Nitric Oxide to Treat Pulmonary Embolism

This is a randomized, double blind study to treat subjects diagnosed with pulmonary embolism
with inhaled nitrix oxide. In this clinical trial investigators will randomized patients to
receive inhaled nitric oxide or sham (nitrogen + oxygen) for 24 hours. Patients must have a
submassive pulmonary embolism (PE) and evidence of right ventricular (RV) heart dysfunction.
Investigators hypothesize that the administration of inhaled NO + oxygen to patients with
severe submassive PE will improve RV function, reduce RV strain and necrosis and improve
dyspnea (difficulty breathing) more than sham oxygen treatment.

Inclusion Criteria:

- Age >/= 18

- Pulmonary imaging-proven PE, as interpreted by local radiologist

- At least one predictor of RV dysfunction:

1. echocardiography with RV dilation or hypokinesis,

2. estimated RVSP >40mm HG,

3. RV>LV on CTPA,

4. elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL),

5. screening bedside cardiac ultrasound with color flow capability that shows RV
dysfunction,

6. RV strain on ECG

- Plan to admit to a bed with telemetry capability

Exclusion Criteria:

- Vasopressor support at time of enrollment

- Pregnancy

- Plan by clinical care team to use lytic or surgical embolectomy

- Plan by clinical team to use platelet inhibiting drugs

- Contraindication to anticoagulation

- Altered mental status such that the patient is unable to provide informed consent

- Inability to use a nasal cannula or face mask

- Comfort care measures instituted

- Supplemental oxygen requirements greater than can be administered via nasal cannula in
order to maintain Sa)2 > 80%

- Pneumothorax with decompression

- Serum MetHb > 10%

- Recent use of drugs known to increase cGMP

- Use of nitroprusside or nitroglycerin within the last 4 hours

- Use of any other nitrates with in the past 24 hours

- Use of a fibrinolytic medicine within the past 14 days