Trial Outcomes & Findings for Prospective Evaluation of 14F Thal Tube vs 28 French Chest Tube for Hemothorax and Use of Maximum Barrier Precautions (NCT NCT03167723)
NCT ID: NCT03167723
Last Updated: 2023-03-29
Results Overview
Number of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
193 participants
Primary outcome timeframe
90 days
Results posted on
2023-03-29
Participant Flow
Excluded (n=84) Hemodynamic instability (n=36) Chest tube placed at outside facility (n=12) Multiple chest tube placement (n=10) Declined to participate (n=1) Not meet inclusion criteria (n=6) Other reasons (n=19)
Participant milestones
| Measure |
28 French Chest Tube for Hemothorax
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
|
Overall Study
COMPLETED
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
28 French Chest Tube for Hemothorax
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
28 French Chest Tube for Hemothorax
n=55 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=54 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.9 years
n=55 Participants
|
46.5 years
n=54 Participants
|
49 years
n=109 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=55 Participants
|
15 Participants
n=54 Participants
|
32 Participants
n=109 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=55 Participants
|
39 Participants
n=54 Participants
|
77 Participants
n=109 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Injury Severity Score - score that ranges from 3 (least) to 75 (most) injured
|
17 units on a scale
n=55 Participants
|
18 units on a scale
n=54 Participants
|
17 units on a scale
n=109 Participants
|
PRIMARY outcome
Timeframe: 90 daysNumber of Participants with Retained hemothorax requiring an additional intervention, either video-assisted thoracoscopic surgery (VATS) or additional thoracostomy tube placement.
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Number of Participants With Retained Hemothorax Following Initial Chest Tube Placement Requiring Intervention
|
51 Number of Participants
|
48 Number of Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of days with chest tube placement
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Duration of Chest Tube Placement.
|
3.9 days
Interval 2.6 to 5.3
|
3.9 days
Interval 2.8 to 5.8
|
SECONDARY outcome
Timeframe: 90 daysNumber of weeks spent in hospital
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Number of Participants Stratified by Length of Hospitalization Stay
1 Week
|
20 Number of Participants
|
15 Number of Participants
|
|
Number of Participants Stratified by Length of Hospitalization Stay
2 Weeks
|
19 Number of Participants
|
15 Number of Participants
|
|
Number of Participants Stratified by Length of Hospitalization Stay
3 Weeks
|
7 Number of Participants
|
6 Number of Participants
|
|
Number of Participants Stratified by Length of Hospitalization Stay
> or = 4 Weeks
|
5 Number of Participants
|
12 Number of Participants
|
SECONDARY outcome
Timeframe: 90 daysAssessed with 0-10 numeric pain rating scale - the higher the number, the more severe the pain
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Change in Subjective Pain Scores From Baseline at 90 Days
|
0 units on a scale
Interval -1.0 to 2.0
|
0 units on a scale
Interval -2.0 to 2.0
|
SECONDARY outcome
Timeframe: 90 daysdetermined by vital signs: temperature, heart rate, blood pressure, oxygen saturation (Systolic Blood Pressure \<90mm Hg)
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Hemodynamic Stability Post-insertion
|
2 Number of Participants
|
1 Number of Participants
|
SECONDARY outcome
Timeframe: 5 MinutesMilliliters of chest tube drainage at 5 minutes
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Initial Drainage From Chest Tube at 5 Minutes
|
150 mL
Interval 60.0 to 500.0
|
100 mL
Interval 3.5 to 350.0
|
SECONDARY outcome
Timeframe: 90 daysNumber of Tube specific complications: Air leak, tube malposition, \& tube migration
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Tube Specific Complications: Air Leak, Tube Malposition, & Tube Migration
|
7 Ocurrences
|
5 Ocurrences
|
SECONDARY outcome
Timeframe: 90 daysNumber of days until radiographic resolution of pneumothorax/hemothorax/hemopneumothorax
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Time to Radiographic Resolution of Pneumothorax/Hemothorax/Hemopneumothorax
|
0.5 days
Interval 0.1 to 2.7
|
1 days
Interval 0.1 to 2.7
|
SECONDARY outcome
Timeframe: 90 daysNumber of Participants with Recurrent pneumothorax/hemothorax/hemopneumothorax after tube removal
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Recurrent Pneumothorax/Hemothorax/Hemopneumothorax After Tube Removal
|
5 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of Participants readmitted for chest tube related complications
Outcome measures
| Measure |
28 French Chest Tube for Hemothorax
n=51 Participants
28 French straight chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
14 French Chest Tube for Hemothorax
n=48 Participants
14 French thal chest tube placed for non-emergent drainage of hemothorax or hemopneumothorax
Chest tube placement: Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
|
|---|---|---|
|
Readmission for Chest Tube Related Complications
|
9 participants
|
4 participants
|
Adverse Events
28 French Chest Tube for Hemothorax
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
14 French Chest Tube for Hemothorax
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place