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

NCT04776408 | Unknown

• 1 other identifier: 109200-F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nitric Oxide; Acute Respiratory Distress Syndrome

Keywords

Electrical Impedance Tomography; Acute Respiratory Distress Syndrome; Inhaled Nitric Oxide; Ventilation-Perfusion mismatch; Lung recruitment

Outcome Measures

Primary Outcomes (1)

• V/Q mismatch

  Compare the V/Q mismatch between two groups

  15 minutes

Secondary Outcomes (1)

• PaO2/FiO2 ratio improvement rate

  15 minutes

Study Arms (2)

Control group_Use Lung recruitment

ACTIVE COMPARATOR

Use the Lung recruitment,

Device: Lung recruitment

Study group_Use Lung recruitment combined inhaled Nitric oxide

EXPERIMENTAL

Use the Lung recruitment combined inhaled Nitric oxide,

Device: Lung recruitment combined inhaled Nitric oxide

Interventions

Lung recruitment combined inhaled Nitric oxide DEVICE

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

Study group_Use Lung recruitment combined inhaled Nitric oxide

Lung recruitment DEVICE

Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch

Control group_Use Lung recruitment

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Taipei County, Banqiao Dist, 22060, Taiwan

Location

Related 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.

  PMID: 31160064 BACKGROUND

• 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.

  PMID: 32697482 BACKGROUND

Related 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

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During this period, all patients were total sedation using continuous infusion, to prevent any spontaneous breathing .All patients were ventilated using a ventilator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Moderate to severe ARDS patient on mechanical ventilation in Far Eastern Memorial Hospital MICU

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 1, 2021
• Study Start: April 29, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2023

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)