment arms and 
allow a more accurate comparison of empyema rates between tube size and sterile 
technique. The use of prophylactic antimicrobial agents will also be collected for these 
subjects. A total of 645 subjects will be enrolled in this study group (inclusive of those 
patients enrolled as part of Aim I).  
All participants will be monitored for their need for operative intervention (e.g. VATS), 
development of empyema, hospital readmission, tube related complications (e.g.  tube 
misplacement, tube migration), and death which occurs between thoracostomy tube 
placement and follow-up.  
   
 

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4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
There is currently not enough evidence in the literature to know which size chest tube is 
best in this patient population, which is a primary purpose of the study. 
 
4.3 END OF STUDY DEFINITION 
The study will be complete once target enrollment has been achieved and all outcomes 
information is available.  
 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
• 
The patient is admitted to the trauma service. 
• 
The patient has a hemothorax and/or or hemopneumothorax, requiring 
thoracostomy tube placement. 
• 
Thoracostomy tube placement is able to be performed or witnessed by an 
investigator listed on the study. 
• 
The patient has not had a chest tube in the past year. 
• 
The patient is >18 years of age. 
• 
In the event the patient is decisionally impaired, consent will be obtained from the 
individual’s legally authorized representative (LAR) or from the individual’s 
healthcare power of attorney (HPA). 
• 
In the instance of reversible impairment, initial consent would be obtained from 
the LAR/HPA and the patient will be approached for consent once he/she is 
deemed mentally competent by the care provider. 
  
5.2 EXCLUSION CRITERIA 
• 
The patient is incarcerated 
• 
The patient is known to be pregnant 
• 
The patient is hemodynamically unstable, requiring emergent chest tube 
placement (in <10 minutes from evaluation).  
• 
The patient will have more than one chest tube placed at the time of enrollment.  
  
 
 

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5.3 SCREEN FAILURES 
 
Screen failure patients for this study are those who choose to withdraw from the study or 
who are discovered to meet exclusion criteria after enrollment.   
 
5.4 STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Subject enrollment will take place at a single American College of Surgeons designated 
Level I trauma center. A partial waiver of authorization will be requested for the purposes 
of pre-screening for enrollment via electronic medical record review. All patients 18 
years of age and older sustaining trauma that requires therapeutic tube thoracostomy will 
be screened for study eligibility by the research staff.  Participants will be approached for 
consent as soon as it has been determined that the patient has met all inclusion criteria 
and no exclusion criteria.   
 
The study design aims to maintain high patient retention throughout the study period. 
Subject retention strategies include limiting study involvement to three months and 
limiting subject follow-up to electronic medical record review supplemented by a single 
telephone call.  

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6 STUDY INTERVENTION 
6.1 STUDY INTERVENTION(S) ADMINISTRATION 
Screened subjects eligible for study participation will have their inclusion/exclusion 
criteria verified by an investigator. The subject will be approached for consent by the 
research staff and enrolled. Subjects with suspected pneumothorax alone will receive 
either a small bore (14 Fr) or large bore (28 Fr) tube chosen based on physician 
preference. Subjects with suspected hemothorax or hemopneumothorax will be 
randomized to receive either a small or large bore chest tube.  
Enrolled subjects will have their thoracostomy tube placement procedure observed and 
verified by an investigator listed on this protocol. The training level of the individual 
performing the procedure will be recorded. Maximum barrier precautions for this study 
will be used during the placement procedure for all prospective subjects. Maximum 
barrier precautions for this study will be defined as the correct use of proper hand 
hygiene, a cap, surgical gown, sterile gloves, mask, and a thyroid drape.  The institutional 
standard of care thoracostomy tube Practice Guidelines will be followed.  
 
