NCT04032366

Brief Summary

The purpose of this study was to clarify the possible mechanism of hypoxemia after surgical treatment of type A acute aortic dissection and the possible mechanism of the treatment role of inhaled nitric oxide in refractory hypoxemia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 5, 2020

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

July 16, 2019

Last Update Submit

February 1, 2020

Conditions

Type A Aortic Dissection

Keywords

HypoxemiaType A acute aortic dissectioninhaled nitric oxide

Outcome Measures

Primary Outcomes (4)

  • Intrapulmonary shunt with a PEEP of 5 cm H2O

    intrapulmonary shunt calculated by Fick equation with a PEEP of 5 cm H2O

    6 to 24 hours after surgery

  • Intrapulmonary shunt with a PEEP of 10 cm H2O

    intrapulmonary shunt calculated by Fick equation with a PEEP of 10 cm H2O

    30 minutes after increasing PEEP to 10cm H2O

  • Intrapulmonary shunt with a PEEP of 10 cm H2O and inhaled nitric oxide

    intrapulmonary shunt calculated by Fick equation with a PEEP of 10 cm H2O and inhaled nitric oxide

    30 minutes after inhaling nitric oxide

  • Intrapulmonary shunt with inhaled nitric oxide and a PEEP of 5 cm H2O

    intrapulmonary shunt calculated by Fick equation with inhaled nitric oxide and a PEEP of 5 cm H2O

    30 minutes after decreasing PEEP to 5cm H2O

Secondary Outcomes (12)

  • cardiac output collected from PAC with a PEEP of 5 cm H2O

    6 to 24 hours after surgery

  • pulmonary artery pressure collected from PAC with a PEEP of 5 cm H2O

    6 to 24 hours after surgery

  • pulmonary artery wedge pressure collected from PAC with a PEEP of 5 cm H2O

    6 to 24 hours after surgery

  • cardiac output collected from PAC with a PEEP of 10cm H2O

    30 minutes after increasing PEEP to 10cm H2O

  • pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O

    30 minutes after increasing PEEP to 10cm H2O

  • +7 more secondary outcomes

Study Arms (4)

PEEP 5

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 5cm H2O, without inhaled nitric oxide

PEEP 10

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 10cm H2O, without inhaled nitric oxide

Drug: inhaled nitric oxideDevice: PEEP

PEEP 10 +iNO

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 10cm H2O, with inhaled nitric oxide

PEEP 5 +iNO

post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 5cm H2O, with inhaled nitric oxide

Drug: inhaled nitric oxideDevice: PEEP

Interventions

inhaled nitric oxideDRUG

using of inhaled nitric oxide

Also known as: iNO
PEEP 10PEEP 5 +iNO
PEEPDEVICE

increasing PEEP or decreasing PEEP

PEEP 10PEEP 5 +iNO

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

post-surgical type A aortic dissection patients with hypoxemia

You may qualify if:

  • Adult
  • Type A aortic dissection;
  • After surgery;
  • P/F ratio ≤ 200mmHg

You may not qualify if:

  • Intracardiac shunt;
  • Contradiction of PAC;
  • Chronic pulmonary diseases before surgery;
  • ECMO;
  • Anticipation of death within 48 hours after operation;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood and serum

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guo-wei Tu, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Luo, PhD

CONTACT

02164041990ec@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2019

First Posted

July 25, 2019

Study Start

April 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 5, 2020

Record last verified: 2019-07

Locations

CN(1)