Potential for Inhaled Nitric Oxide and Ventilation-Perfusion Mismatch by Electrical Impedance Tomography in the ARDS Patients With Lung Recruitment

Sponsor

Far Eastern Memorial Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04776408

Collaborator

(none)

100

Enrollment

Location

Arms

8.1

Anticipated Duration (Months)

12.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the recent years, the treatment of Acute Respiratory Distress Syndrome has been proved that lung recruitment re-opens the non-ventilated alveolar to improve ventilation, and inhaled Nitric Oxide dilates non-perfused pulmonary vascular to improve perfusion. Both of these could improve ventilation-perfusion mismatch to enhance oxygenation. However, Ventilation-Perfusion mismatch is devided into ventilated nonperfused lung units(dead space) or perfused nonventilated units(shunt). No published study has evaluated the availability of lung recruitment combined with inhaled Nitric oxide in patients with ARDS.

The aims of our study are to measure dead space or shunt fraction before and after inhaled Nitric Oxide in moderate to severe Acute Respiratory Distress Syndrome patients indicated Nitric oxide in FEMH MICU on 2021/01-2022/12, injected a bolus of 10mL of 3% NaCl solution via the central venous catheter with two-step recruitment maneuver by Electrical Impedance Tomography, which monitors ventilation-perfusion mismatch to evaluate whether the patient has potential to improve V/Q mismatch by Nitric oxide.

Condition or Disease	Intervention/Treatment	Phase
Nitric Oxide Acute Respiratory Distress Syndrome	Device: Lung recruitment combined inhaled Nitric oxide Device: Lung recruitment	N/A

Detailed Description

Normally, pulmonary arteries in areas of alveolar hypoxia will constrict as a physiologic response to preserve ventilation/perfusion (V¬/Q¬) matching. However, in ARDS, this normal vasoconstrictive response is impaired. Because the body is unable to shunt blood away from the diseased alveoli, these nonaerated alveoli receive excessive blood flow, which contributes to severe V¬/Q¬ mismatching and an intrapulmonary right-to-left shunting of blood flow, which causes hypoxemia.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Moderate to severe ARDS patient on mechanical ventilation in Far Eastern Memorial Hospital MICUModerate to severe ARDS patient on mechanical ventilation in Far Eastern Memorial Hospital MICU

Masking:

Single (Participant)

Masking Description:

During this period, all patients were total sedation using continuous infusion, to prevent any spontaneous breathing .All patients were ventilated using a ventilator

Primary Purpose:

Treatment

Official Title:

Potential for Inhaled Nitric Oxide and Ventilation-Perfusion Mismatch by Electrical Impedance Tomography in the Acute Respiratory Distress Syndrome Patients With Lung Recruitment

Actual Study Start Date :

Apr 29, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group_Use Lung recruitment Use the Lung recruitment,	Device: Lung recruitment Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch
Experimental: Study group_Use Lung recruitment combined inhaled Nitric oxide Use the Lung recruitment combined inhaled Nitric oxide,	Device: Lung recruitment combined inhaled Nitric oxide Ventilator combined inhaled Nitric oxide and Electrical Impedance Tomography monitor the V/Q mismatch

Arm

Intervention/Treatment

Active Comparator: Control group_Use Lung recruitment

Use the Lung recruitment,

Device: Lung recruitment

Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch

Experimental: Study group_Use Lung recruitment combined inhaled Nitric oxide

Use the Lung recruitment combined inhaled Nitric oxide,

Device: Lung recruitment combined inhaled Nitric oxide

Ventilator combined inhaled Nitric oxide and Electrical Impedance Tomography monitor the V/Q mismatch

Outcome Measures

Primary Outcome Measures

V/Q mismatch [15 minutes]
Compare the V/Q mismatch between two groups

Secondary Outcome Measures

PaO2/FiO2 ratio improvement rate [15 minutes]
Oxygention improve rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Moderate to severe ARDS patient on mechanical ventilation in MICU. (P/F≦ 200 with PEEP ≥ 5cmH20) (PEEP greater than or equal to 5 cm H2O and Berlin criteria for ARDS)