iNO as Salvage Treatment of Hypoxemia After TAAD Surgery

NCT ID: NCT04032366

Last Updated: 2020-02-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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The investigators' previous study has stressed that inhaled nitric oxide therapy might play an ameliorative role in patients with refractory hypoxemia after surgical treatment of type A acute aortic dissection. The possible reason might be the decreasing of intrapulmonary shunt because previous studies showed that inhaled nitric oxide could decrease intrapulmonary shunt by selectively dilating the pulmonary vessels in ventilated areas. As a result, the investigators designed this observational study to calculate the intrapulmonary shunt before and after inhaled nitric oxide therapy. Intrapulmonary shunt was calculated from oxygen content (CO2) of different sites ( artery, mixed venous, alveolar capillary) by Fick equation:(CaO2-CcO2)/(CvO2-CcO2). A FiO2 of 1.0 and tidal volume of 6\~8 ml/kg were chosen. Oxygen content was calculated from hemoglobin (Hb), oxygen saturation (SO2) and oxygen partial pressure (PO2) by the following equation: CO2 = 1.34\*Hb\*SO2 + 0,0031\*PO2. PaO2, SaO2, PvO2 and SvO2 were measured from arterial and mixed venous blood samples taken from the radial arterial catheter and from the pulmonary artery catheter. ScO2 was estimated to be 1.0 with a FiO2 of 100%. PcO2 was considered to be the same as PAO2 (partial pressure of oxygen in the alveoli), and was calculated from the alveolar gas equation with PAO2 = \[(atmospheric pressure - 47) \* (FiO2)\] - PaCO2/0.8.Other variables such as hemodynamic variables from pulmonary artery catheter were also collected.

Conditions

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Type A Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PEEP 5

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

No interventions assigned to this group

PEEP 10

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

inhaled nitric oxide

Intervention Type DRUG

using of inhaled nitric oxide

PEEP

Intervention Type DEVICE

increasing PEEP or decreasing PEEP

PEEP 10 +iNO

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

No interventions assigned to this group

PEEP 5 +iNO

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

inhaled nitric oxide

Intervention Type DRUG

using of inhaled nitric oxide

PEEP

Intervention Type DEVICE

increasing PEEP or decreasing PEEP

Interventions

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inhaled nitric oxide

using of inhaled nitric oxide

Intervention Type DRUG

PEEP

increasing PEEP or decreasing PEEP

Intervention Type DEVICE

Other Intervention Names

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iNO

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Intracardiac shunt;
* Contradiction of PAC;
* Chronic pulmonary diseases before surgery;
* ECMO;
* Anticipation of death within 48 hours after operation;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guo-wei Tu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhe Luo, PhD

Role: CONTACT

02164041990 ext. 02164041990

Facility Contacts

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Zhe Luo, PhD

Role: primary

02164041990 ext. 02164041990

Guowei Tu, PhD

Role: backup

02164041990 ext. 02164041990

Other Identifiers

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INSTEAD

Identifier Type: -

Identifier Source: org_study_id

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