 
6.2 INDEX HOSPITALIZATION REVIEW 
At the time of enrollment, baseline demographic and injury characteristics will be 
recorded. Baseline data to be recorded include: 
• Demographics (age, sex) 
• Vital signs (pre- and post-tube insertion) 
• Mechanism of injury (blunt vs penetrating) 
• Radiographic findings (pneumothorax, hemothorax or hemopneumothorax) 
• Initial laboratory values (hematologic panel, chemistry panel, coagulation panel, 
toxicology, blood gases) 
• Calculated injury severity score  
The day of tube insertion will mark study day 0. Subjects will be monitored daily by 
study staff in the form of chart review for the duration of their hospitalization. A daily 
data log will be kept for each patient/ The information to be recorded includes: 
• Volume of hemo/hemopneumothorax drainage 
• Tube misplacement 
• Tube migration 
• Presence of air leak 
• Need for additional thoracostomy tubes 

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• Need for operative intervention (VATS, thoracotomy)  
• Date and time of pneumo/hemo/hemopneumothorax resolution as confirmed by a 
radiologist 
• Date and time of chest tube removal 
• Recurrent pnemo/hemo/hemopneumothorax 
• Development of infection 
 
6.3 THREE (3) MONTH FOLLOW-UP (DAY 90±14) 
 
Each participant will be followed for three months (90 days).  Participants will receive a 
telephone follow-up on day 90 (+/-2 weeks). Information obtained during the call will 
include: survival, adverse events and readmission to any hospital for complications 
related to chest tube placement (e.g. empyema, re-accumulation/recurrent pneumo- or 
hemothorax, fibrothorax).  
 
6.4 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND 
BLINDING 
 
We will use stratified permuted block randomization with random block sizes to allocate 
patients in a 1:1 allocation to the 14 or 28 tube sizes. The randomization lists will be 
generated by a study statistician using SAS Enterprise Guide version 6.1 and stratified by 
location (Emergency Department and Surgical & Trauma ICU). Randomization lists will 
be provided to the study coordinator and another study team member not affiliated with 
clinical care and assessments to place the allocations into number opaque envelopes. 
These envelopes will be pulled sequentially by the surgeon or study team as a patient is 
deemed provisionally eligible for the study preserving allocation concealment. The ID of 
the envelope is recorded in the patient’s research record.               
 
6.5 CONCOMITANT THERAPY 
 All concomitant medications and interventions are permissible during the study. Data on 
concomitant antimicrobial therapy administered at the time of thoracostomy tube 
placement will be collected. Antimicrobial agents include antibacterial, antiviral, 
antifungal, and anti-parasitic medications.  

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7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION 
If the initial thoracostomy tube has inadequate drainage, the primary care team reserves 
the right to replace the tube. The patient will not be removed from the study and this data 
will be collected as an outcome.  
 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE 
STUDY 
Participants will be informed at the time of consent that they are free to withdraw from 
the study at any time and for any reason. They will be assured that their medical care will 
not be affected should they elect to discontinue participation in the study. The date the 
patient has withdrawn from the study will be recorded. 
 
7.3 LOST TO FOLLOW-UP 
 
At Day 90 a telephone call will be made to the participant to assess outcome. Three 
attempts will be made to establish contact. If contact is not achieved, the electronic 
medical record will be the only source used to complete the data set.  

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 EFFICACY ASSESSMENTS 
 
The rates of failure of drainage (primary outcome) will be estimated as proportions and 
compared between the two groups using a Chi-square test corrected for the non-
inferiority hypothesis. The margin of non-inferiority is defined as of 8%. 
 
8.2 SAFETY AND OTHER ASSESSMENTS 
The PI and the study team will meet biweekly to review the study procedures, enrollment 
(screening and randomization), implementation, protocol deviations, data collection, and 
adverse events. The biostatistics team will generate monthly reports for the study team 
which will monitor screening, enrollment, completeness of data for intervention 
implementation and outcomes, adverse events, and protocol deviations. 
 
A medical monitor will determine the course of action necessary to meet safety goals and 
objectives. After the first 20 patients are enrolled and randomized, the study statisticians 
will generate a safety report for medical monitor review. An interim analysis for 
inferiority at 50% and 75% information accrual (see section 9.4.4: Planned Interim 
Analysis) will also be conducted. The medical monitor will recommend stopping if there 
is an increased incidence of procedure related serious complications or deaths in either 
treatment group that is found to be clinically significant. 
 
