iNO as Salvage Treatment of Hypoxemia After TAAD Surgery

Type A Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04032366
• Other study ID #: INSTEAD
• Status: Recruiting
• Start date: April 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Zhe Luo, PhD
• Phone: 02164041990
• Email: ec[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Hypoxia
• Type A Aortic Dissection

Intervention

Drug:
• inhaled nitric oxide
using of inhaled nitric oxide

Device:
• PEEP
increasing PEEP or decreasing PEEP

Locations

Country	Name	City	State
China	Zhongshan hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	cardiac output collected from PAC with a PEEP of 5 cm H2O	cardiac output in L/min	6 to 24 hours after surgery
Secondary	pulmonary artery pressure collected from PAC with a PEEP of 5 cm H2O	pulmonary artery pressure in mmHg	6 to 24 hours after surgery
Secondary	pulmonary artery wedge pressure collected from PAC with a PEEP of 5 cm H2O	pulmonary artery wedge pressure in mmHg	6 to 24 hours after surgery
Secondary	cardiac output collected from PAC with a PEEP of 10cm H2O	cardiac output in L/min	30 minutes after increasing PEEP to 10cm H2O
Secondary	pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O	pulmonary artery pressure in mmHg	30 minutes after increasing PEEP to 10cm H2O
Secondary	pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O	pulmonary artery wedge pressure in mmHg	30 minutes after increasing PEEP to 10cm H2O
Secondary	cardiac output collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide	cardiac output in L/min	30 minutes after inhaling nitric oxide
Secondary	pulmonary artery pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide	pulmonary artery pressure in mmHg	30 minutes after inhaling nitric oxide
Secondary	pulmonary artery wedge pressure collected from PAC with a PEEP of 10 cm H2O and inhaled nitric oxide	pulmonary artery wedge pressure in mmHg	30 minutes after inhaling nitric oxide
Secondary	cardiac output collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O	cardiac output in L/min	30 minutes after decreasing PEEP to 5 cm H2O
Secondary	pulmonary artery pressure collected from PAC with inhaled nitric oxide and a PEEP of 5 cm H2O	pulmonary artery pressure in mmHg	30 minutes after decreasing PEEP to 5 cm H2O
Secondary	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	30 minutes after decreasing PEEP to 5 cm H2O