iNO as Salvage Treatment of Hypoxemia After TAAD Surgery

February 1, 2020 updated by: Shanghai Zhongshan Hospital

Inhaled Nitric Oxide as Salvage Treatment of Hypoxemia After Type A Acute Aortic Dissection Surgery (INSTEAD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Zhongshan Hospital Fudan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

post-surgical type A aortic dissection patients with hypoxemia

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 oxide
using of inhaled nitric oxide
Other Names:
  • iNO
Device: PEEP
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
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 oxide
using of inhaled nitric oxide
Other Names:
  • iNO
Device: PEEP
increasing PEEP or decreasing PEEP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intrapulmonary shunt with a PEEP of 5 cm H2O
Time Frame: 6 to 24 hours after surgery
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
Time Frame: 30 minutes after increasing PEEP to 10cm 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
Time Frame: 30 minutes after inhaling 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
Time Frame: 30 minutes after decreasing PEEP to 5cm 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
cardiac output collected from PAC with a PEEP of 5 cm H2O
Time Frame: 6 to 24 hours after surgery
cardiac output in L/min
6 to 24 hours after surgery
pulmonary artery pressure collected from PAC with a PEEP of 5 cm H2O
Time Frame: 6 to 24 hours after surgery
pulmonary artery pressure in mmHg
6 to 24 hours after surgery
pulmonary artery wedge pressure collected from PAC with a PEEP of 5 cm H2O
Time Frame: 6 to 24 hours after surgery
pulmonary artery wedge pressure in mmHg
6 to 24 hours after surgery
cardiac output collected from PAC with a PEEP of 10cm H2O
Time Frame: 30 minutes after increasing PEEP to 10cm H2O
cardiac output in L/min
30 minutes after increasing PEEP to 10cm H2O
pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O
Time Frame: 30 minutes after increasing PEEP to 10cm H2O
pulmonary artery pressure in mmHg
30 minutes after increasing PEEP to 10cm H2O
pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O
Time Frame: 30 minutes after increasing PEEP to 10cm H2O
pulmonary artery wedge pressure in mmHg
30 minutes after increasing PEEP to 10cm H2O
cardiac output collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide
Time Frame: 30 minutes after inhaling nitric oxide
cardiac output in L/min
30 minutes after inhaling nitric oxide
pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide
Time Frame: 30 minutes after inhaling nitric oxide
pulmonary artery pressure in mmHg
30 minutes after inhaling nitric oxide
pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide
Time Frame: 30 minutes after inhaling nitric oxide
pulmonary artery wedge pressure in mmHg
30 minutes after inhaling nitric oxide
cardiac output collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O
Time Frame: 30 minutes after decreasing PEEP to 5 cm H2O
cardiac output in L/min
30 minutes after decreasing PEEP to 5 cm H2O
pulmonary artery pressure collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O
Time Frame: 30 minutes after decreasing PEEP to 5 cm H2O
pulmonary artery pressure in mmHg
30 minutes after decreasing PEEP to 5 cm H2O
pulmonary artery wedge pressure collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O
Time Frame: 30 minutes after decreasing PEEP to 5 cm H2O
pulmonary artery wedge pressure in mmHg, etc
30 minutes after decreasing PEEP to 5 cm H2O

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INSTEAD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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