Xenon Against Postoperative Oxygen Impairment

Capital Medical University

Status: Unknown

Conditions: Acute Lung Injury

Treatments: Other: oxygen; Drug: Xenon

Study type: Interventional

Funder types: Other

Identifiers

NCT02468531

2014.7-2017.7

Details and patient eligibility

About

Acute lung injury (ALI) is the vital complication of Stanford type A aortic dissection. It is confirmed that Xenon has the significant protective effect on important organs and has no suppression on the cardiovascular system. Furthermore, our earlier trial has already clarified that static inflation with 50% Xenon during cardiopulmonary bypass could attenuate ALI for Standford A acute aortic dissection. However the protection effect was restricted for the limited time. Aimed to enhance the protection effect of Xenon, we designed this randomized trial that anesthesia with 50% xenon one hour before and after CPB and pulmonary static Inflation with 50%,75% and 100% Xenon during CPB respectively.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Consultant's clinical diagnosis of Stanford type A AAD using local pathways of diagnosis, which may include clinical history, chest radiography (X-rays), transthoracic ultrasound, and contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI)

Patients aged 18 to 65 years

Eligible for AAD surgery

Exclusion Criteria

Have coronary heart disease, heart failure, severe cardiac tamponade, unstable hemodynamics, severe nervous system abnormalities, clinically apparent malperfusion[9] including lower limb, cerebral, coronary and renal malperfusion, and visceral ischemia, sever hepatic and renal abnormalities

Have undergone any of the cardiac and thoracic surgeries

Are unlikely to be able to perform the required clinical assessment tasks

Have significant cognitive impairment or language issues

Are unable to provide consent with regard to their participation in the study

Prescribed with non-steroidal anti-inflammatory drugs or corticosteroids before or after admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

Oxygen group

Other group

Description:

50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50% oxygen during CPB.

Treatment:

Other: oxygen

Xenon group

Experimental group

Description:

50% oxygen inhalation one hour before and after CPB,and Pulmonary Static Inflation with 50%,75% and 100% Xenon during CPB respectively.

Treatment:

Drug: Xenon