Nitric OxideNCT04776408
Potential for Inhaled Nitric Oxide and Ventilation-Perfusion Mismatch by Electrical Impedance Tomography in the ARDS Patients With Lung Recruitment
A study testing Lung recruitment combined inhaled Nitric oxide and Lung recruitment in people with Nitric Oxide and Acute Respiratory Distress Syndrome, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Nitric Oxide, Acute Respiratory Distress Syndrome
- What is being tested?
- Lung recruitment combined inhaled Nitric oxide and Lung recruitment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Nitric Oxide, Acute Respiratory Distress Syndrome
- Being tested
- Lung recruitment combined inhaled Nitric oxide, Lung recruitment
- Keywords
- Electrical Impedance Tomography, Acute Respiratory Distress Syndrome, Inhaled Nitric Oxide, Ventilation-Perfusion mismatch, Lung recruitment
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung recruitment combined inhaled Nitric oxideDevice
Ventilator combined inhaled Nitric oxide and Electrical Impedance Tomography monitor the V/Q mismatch
Lung recruitmentDevice
Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch
| Study group | Role | What they receive |
|---|---|---|
| Control group_Use Lung recruitment | Active comparator | Use the Lung recruitment, Receives: Device: Lung recruitment |
| Study group_Use Lung recruitment combined inhaled Nitric oxide | Experimental | Use the Lung recruitment combined inhaled Nitric oxide, Receives: Device: Lung recruitment combined inhaled Nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
V/Q mismatch
Compare the V/Q mismatch between two groups
Measured: 15 minutes
Secondary outcomes (1)
PaO2/FiO2 ratio improvement rate
Oxygention improve rate
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start29 Apr 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nitric OxideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Moderate to severe ARDS patient on mechanical ventilation in Far Eastern Memorial Hospital MICU
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hou T Chang, Doctor, Study director, Far Eastern Memorial HospitalPing H Wang, Bachelor, Study director, Far Eastern Memorial HospitalMei Y Chang, Master, Study director, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776408
- Sponsor's protocol ID
- 109200-F
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Still in the research phase.May be consider later
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.
PubMed 31160064Mauri 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.
PubMed 32697482
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04776408
- Acronym / sponsor ID
- 109200-F
- Conditions
- Nitric Oxide, Acute Respiratory Distress Syndrome
- Keywords
- Electrical Impedance Tomography, Acute Respiratory Distress Syndrome, Inhaled Nitric Oxide, Ventilation-Perfusion mismatch, Lung recruitment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Moderate to severe ARDS patient on mechanical ventilation in Far Eastern Memorial Hospital MICU
| Arm | Type | Receives |
|---|---|---|
| Control group_Use Lung recruitment | Active comparator | Device: Lung recruitmentUse the Lung recruitment, |
| Study group_Use Lung recruitment combined inhaled Nitric oxide | Experimental | Device: Lung recruitment combined inhaled Nitric oxideUse the Lung recruitment combined inhaled Nitric oxide, |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- Hemodynamic instability or severe COPD, pulmonary embolism
- Acute brain injury, seizure attack, AMI, AIDS, severe arrhythmia
- On pacemaker
- Pregnant
- Thoracic trauma or burn injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung recruitment combined inhaled Nitric oxideVentilator combined inhaled Nitric oxide and Electrical Impedance Tomography monitor the V/Q mismatch | Device | Study group_Use Lung recruitment combined inhaled Nitric oxide |
| Lung recruitmentVentilator and Electrical Impedance Tomography monitor the V/Q mismatch | Device | Control group_Use Lung recruitment |
Primary outcome
V/Q mismatch
Time frame: 15 minutes
Compare the V/Q mismatch between two groups
1 secondary outcome
PaO2/FiO2 ratio improvement rate
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 31160064Bluth 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.
- Background: PubMed 32697482Mauri 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.
- Measurement of relative lung perfusion with electrical impedance and positron emission tomography: an experimental comparative study in pigsLink provided by the sponsor.
- Potential for Lung Recruitment and Ventilation-Perfusion Mismatch in Patients With the Acute Respiratory Distress Syndrome From Coronavirus Disease 2019Link provided by the sponsor.
- Individual participant dataSharing planned: No. Still in the research phase.May be consider later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hou T Chang, Doctor study director
Far Eastern Memorial Hospital
Ping H Wang, Bachelor study director
Far Eastern Memorial Hospital
Mei Y Chang, Master study director
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung recruitment combined inhaled Nitric oxide and Lung recruitment in people with Nitric Oxide and Acute Respiratory Distress Syndrome, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
V/Q mismatch (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04776408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.