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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNO Group | Experimental | Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions |
|
| Control | Other | Patients are treated without iNO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled Nitric Oxide | Drug | Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guo-wei Tu, MD | Contact | +8613501996995 | tu.guowei@zs-hospital.sh.cn | |
| Guo-guang Ma, MD | Contact | +8615021519979 | ma.guoguang@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhe Luo, PhD | Department of Critical Care Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24514031 | Background | Garcia-Delgado M, Navarrete-Sanchez 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. | |
| 27168252 | Background | Ball L, Battaglini D, Pelosi P. Postoperative respiratory disorders. Curr Opin Crit Care. 2016 Aug;22(4):379-85. doi: 10.1097/MCC.0000000000000312. |
| Label | URL |
|---|---|
| Springer | View source |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000074743 | Hemodynamic Monitoring |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008991 | Monitoring, Physiologic |
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| lung protective mechanical ventilation | Device | Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg |
|
| Hemodynamic monitoring | Device | Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management. |
|
| 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. |
| 16371634 | Background | Griffiths MJ, Evans TW. Inhaled nitric oxide therapy in adults. N Engl J Med. 2005 Dec 22;353(25):2683-95. doi: 10.1056/NEJMra051884. No abstract available. |
| 16865510 | Result | Nakajima T, Kawazoe K, Izumoto H, Kataoka T, Niinuma H, Shirahashi N. Risk factors for hypoxemia after surgery for acute type A aortic dissection. Surg Today. 2006;36(8):680-5. doi: 10.1007/s00595-006-3226-5. |
| 23631417 | Result | Wang Y, Xue S, Zhu H. Risk factors for postoperative hypoxemia in patients undergoing Stanford A aortic dissection surgery. J Cardiothorac Surg. 2013 Apr 30;8:118. doi: 10.1186/1749-8090-8-118. |
| 3495737 | Result | Palmer RM, Ferrige AG, Moncada S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 1987 Jun 11-17;327(6122):524-6. doi: 10.1038/327524a0. |
| 2040056 | Result | Frostell C, Fratacci MD, Wain JC, Jones R, Zapol WM. Inhaled nitric oxide. A selective pulmonary vasodilator reversing hypoxic pulmonary vasoconstriction. Circulation. 1991 Jun;83(6):2038-47. doi: 10.1161/01.cir.83.6.2038. |
| 8457043 | Result | Frostell CG, Blomqvist H, Hedenstierna G, Lundberg J, Zapol WM. Inhaled nitric oxide selectively reverses human hypoxic pulmonary vasoconstriction without causing systemic vasodilation. Anesthesiology. 1993 Mar;78(3):427-35. doi: 10.1097/00000542-199303000-00005. |
| 26186889 | Result | Benedetto M, Romano R, Baca G, Sarridou D, Fischer A, Simon A, Marczin N. Inhaled nitric oxide in cardiac surgery: Evidence or tradition? Nitric Oxide. 2015 Sep 15;49:67-79. doi: 10.1016/j.niox.2015.06.002. Epub 2015 Jul 14. |
| 10675427 | Result | Clark RH, Kueser TJ, Walker MW, Southgate WM, Huckaby JL, Perez JA, Roy BJ, Keszler M, Kinsella JP. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group. N Engl J Med. 2000 Feb 17;342(7):469-74. doi: 10.1056/NEJM200002173420704. |
| 10545552 | Result | Cornfield DN, Maynard RC, deRegnier RA, Guiang SF 3rd, Barbato JE, Milla CE. Randomized, controlled trial of low-dose inhaled nitric oxide in the treatment of term and near-term infants with respiratory failure and pulmonary hypertension. Pediatrics. 1999 Nov;104(5 Pt 1):1089-94. doi: 10.1542/peds.104.5.1089. |
| biomed central | View source |
| Nature Publishing Group | View source |