Potential for Inhaled Nitric Oxide and Ventilation-Perfusion Mismatch by Electrical Impedance Tomography in the ARDS Patients With Lung Recruitment
Primary Purpose
Nitric Oxide, Acute Respiratory Distress Syndrome
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lung recruitment combined inhaled Nitric oxide
Lung recruitment
Sponsored by
About this trial
This is an interventional treatment trial for Nitric Oxide focused on measuring Electrical Impedance Tomography, Acute Respiratory Distress Syndrome, Inhaled Nitric Oxide, Ventilation-Perfusion mismatch, Lung recruitment
Eligibility Criteria
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
Sites / Locations
- Far Eastern Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group_Use Lung recruitment
Study group_Use Lung recruitment combined inhaled Nitric oxide
Arm Description
Use the Lung recruitment,
Use the Lung recruitment combined inhaled Nitric oxide,
Outcomes
Primary Outcome Measures
V/Q mismatch
Compare the V/Q mismatch between two groups
Secondary Outcome Measures
PaO2/FiO2 ratio improvement rate
Oxygention improve rate
Full Information
NCT ID
NCT04776408
First Posted
February 23, 2021
Last Updated
January 29, 2023
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04776408
Brief Title
Potential for Inhaled Nitric Oxide and Ventilation-Perfusion Mismatch by Electrical Impedance Tomography in the ARDS Patients With Lung Recruitment
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nitric Oxide, Acute Respiratory Distress Syndrome
Keywords
Electrical Impedance Tomography, Acute Respiratory Distress Syndrome, Inhaled Nitric Oxide, Ventilation-Perfusion mismatch, Lung recruitment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Moderate to severe ARDS patient on mechanical ventilation in Far Eastern Memorial Hospital MICU
Masking
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
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group_Use Lung recruitment
Arm Type
Active Comparator
Arm Description
Use the Lung recruitment,
Arm Title
Study group_Use Lung recruitment combined inhaled Nitric oxide
Arm Type
Experimental
Arm Description
Use the Lung recruitment combined inhaled Nitric oxide,
Intervention Type
Device
Intervention Name(s)
Lung recruitment combined inhaled Nitric oxide
Intervention Description
Ventilator combined inhaled Nitric oxide and Electrical Impedance Tomography monitor the V/Q mismatch
Intervention Type
Device
Intervention Name(s)
Lung recruitment
Intervention Description
Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch
Primary Outcome Measure Information:
Title
V/Q mismatch
Description
Compare the V/Q mismatch between two groups
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
PaO2/FiO2 ratio improvement rate
Description
Oxygention improve rate
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hou T Chang, Doctor
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ping H Wang, Bachelor
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mei Y Chang, Master
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei county
State/Province
Banqiao Dist
ZIP/Postal Code
22060
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Still in the research phase.May be consider later
Citations:
PubMed Identifier
31160064
Citation
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.
Results Reference
background
PubMed Identifier
32697482
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31160064/
Description
Measurement of relative lung perfusion with electrical impedance and positron emission tomography: an experimental comparative study in pigs
URL
https://pubmed.ncbi.nlm.nih.gov/32697482/
Description
Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019
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Potential for Inhaled Nitric Oxide and Ventilation-Perfusion Mismatch by Electrical Impedance Tomography in the ARDS Patients With Lung Recruitment
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