Safety endpoints assessed by the study team and medical monitor will include: 
• General safety assessments 
o Incidence of unanticipated serious adverse events related to chest tube size  
• Thoracostomy tube related safety events 
o Hemodynamic instability post-insertion  
o Need for additional interventions (VATS, thoracotomy, chest tube 
replacement) 
o Procedure related deaths 
o Empyema  
o Re-accumulation/Recurrent pneumo- or hemothorax 
o Readmission to hospital within 90 days of insertion  
 

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8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
An adverse event (AE) is any untoward or unfavorable medical occurrence in a human 
subject temporally associated with the use of a medical treatment or procedure that may 
or may not be related to the use of the medical treatment or procedures.   
 
In this study, we will not be recording AEs unrelated to thoracostomy tube size, as both 
of the thoracostomy tubes used in this study are being used within their approved 
indications. 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
 
A serious adverse event (SAE) is an AE occurring during any study phase (i.e., treatment, 
follow-up), that results in one or more of the following: 
• Death 
• Life-threatening adverse event 
• Inpatient hospitalization or prolongation of existing hospitalization  
• Persistent or significant incapacity or disruption of the ability to conduct normal 
life functions 
• Congenital anomaly/birth defect 
• An important medical event that may not result in death, be life-threatening, or 
require hospitalization but may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed 
above. 
 
In this study, we will only be reporting SAEs that are determined to be unexpected and 
possibly, probably, or definitely related to the size of the initial thoracostomy tube.  The 
principal investigator will assess all potential adverse events for this criteria. 
 
SAEs will be reported in the manner and timeframe that is outlined in the Chesapeake 
IRB handbook. 
8.3.3 SEVERITY OF EVENT 
 The Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 developed by 
the National Institutes of Health’s National Cancer Institute will be used as a severity 
scale for each AE and SAE. The general descriptions of severity for each adverse event is 
as follows: 
 

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Grade 1: 
Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated 
Grade 2 
Moderate; minimal, local or noninvasive intervention indicated; limiting 
age appropriate instrumental activities of daily living 
Grade 3 
Severe or medically significant but not immediately life threatening 
hospitalization or prolongation of hospitalization indicated; disabling; 
limiting self-care activities of daily living 
Grade 4 
Life threatening consequences; urgent intervention indicated 
Grade 5 
Death related to AE 
 
 
8.3.4 RELATIONSHIP TO STUDY INTERVENTION 
The principle investigator will assess the relationship of an adverse event to the 
thoracostomy tube insertion procedure or tube size will be the according to the following 
definitions: 
 
Unrelated 
There is no evidence of any causal relationship 
Possibly related There is some evidence to suggest a causal relationship. However, the 
influence of other factors may have contributed to the event.  
Probably 
related 
There is evidence to suggest a causal relationship and the influence of 
other factors is unlikely 
Definitely 
related 
There is clear evidence to suggest a causal relationship and other 
possible contributing factors can be ruled out.  
 
8.3.5 EXPECTEDNESS 
The principle investigator is responsible for assessing the expectedness of an event.  
Expected safety events of interest for this study include: misplacement of tube, tube 
migration, death during insertion procedure, air leak, empyema, need for additional 
interventions (VATS, thoracotomy, chest tube replacement), catheter related blood 
stream infection and thoracostomy tube related hospital readmission.  For the purposes of 
this study, deaths will be captured as clinical outcomes and do not need to be reported as 
SAEs unless determined by the principle investigator to be related to chest tube size.  
 
All unanticipated problems that meet study definition will be reported to the IRB. An 
unanticipated problem is defined as “any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence 

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in the investigational plan or application (including a supplementary plan or application), 
or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects” (21CFR 812.3(s)). 
 
8.3.6 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND 
FOLLOW-UP 
  
Participants will be assessed for AEs and SAEs daily during hospitalization and at 90-day 
follow-up.  
8.3.7 SERIOUS ADVERSE EVENT REPORTING 
 
Participants will be monitored for serious adverse events from the moment of 
randomization through 90 days post tube insertion. Due to their mechanism of injury and 
high trauma burden, participants are expected to have significant trauma related 
complications. AEs or SAEs determined to be unrelated to study procedure or tube size 
will not be reported to the IRB. Submission of any serious adverse event will not occur 
until relatedness of the event has been determined.  

