Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery

Not Applicable

• Conditions: Nitric Oxide; Hypoxemia; Aortic Surgery
• Interventions: Drug: Inhaled Nitric Oxide; Device: lung protective mechanical ventilation; Device: Hemodynamic monitoring

• Registration Number: NCT03009643
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adult patients with refractory hypoxemia after aortic surgery;
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

1. Age <18 years old;
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iNO Group	lung protective mechanical ventilation	Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
iNO Group	Hemodynamic monitoring	Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
Control	lung protective mechanical ventilation	Patients are treated without iNO.
iNO Group	Inhaled Nitric Oxide	Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
Control	Hemodynamic monitoring	Patients are treated without iNO.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China