Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery
NCT ID: NCT03009643
Last Updated: 2018-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-10-31
2019-12-31
Brief Summary
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Detailed Description
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No previous clinical studies have reported the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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iNO Group
Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
Inhaled Nitric Oxide
Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.
lung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
Control
Patients are treated without iNO.
lung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
Interventions
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Inhaled Nitric Oxide
Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.
lung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
Eligibility Criteria
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Inclusion Criteria
2. Accepting invasive mechanical ventilation;
3. 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);
4. The ventilator parameters: PEEP\>10cmH2O, VT 6-8ml/kg;
5. The PaO2/FiO2 \<= 100mmHg.
Exclusion Criteria
2. Pregnant women;
3. Past medical history included COPD or mental illness;
4. The serious infection or sepsis patients;
5. Patients with pulmonary hypertension and right ventricular dysfunction
18 Years
ALL
No
Sponsors
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Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Guowei Tu
Attending doctor, Department of cardiac surgery intensive care unit, Principal Investigator
Principal Investigators
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Zhe Luo, PhD
Role: STUDY_DIRECTOR
Department of Critical Care Medicine
Locations
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Shanghai Zhongshan Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Ball L, Battaglini D, Pelosi P. Postoperative respiratory disorders. Curr Opin Crit Care. 2016 Aug;22(4):379-85. doi: 10.1097/MCC.0000000000000312.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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biomed central
Nature Publishing Group
Other Identifiers
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STiNO
Identifier Type: -
Identifier Source: org_study_id
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