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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
Primary Efficacy Endpoint(s): 
• 
Aim I 
o Retained hemothorax requiring an additional intervention, either video-
assisted thoracoscopic surgery (VATS) or additional thoracostomy tube 
placement. 
• 
Aim II 
o Empyema rates in traumatic pneumothorax, hemothorax, and 
hemopneumothorax 
  
Secondary Efficacy Endpoint(s): 
• 
Aim I 
o Duration of chest tube placement 
o Initial drainage from chest tube at 5 minutes 
o Length of hospitalization 
o Subjective pain score (pre- and post-insertion recorded within 5 minutes of 
insertion). Assessed with 0 -10 numerical pain scale 
o Hemodynamic stability post-insertion (determined by vital signs: 
temperature, heart rate, blood pressure, oxygen saturation) 
o Time to radiographic resolution of pneumothorax, hemothorax, 
hemopneumothorax 
o Tube specific complications: Air leak, tube malposition, & tube migration 
o Recurrent pneumothorax/hemothorax/hemopneumothorax after tube 
removal 
o Readmission to hospital for a chest tube related complication 
 
 
 
 
 
 

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9.2 SAMPLE SIZE DETERMINATION 
Aim I 
This study is a non-inferiority randomized controlled trial comparing placement of 14 
French vs. 28 French chest tubes for hemothorax and hemopneumothorax. We 
hypothesize the rate of drainage failure to be approximately 7% in the large 28 tube size 
group. With a sample size of n=126 per group, we will have 80% power to detect a non-
inferiority margin difference between the group rates of 8% (allowing up to a 15% rate of 
drainage failure in the small 14 tube size group; α=0.05). In our prior study, we saw a 
20% vs 6.7% difference in needing additional procedures for pneumothorax with small vs 
large catheters but these numbers are based on draining air not blood. Sample size 
analyses were conducted in PASS 139.  
 
Aim II 
Calculations of sample size were based on two-group comparisons of empyema rates. 
With assumptions of empyema rate is 5% in the retrospective group and 2% in the 
prospective group, 586 patients in each group are needed to achieve a power of 0.8 with 
α=0.05. To account for potential attrition, we will inflate the number of patients by 10% 
resulting in a total of 645 patients in the retrospective group and 645 patients in the 
prospective group. The sample size was calculated by using the PASS 1510.  
9.3 POPULATIONS FOR ANALYSES 
The study population will consist of patients aged 18 and older diagnosed with a 
traumatic pneumothorax, hemothorax or hemopneumothorax that require non-emergent 
placement of a thoracostomy tube as part of their care. 
 
9.4 STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
  
All analyses for this randomized trial will follow the intention to treat principle with an 
additional per protocol analysis given the non-inferiority hypothesis. We will first 
compare the baseline characteristics of the patients by group to assess for statistically 
significant or clinically meaningful imbalances. If either exists, these factors will be taken 
into account in sensitivity analyses for the primary and secondary outcomes. 
 
 

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9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
  
The rates of failure of drainage (primary outcome) will be estimated as proportions and 
compared between the two groups using a Chi-square test corrected for the non-
inferiority hypothesis. We will present the findings using the difference in the proportions 
(rate in small group –rate in large group) and corresponding 95% upper confidence limit. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
  
Length of stay will be compared using Poisson regression with a main effect of group. 
Post insertion pain and vital signs will be compared using analysis of covariance 
controlling for pre-procedural pain and vital signs, respectively, with categorical group 
effect. We will compare rates of re-intervention and readmission using chi-square tests 
for independence (or Fisher’s exact tests) and present our findings using relative risks and 
95% confidence intervals. 
 
9.4.4 PLANNED INTERIM ANALYSES 
  
An interim analysis for inferiority will be conducted at 50% and 75% information 
accrual. This comparison of the primary outcome, failure of drainage, will be compared 
between the treatment arms with a one-sided test for superiority of the 28 tube compared 
to the 14 (α=0.05). 
 
