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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04776408
• Other study ID #: 109200-F
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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)

Exclusion Criteria:

• Hemodynamic instability or severe COPD, pulmonary embolism

• Acute brain injury, seizure attack, AMI, AIDS, severe arrhythmia

• On pacemaker

• Pregnant

• Thoracic trauma or burn injury

• Pneumothorax

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Nitric Oxide
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• Lung recruitment combined inhaled Nitric oxide
Ventilator combined inhaled Nitric oxide and Electrical Impedance Tomography monitor the V/Q mismatch
• Lung recruitment
Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei county	Banqiao Dist

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Bluth T, Kiss T, Kircher M, Braune A, Bozsak C, Huhle R, Scharffenberg M, Herzog M, Roegner J, Herzog P, Vivona L, Millone M, Dossel O, Andreeff M, Koch T, Kotzerke J, Stender B, Gama de Abreu M. Measurement of relative lung perfusion with electrical impedance and positron emission tomography: an experimental comparative study in pigs. Br J Anaesth. 2019 Aug;123(2):246-254. doi: 10.1016/j.bja.2019.04.056. Epub 2019 May 31. — View Citation

Mauri T, Spinelli E, Scotti E, Colussi G, Basile MC, Crotti S, Tubiolo D, Tagliabue P, Zanella A, Grasselli G, Pesenti A. Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019. Crit Care Med. 2020 Aug;48(8):1129-1134. doi: 10.1097/CCM.0000000000004386. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	V/Q mismatch	Compare the V/Q mismatch between two groups	15 minutes
Secondary	PaO2/FiO2 ratio improvement rate	Oxygention improve rate	15 minutes

External Links

•   Measurement of relative lung perfusion with electrical impedance and positron emission tomography: an experimental comparative study in pigs
•   Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019