Breath Analysis Technique to Diagnose Pulmonary Embolism

NCT00368836 | Completed Phase 2 Results DMC

• 2 other identifiers: 433R42HL086316-01
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs, but it is not always accurate for individuals who have recently undergone surgery or who have inflammatory-provoking diseases. The purpose of this study is to evaluate the effectiveness of the Carboximeter, a new PE diagnostic device that measures carbon dioxide (CO2) and oxygen (O2) output, in individuals at risk for developing PEs.

Conditions

Pulmonary Embolism

Keywords

Capnography; Thromboembolism; Arthroplasty; D-dimer

Outcome Measures

Primary Outcomes (2)

• Phase I: Percentage Change in the Postoperative End Tidal CO2/O2 Ratio and D-dimer Concentration Relative to the Preoperative Measurement

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

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

• Phase II: Probability of Pulmonary Embolism Diagnosis by D-dimer Alone vs. D-Dimer Plus CO2/O2 for Pulmonary Embolism Diagnosed by CT Scan.

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

  Measured at 45 days

Study Arms (1)

BreathScreen PE + D-dimer

EXPERIMENTAL

CO2/O2 ratio will be measured using the Breath Screen PE device. D-dimer levels will also be collected.

Device: BreathScreen PE

Interventions

BreathScreen PE DEVICE

One minute of breath collection by tidal breathing into the BreathScreen PE and blood draw for D-dimer level

BreathScreen PE + D-dimer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experienced or is scheduled for at least one of the following:
• Hip or knee replacement surgery
• Hip or acetabular fracture surgery
• Pelvic fracture
• Decompression for spinal stenosis surgery
• Scoliosis corrective surgery
• Craniotomy surgery for brain tumor
• Surgery for any of the following cancers: bladder, colon (including caecum and rectum), kidney, ovary, pancreas, or uterus

You may not qualify if:

• Currently undergoing treatment for PE or has received treatment for PE in the 4 weeks prior to study entry
• Hospitalized for fewer than 2 days
• Anatomic abnormality that would prevent use of a mouthpiece
• Living situation that makes follow-up difficult (e.g., homeless, incarcerated)
• Clinical suspicion of PE with signs or symptom suggestive of PE within 24 hours of presentation and at least one risk factor for PE, as defined under the criteria as outlined in this protocol
• CTA of pulmonary arteries ordered by clinical care providers
• years or older or an emancipated 17 year old
• Written informed consent
• Hemodynamic instability, including patients with a systolic blood pressure less than 90 mm Hg
• Severe respiratory distress or the inability to breathe room air without the sensation of severe dyspnea
• Pulse oximetry reading that declines more than 10% when exogenous oxygen is discontinued with accompanying worsening or new dyspnea
• Intubated
• Cannot breathe through the mouth owing to anatomic, physical or mental limitation
• No fixed address, no telephone number, are from out of town or have other reason to suspect difficulty with follow-up
• Incarceration

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• WFD Ventures Incorporated: collaborator

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Related Publications (4)

• Kline JA, Hogg M. Measurement of expired carbon dioxide, oxygen and volume in conjunction with pretest probability estimation as a method to diagnose and exclude pulmonary venous thromboembolism. Clin Physiol Funct Imaging. 2006 Jul;26(4):212-9. doi: 10.1111/j.1475-097X.2006.00672.x.

  PMID: 16836693 BACKGROUND

• Kline JA, Watts J, Courtney D, Lee YY, Hwang S. Severe pulmonary embolism decreases plasma L-arginine. Eur Respir J. 2014 Mar;43(3):906-9. doi: 10.1183/09031936.00171913. Epub 2013 Nov 14. No abstract available.

  PMID: 24232703 DERIVED

• Kline JA, Hogg MM, Courtney DM, Miller CD, Jones AE, Smithline HA. D-dimer threshold increase with pretest probability unlikely for pulmonary embolism to decrease unnecessary computerized tomographic pulmonary angiography. J Thromb Haemost. 2012 Apr;10(4):572-81. doi: 10.1111/j.1538-7836.2012.04647.x.

  PMID: 22284935 DERIVED

• Kline JA, Hogg MM, Courtney DM, Miller CD, Jones AE, Smithline HA, Klekowski N, Lanier R. D-dimer and exhaled CO2/O2 to detect segmental pulmonary embolism in moderate-risk patients. Am J Respir Crit Care Med. 2010 Sep 1;182(5):669-75. doi: 10.1164/rccm.201001-0129OC. Epub 2010 May 6.

  PMID: 20448094 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Jeffrey Kline
• Organization: Carolinas Medical Center

jkline@carolinas.org

704-355-3181

Study Officials

• Jefferey A. Kline, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 21, 2022
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Locations

US (1)