Type A Aortic DissectionNCT04032366
iNO as Salvage Treatment of Hypoxemia After TAAD Surgery
An observational study of Type A Aortic Dissection, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type A Aortic Dissection
- What is being tested?
- inhaled nitric oxide and PEEP
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: post-surgical type A aortic dissection patients with hypoxemia
Who may be able to join
- Adult
- Type A aortic dissection;
- After surgery;
- P/F ratio ≤ 200mmHg
Who cannot join
- Intracardiac shunt;
- Contradiction of PAC;
- Chronic pulmonary diseases before surgery;
- ECMO;
- Anticipation of death within 48 hours after operation;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, 200030
Zhe Luo, PhD, 02164041990 ext. 02164041990, ec@zs-hospital.sh.cn
Guowei Tu, PhD, 02164041990 ext. 02164041990, ec@zs-hospital.sh.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Type A Aortic Dissection
- Being tested
- inhaled nitric oxide, PEEP
- Keywords
- Hypoxemia, Type A acute aortic dissection, inhaled nitric oxide
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled nitric oxideDrug
Also called iNO
using of inhaled nitric oxide
PEEPDevice
increasing PEEP or decreasing PEEP
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: inhaled nitric oxide; Device: 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 Receives: Drug: inhaled nitric oxide; Device: PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrapulmonary shunt with a PEEP of 5 cm H2O
intrapulmonary shunt calculated by Fick equation with a PEEP of 5 cm H2O
Measured: 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
Measured: 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
Measured: 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
Measured: 30 minutes after decreasing PEEP to 5cm H2O
Secondary outcomes (12)
cardiac output collected from PAC with a PEEP of 5 cm H2O
cardiac output in L/min
Measured: 6 to 24 hours after surgery
pulmonary artery pressure collected from PAC with a PEEP of 5 cm H2O
pulmonary artery pressure in mmHg
Measured: 6 to 24 hours after surgery
pulmonary artery wedge pressure collected from PAC with a PEEP of 5 cm H2O
pulmonary artery wedge pressure in mmHg
Measured: 6 to 24 hours after surgery
cardiac output collected from PAC with a PEEP of 10cm H2O
cardiac output in L/min
Measured: 30 minutes after increasing PEEP to 10cm H2O
pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O
pulmonary artery pressure in mmHg
Measured: 30 minutes after increasing PEEP to 10cm H2O
pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O
pulmonary artery wedge pressure in mmHg
Measured: 30 minutes after increasing PEEP to 10cm H2O
cardiac output collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide
cardiac output in L/min
Measured: 30 minutes after inhaling nitric oxide
pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide
pulmonary artery pressure in mmHg
Measured: 30 minutes after inhaling nitric oxide
pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide
pulmonary artery wedge pressure in mmHg
Measured: 30 minutes after inhaling nitric oxide
cardiac output collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O
cardiac output in L/min
Measured: 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
pulmonary artery pressure in mmHg
Measured: 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
pulmonary artery wedge pressure in mmHg, etc
Measured: 30 minutes after decreasing PEEP to 5 cm H2O
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guo-wei Tu, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032366
- Sponsor's protocol ID
- INSTEAD
- Status last verified
- Jul 2019
- First submitted
- 16 Jul 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide as Salvage Treatment of Hypoxemia After Type A Acute Aortic Dissection Surgery (INSTEAD)
- ClinicalTrials.gov ID
- NCT04032366
- Acronym / sponsor ID
- INSTEAD
- Conditions
- Type A Aortic Dissection
- Keywords
- Hypoxemia, Type A acute aortic dissection, inhaled nitric oxide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEEP 5 | – | –post-surgical type A acute aortic dissection patients was ventilated with a PEEP of 5cm H2O, without inhaled nitric oxide |
| PEEP 10 | – | Drug: inhaled nitric oxide, Device: PEEPpost-surgical type A acute aortic dissection patients was ventilated with a PEEP of 10cm H2O, without inhaled nitric oxide |
| 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 | – | Drug: inhaled nitric oxide, Device: PEEPpost-surgical type A acute aortic dissection patients was ventilated with a PEEP of 5cm H2O, with inhaled nitric oxide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post-surgical type A aortic dissection patients with hypoxemia
Key inclusion criteria (4 listed)
- Adult
- Type A aortic dissection;
- After surgery;
- P/F ratio ≤ 200mmHg
Key exclusion criteria (5 listed)
- Intracardiac shunt;
- Contradiction of PAC;
- Chronic pulmonary diseases before surgery;
- ECMO;
- Anticipation of death within 48 hours after operation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inhaled nitric oxideAlso: iNOusing of inhaled nitric oxide | Drug | PEEP 10, PEEP 5 +iNO |
| PEEPincreasing PEEP or decreasing PEEP | Device | PEEP 10, PEEP 5 +iNO |
Primary outcome
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
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
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
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
12 secondary outcomes
cardiac output collected from PAC with a PEEP of 5 cm H2O
Time frame: 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 wedge pressure collected from PAC with a PEEP of 5 cm H2O
Time frame: 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
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 wedge pressure collected from PAC with a PEEP of 10 cm H2O
Time frame: 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
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 wedge pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide
Time frame: 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
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 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo-wei Tu, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type A Aortic Dissection, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhe Luo, PhD (02164041990 ext. 02164041990, ec@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrapulmonary shunt with a PEEP of 5 cm H2O (time frame: 6 to 24 hours after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.