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Xenon Against Postoperative Oxygen Impairment

Primary Purpose

Acute Lung Injury

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

oxygen

Xenon

About this trial

This is an interventional treatment trial for Acute Lung Injury focused on measuring Xenon, Standford A acute aortic dissection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Oxygen group

Xenon group

Arm Description

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

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

Outcomes

Primary Outcome Measures

oxygenation index

Secondary Outcome Measures

alterations in cytokine and ROS in the perioperative period

extubation time

complications of vital organs

Full Information

NCT ID

NCT02468531

First Posted

April 20, 2015

Last Updated

November 8, 2016

Sponsor

Beijing Anzhen Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02468531

Brief Title

Xenon Against Postoperative Oxygen Impairment

Official Title

Protection of Xenon Against Postoperative Oxygen Impairment in Adults Undergoing Stanford Type-A Acute Aortic Dissection Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Anzhen Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lung Injury

Keywords

Xenon, Standford A acute aortic dissection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oxygen group

Arm Type

Other

Arm Description

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

Arm Title

Xenon group

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

oxygen

Intervention Description

50% oxygen inhalation

Intervention Type

Drug

Intervention Name(s)

Xenon

Intervention Description

50% Xenon inhalation

Primary Outcome Measure Information:

Title

oxygenation index

Time Frame

perioperative period

Secondary Outcome Measure Information:

Title

alterations in cytokine and ROS in the perioperative period

Time Frame

perioperative period

Title

extubation time

Time Frame

perioperative period

Title

complications of vital organs

Time Frame

perioperative period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weiping Weiping, master

Phone

(86)010-6445-6329

ch_eng9735@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weiping Weiping

Organizational Affiliation

Beijing Anzhen Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Anzhen Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weiping Cheng

12. IPD Sharing Statement

Plan to Share IPD

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