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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Acute Respiratory Distress Syndrome; Nitric Oxide
• Intervention / Treatment: Device: Lung recruitment; Device: Lung recruitment combined inhaled Nitric oxide

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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Banqiao Dist
    • Taipei county, Banqiao Dist, Taiwan, 22060
      • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
V/Q mismatch	Compare the V/Q mismatch between two groups	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 ratio improvement rate	Oxygention improve rate	15 minutes

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Study Director: Hou T Chang, doctor, Far Eastern Memorial Hospital; Study Director: Ping H Wang, Bachelor, Far Eastern Memorial Hospital; Study Director: Mei Y Chang, Master, Far Eastern Memorial Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress Syndrome; Electrical Impedance Tomography; Inhaled Nitric Oxide; Ventilation-Perfusion mismatch; Lung recruitment
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: 109200-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Still in the research phase.May be consider later

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No