 
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT 
CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
  
The IRB approved informed consent form (ICF) will adhere to ICH GCP guidelines and 
comply with the United States Code of Federal Regulations as detailed in 21 CFR §50.25 
and the Declaration of Helsinki.  
Once eligibility has been confirmed, an investigator/research coordinator will approach 
each patient or legally authorized representative (LAR) to explain the nature of the study, 
its purpose, expected duration, alternative forms of therapy available, benefits and risks 
of study participation. Patients who are GCS = 15 will be approached prior to 
thoracostomy tube insertion for study consent. Patients with GCS <15 will either be 
consented by LAR or approached for self-consent if mentation normalizes within 24 
hours of tube insertion. Where consent has been obtained from a LAR; the patient will be 
approached for consent if the investigator later deems the patient GCS = 15 during the 
study period.   
It is expected that most patients/ LARs will be approached in either the emergency room 
or intensive care unit for consent. After this explanation and before enrollment, the 
patient or authorized legal representative will be given ample time and opportunity to 
read the consent form. Patients/LARs who choose to participate will voluntarily sign and 
date the form in the presence of the investigator/research coordinator. 
It will be pointed out to the patient/LAR that they can refuse to participate in the study or 
withdraw from the study at any time without prejudice to further care and treatment.  
The patient/LAR will be given a copy of the signed and dated informed consent form. 
The acquisition of informed consent will be documented in the patient’s medical records.  
Patients/LARs will be informed of any significant new finding which arises during the 
course of study participation that may affect their decision to continue participation.  
 
 
 

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10.1.2 STUDY DISCONTINUATION AND CLOSURE 
  
The investigator reserves the right to terminate the study at any time. Should this be 
necessary, the investigator will notify the appropriate regulatory authority (ies), and IRB. 
In terminating the study, the investigator will assure that consideration is given to protect 
the interests of the patients.  
 
10.1.3 CONFIDENTIALITY AND PRIVACY 
  
The investigator assures that patients’ anonymity will be strictly maintained and that their 
identities will be protected from unauthorized parties. The Investigator will keep a patient 
identification log showing codes, names, ages and sex for all patients screened and 
enrolled in the study. Identifying patient information will not be shared with parties not 
part of the research team.  
 
10.1.4 KEY ROLES AND STUDY GOVERNANCE 
 
Principle Investigator- The investigator is responsible for ensuring that the clinical study 
is performed in accordance with the protocol, current ICH GCP guidelines, the 
Declaration of Helsinki and applicable institutional regulatory requirements.  
 
Medical Monitor (MM)-   The MM will provide medical guidance and oversee the safety 
aspects of the study.  The MM is responsible for monitoring serious adverse events 
(SAEs) on an ongoing basis to ensure participant safety.  
 
Quality Assessment Nurse -  The quality assessment nurse will review patient enrollment 
weekly and provide a secondary point of review to monitor patients for significant chest 
tube related complications (e.g. ICU re-admissions, hospital re-admissions, re-current 
pneumothoraces/hemothoraces, etc.).  All complications reported by the patient or staff 
will be reported to the quality assessment nurse. 
 
 
 
 
 

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10.1.5 QUALITY ASSURANCE AND QUALITY CONTROL 
  
10.1.6 DATA HANDLING AND RECORD KEEPING 
10.1.6.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
 
Subject data will be collected and entered by authorized research staff in the Research 
Electronic Data Capture application (REDCap) system which is compliant with 21 CFR 
Part 11. This is a secure, web-based system, allowing those with permission to access 
data from any location at any time. The electronic case report forms generated will create 
a secure, computer-generated, time stamped audit trail to record the date and time of 
operator entries and actions that create, modify, or delete electronic records.  
 
10.1.6.2 STUDY RECORDS RETENTION 
  
Paper records for the study will be maintained for a minimum of 3 years after study.  All 
paper records will be will be stored in a central location with restricted access in locked 
file cabinets. Access will only be granted to designated research staff.  
 
10.1.7 PROTOCOL DEVIATIONS 
  
This study will be conducted as described in this protocol except for emergency 
situations in which the protection, safety and wellbeing of the patient requires immediate 
intervention based upon the judgement of the investigator. Protocol deviations will be 
recorded with an explanation as well as actions that were taken to mitigate their effects. 
Deviations that impact the rights, welfare or safety of patients shall promptly be reported 
to the IRB as required.  
 
