Trial Outcomes & Findings for Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax (NCT NCT02619591)

Results Overview

The presence of a pneumothorax at the time of the ultrasound

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

260 participants

Primary outcome timeframe

up to 20 minutes

Results posted on

2016-11-07

Patients with chest trauma presenting to the emergency department who were going to get a CT of the chest were eligible

Exclusions were patients who had recieved a chest tube already, or those with known pneumothoraces.

Participant milestones
Measure	"Device" - Ultrasound Imaging - Single View Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine.	"Device" - Ultrasound Imaging - Multiple Views Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine.
Overall Study STARTED	139	121
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	139	121

Withdrawal data not reported

Comparison Of Chest Ultrasound Techniques To Identify Clinically Significant Pneumothorax

Baseline characteristics by cohort
Measure	Ultrasound Imaging - Single View n=139 Participants Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine.	Ultrasound Imaging - Multiple Views n=121 Participants Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine.	Total n=260 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 13 • n=5 Participants	45 years STANDARD_DEVIATION 12 • n=7 Participants	45 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	35 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	86 Participants n=7 Participants	186 Participants n=5 Participants
Region of Enrollment United States	139 participants n=5 Participants	121 participants n=7 Participants	260 participants n=5 Participants
Blunt Trauma Blunt Truama	133 participants n=5 Participants	115 participants n=7 Participants	248 participants n=5 Participants
Blunt Trauma Penetrating Trauma	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

Timeframe: up to 20 minutes

The presence of a pneumothorax at the time of the ultrasound

Outcome measures
Measure	"Device" - Ultrasound Imaging - Single View n=139 Participants Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine.	"Device" - Ultrasound Imaging - Multiple Views n=121 Participants Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine.
Pneumothorax (Positive or Negative)	17 participants	21 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

UMASS Memorial Department of Emergency Medicine

Phone: 508-421-1400