Trial Outcomes & Findings for Breath Analysis Technique to Diagnose Pulmonary Embolism (NCT NCT00368836)

Results Overview

Median postoperative change in end tidal CO2/O2 ratio calculated as 100% \* \[(postoperative-preoperative)/(preoperative)\]

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

475 participants

Primary outcome timeframe

Pre-op measurement: the morning of surgery. Post-op measurement: the latter of postoperative day 3 or hospital discharge

Results posted on

2022-04-21

Participant Flow

Phase I - subjects scheduled for elective surgery enrolled from January 2006-May 2006. Phase II - Hospitalized as well as Emergency Department patients were enrolled from February, 2007 to April, 2008

Participant milestones

Participant milestones
Measure	BreathScreen PE BreathScreen PE and D-Dimer collected on subjects scheduled for elective surgery
Phase II STARTED	350
Phase II COMPLETED	329
Phase II NOT COMPLETED	21
Phase I Pre-op/Post-op STARTED	125
Phase I Pre-op/Post-op COMPLETED	104
Phase I Pre-op/Post-op NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	BreathScreen PE BreathScreen PE and D-Dimer collected on subjects scheduled for elective surgery
Phase II Screen Failure	1
Phase II Withdrawal by Subject	1
Phase II unable to collect blood and/or breath	17
Phase II Protocol Violation	2

Baseline Characteristics

Breath Analysis Technique to Diagnose Pulmonary Embolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase II n=350 Participants Symptomatic population undergoing testing for pulmonary embolism. Blood samples were used to obtain D-dimer levels and breath samples were used to generate the BreathScreen PE CO2/O2 ratio.	Phase I n=125 Participants Pre-op/Post op subjects undergoing surgery. Blood and breath samples were collected before and after surgery. Blood samples were used to obtain D-dimer levels and breath samples were used to generate the BreathScreen PE CO2/O2 ratio.	Total n=475 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 15.9 • n=5 Participants	62 years STANDARD_DEVIATION 12 • n=7 Participants	56.3 years STANDARD_DEVIATION 15.3 • n=5 Participants
Sex: Female, Male Female	212 Participants n=5 Participants	67 Participants n=7 Participants	279 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	58 Participants n=7 Participants	196 Participants n=5 Participants
Region of Enrollment United States	350 participants n=5 Participants	125 participants n=7 Participants	475 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-op measurement: the morning of surgery. Post-op measurement: the latter of postoperative day 3 or hospital discharge

Median postoperative change in end tidal CO2/O2 ratio calculated as 100% \* \[(postoperative-preoperative)/(preoperative)\]

Outcome measures

Outcome measures
Measure	BreathScreen PE n=104 Participants BreathScreen PE and D-Dimer collected on subjects scheduled for elective surgery	D-dimer Probability of pulmonary embolism diagnosis by D-dimer alone as compared to D-dimer plus CO2/O2 measured with the BreathScren PE. D-dimer \> 499 ng/ml, etCO2/O2 \< 0.28, Pulmonary Embolism diagnosed by CT scan
Phase I: Percentage Change in the Postoperative End Tidal CO2/O2 Ratio and D-dimer Concentration Relative to the Preoperative Measurement end tidal CO2/O2 ratio	0 percent change Interval -13.0 to 16.0	—
Phase I: Percentage Change in the Postoperative End Tidal CO2/O2 Ratio and D-dimer Concentration Relative to the Preoperative Measurement D-dimer concentration	136 percent change Interval 40.0 to 313.0	—

PRIMARY outcome

Timeframe: Measured at 45 days

Population: Completed patients minus unrecoverable data (4) and indeterminate CT scan (2).

D-dimer \> 499 ng/ml, etCO2/O2 \< 0.28, Pulmonary Embolism diagnosed by CT scan

Outcome measures

Outcome measures
Measure	BreathScreen PE n=323 Participants BreathScreen PE and D-Dimer collected on subjects scheduled for elective surgery	D-dimer n=323 Participants Probability of pulmonary embolism diagnosis by D-dimer alone as compared to D-dimer plus CO2/O2 measured with the BreathScren PE. D-dimer \> 499 ng/ml, etCO2/O2 \< 0.28, Pulmonary Embolism diagnosed by CT scan
Phase II: Probability of Pulmonary Embolism Diagnosis by D-dimer Alone vs. D-Dimer Plus CO2/O2 for Pulmonary Embolism Diagnosed by CT Scan.	0.32 probability of PE diagnosis	0.17 probability of PE diagnosis

Adverse Events

Phase II

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Kline

Carolinas Medical Center

Phone: 704-355-3181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place