Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery
Study Details
Study Description
Brief Summary
Hypoxemia is a common complication after aortic surgery. As this complication has an adverse effect on the postoperative course of the patient, early treatment is important; however, the mechanism of hypoxemia after surgery for acute aortic dissection remains unclear. Recently, the investigators found that inhaled Nitric Oxide can improve the oxygenation in some of these patients. The investigators are trying to evaluate the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Several risk factors for severe hypoxemia after aortic surgery have been reported including advanced age, obesity, smoking history, previous heart surgery,emergency surgery,reduced cardiac function, advanced chronic obstructive pulmonary disease, excessive volume of blood transfusion,and prolonged CPB time. The routine treatment includes lung protective mechanical ventilation, recruitment maneuvers and glucocorticoids.
No previous clinical studies have reported the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: iNO Group Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions |
Drug: Inhaled Nitric Oxide
Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.
Device: lung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
Device: Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
|
| Other: Control Patients are treated without iNO. |
Device: lung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
Device: Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
|
Outcome Measures
Primary Outcome Measures
- Mechanical ventilation time (days) [During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months.]
Secondary Outcome Measures
- ICU mortality [From date of randomization until the date of death or discharge from ICU, up to 6 months.]
- length of hospital stay (days) [From date of randomization until the date of death or discharge from hospital, up to 6 months.]
- length of ICU stay (days) [From date of randomization until the date of death or discharge from ICU, up to 6 months.]
- hospital mortality [From date of randomization until the date of death or discharge from hospital, up to 6 months.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adult patients with refractory hypoxemia after aortic surgery;
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Accepting invasive mechanical ventilation;
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Chest X-ray and lung ultrasound to exclude the respiratory factors (eg. pulmonary edema, obstructive atelectasis, pleural effusion, pneumothorax) and hemodynamic factors (pericardial tamponade, acute pulmonary hypertension, intracardiac shunt);
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The ventilator parameters: PEEP>10cmH2O, VT 6-8ml/kg;
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The PaO2/FiO2 <= 100mmHg.
Exclusion Criteria:
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Age <18 years old;
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Pregnant women;
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Past medical history included COPD or mental illness;
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The serious infection or sepsis patients;
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Patients with pulmonary hypertension and right ventricular dysfunction
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Zhongshan Hospital | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai Zhongshan Hospital
Investigators
- Study Director: Zhe Luo, PhD, Department of Critical Care Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Ball L, Battaglini D, Pelosi P. Postoperative respiratory disorders. Curr Opin Crit Care. 2016 Aug;22(4):379-85. doi: 10.1097/MCC.0000000000000312. Review.
- García-Delgado M, Navarrete-Sánchez I, Colmenero M. Preventing and managing perioperative pulmonary complications following cardiac surgery. Curr Opin Anaesthesiol. 2014 Apr;27(2):146-52. doi: 10.1097/ACO.0000000000000059. Review.
- Griffiths MJ, Evans TW. Inhaled nitric oxide therapy in adults. N Engl J Med. 2005 Dec 22;353(25):2683-95. Review.
- STiNO