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iNO as Salvage Treatment of Hypoxemia After TAAD Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04032366
Enrollment
20
Registered
2019-07-25
Start date
2019-04-01
Completion date
2021-12-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type A Aortic Dissection

Keywords

Hypoxemia, Type A acute aortic dissection, inhaled nitric oxide

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.

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.

Interventions

DRUGinhaled nitric oxide

using of inhaled nitric oxide

DEVICEPEEP

increasing PEEP or decreasing PEEP

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Intrapulmonary shunt with a PEEP of 5 cm H2O6 to 24 hours after surgeryintrapulmonary shunt calculated by Fick equation with a PEEP of 5 cm H2O
Intrapulmonary shunt with a PEEP of 10 cm H2O30 minutes after increasing PEEP to 10cm H2Ointrapulmonary shunt calculated by Fick equation with a PEEP of 10 cm H2O
Intrapulmonary shunt with a PEEP of 10 cm H2O and inhaled nitric oxide30 minutes after inhaling nitric oxideintrapulmonary 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 H2O30 minutes after decreasing PEEP to 5cm H2Ointrapulmonary shunt calculated by Fick equation with inhaled nitric oxide and a PEEP of 5 cm H2O

Secondary

MeasureTime frameDescription
pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O30 minutes after increasing PEEP to 10cm H2Opulmonary artery pressure in mmHg
pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O30 minutes after increasing PEEP to 10cm H2Opulmonary artery wedge pressure in mmHg
cardiac output collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide30 minutes after inhaling nitric oxidecardiac output in L/min
pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide30 minutes after inhaling nitric oxidepulmonary artery pressure in mmHg
cardiac output collected from PAC with a PEEP of 5 cm H2O6 to 24 hours after surgerycardiac output in L/min
cardiac output collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O30 minutes after decreasing PEEP to 5 cm H2Ocardiac output in L/min
pulmonary artery pressure collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O30 minutes after decreasing PEEP to 5 cm H2Opulmonary artery pressure in mmHg
pulmonary artery wedge pressure collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O30 minutes after decreasing PEEP to 5 cm H2Opulmonary artery wedge pressure in mmHg, etc
pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide30 minutes after inhaling nitric oxidepulmonary artery wedge pressure in mmHg
pulmonary artery pressure collected from PAC with a PEEP of 5 cm H2O6 to 24 hours after surgerypulmonary artery pressure in mmHg
pulmonary artery wedge pressure collected from PAC with a PEEP of 5 cm H2O6 to 24 hours after surgerypulmonary artery wedge pressure in mmHg
cardiac output collected from PAC with a PEEP of 10cm H2O30 minutes after increasing PEEP to 10cm H2Ocardiac output in L/min

Countries

China

Contacts

Primary ContactZhe Luo, PhD
ec@zs-hospital.sh.cn02164041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026