10.1.8 CONFLICT OF INTEREST POLICY 
 This is an internally funded clinical trial. None of the investigators have received or will 
receive money or other benefits for personal use from this study.  
 
 
 
 

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11 REFERENCES 
1 
Centers for Disease Control and Prevention National Center for Injury Prevention 
and Control (NCIPC). The Burden of Injury and Violence: A Pressing Public Health 
Concern.  Online publication.  Available at: www.cdc.gov/injury.  Accessed 
September 2011. 
2 
Light RW. Pleural controversy: optimal chest tube size for drainage. Respirology. 
2011;16(2): 244-8. 
3 
Fysh ET, Smith NA, Lee YC. Optimal chest drain size: The rise of the small-bore 
pleural catheter. Seminars Respiratory Critical Care Medicine. 2010; 31(6)760-8 
4 
Kulvatunyou N, Joseph B, Friese RS, et al. 14 French pigtail catheters placed by 
surgeons to drain blood on trauma patients: is 14-Fr too small? J Trauma Acute Care 
Surg. 2012; 73(6):1423-27 
5 
Inaba K, Lustenberger T, Recinos G, et al. Does size matter? A prospective analysis 
of 29-32 versus 36-40 French chest tube size in trauma. J Trauma. 2010; 72: 422-427 
6 
Moretti EW, Ofstead CL, Kristy RM, Wetzler HP. Impact of central venous catheter 
type and methods on catheter-related colonization and bacteraemia. J Hosp Infect, 
2005; 61:139–45. 
7 
BET 4: Does size matter? Chest drains in haemothorax following trauma. Emerg Med 
J, 2013; 30 (11): 965-967  
8 
Kulvatunyou N, Erickson L, Vijayasekaran A, et al. Randomized clinical trial of 
pigtail catheter versus chest tube in injured patients with uncomplicated traumatic 
pneumothorax. Br J Surg, 2014; 101: 17-22 
9 
PASS 13 Power Analysis and Sample Size Software (2014). NCSS, LLC. Kaysville, 
Utah, USA, ncss.com/software/pass. 
10 PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, 
Utah, USA, ncss.com/software/pass 
 

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12 APPENDICES 
12.1 APPENDIX A: TRAUMA PRACTICE GUIDELINE 
 
 
 
 
 
This guideline is a suggested approach and is intended to supplement rather than substitute, for 
professional judgment.  The care provider may change this plan depending upon clinical 
circumstances and available resources, but should clearly document in the medical record the 
rationale for doing so.  Failure to comply with this pathway does not represent a breach of the 
standard of care. 
 
I. Purpose: To have a guideline for tube thoracostomy management and simple 
pneumothorax management. 
II. The indications for the placement of a chest tube include: 
a. Hemothorax or pneumothorax by CXR or CT scan. 
b. Prophylactic chest drainage in patients with severe blunt chest trauma requiring 
positive pressure ventilation. 
c. Clinically significant pleural effusions or other pleural collections.  
d. Evidence of subcutaneous air in chest and/or neck. 
III. Chest tube insertion 
a. A 14 F catheter may be used as first line treatment. A large bore catheter (28F or 
greater) may be used according to physician judgment.  
IV. Chest Radiographs 
a. Post insertion CXR for tube placement should be done routinely after insertion. 
b. A routine CXR (PA/Lateral) should be obtained after the chest tube has been 
removed. ANY development of respiratory distress or evidence of patient 
deterioration warrants an immediate STAT CXR.  
c. When placing the patient on water seal from suction, a routine CXR is not 
necessary. 
d. Consideration should be given for obtaining a CXR when placing to water seal for 
any patient who has had a recurrent residual pneumothorax. 
V. An abrupt decrease in chest tube output (>50% decrease compared to prior 24 hours 
output) may indicate that the chest tube is no longer functional.  Consider obtaining 
CXR to rule out significant re‐accumulation of pleural fluid before discontinuing 
chest tube. 
VI. References 
a. BET  4:  Does size matter?  Chest drains in hemothorax following trauma: Table 
4. Emergency Medicine Journal. 2013;30(11):965‐967.  

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