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

NCT ID: NCT04776408

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-29

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nitric Oxide Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Moderate to severe ARDS patient on mechanical ventilation in Far Eastern Memorial Hospital MICU
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Control group_Use Lung recruitment

Use the Lung recruitment,

Group Type ACTIVE_COMPARATOR

Lung recruitment

Intervention Type DEVICE

Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch

Study group_Use Lung recruitment combined inhaled Nitric oxide

Use the Lung recruitment combined inhaled Nitric oxide,

Group Type EXPERIMENTAL

Lung recruitment combined inhaled Nitric oxide

Intervention Type DEVICE

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

Interventions

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Lung recruitment combined inhaled Nitric oxide

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

Intervention Type DEVICE

Lung recruitment

Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hou T Chang, Doctor

Role: STUDY_DIRECTOR

Far Eastern Memorial Hospital

Ping H Wang, Bachelor

Role: STUDY_DIRECTOR

Far Eastern Memorial Hospital

Mei Y Chang, Master

Role: STUDY_DIRECTOR

Far Eastern Memorial Hospital

Locations

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Far Eastern Memorial Hospital

Taipei County, Banqiao Dist, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 31160064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32697482 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/31160064/

Measurement of relative lung perfusion with electrical impedance and positron emission tomography: an experimental comparative study in pigs

https://pubmed.ncbi.nlm.nih.gov/32697482/

Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019

Other Identifiers

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109200-F

Identifier Type: -

Identifier Source: org_study_id

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