Respiratory FailureNCT05081895
Ventilation and Perfusion in the Respiratory System
An observational study of Respiratory Failure and Respiratory Distress Syndrome, Adult, run by University of California, San Diego at 1 site in United States.
Trial summary
Respiratory failure occurs when the lung fails to perform one or both of its roles in gas exchange; oxygenation and/or ventilation. Presentations of respiratory failure can be mild requiring supplemental oxygen via nasal cannula to more severe requiring invasive mechanical ventilation as see in acute respiratory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Respiratory Distress Syndrome, Adult, Critical Illness
- What is being tested?
- Electrical Impedance tomography and Lung mechanics and gas exchange
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 18 Dec 2023
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Human subjects admitted to the UC San Diego La Jolla Campus and Hillcrest Campus Intensive Care Units who are admitted with a pathologic condition requiring supplemental oxygen (including but not limited to nasal cannula, high flow devices), noninvasive positive pressure ventilation, mechanical ventilation.
Who may be able to join
- 18 years or older
- admitted to UC San Diego La Jolla or Hillcrest Campus Intensive Care Units
- Patient requiring supplemental oxygen (including but no limited to nasal cannula, high flow devices, noninvasive positive pressure ventilation or mechanical ventilation
Who cannot join
- <18 years
- Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin
- Patient is too unstable to position the belt/electrodes or tolerate head of bed changes
- Confirmed or suspected intracranial bleed, stroke, edema
- Active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators, neurostimulators) or if device compatibility is in doubt
- Pregnant or lactating patients as safety and efficacy for use of EIT in such cases has not been verified
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego Health
La Jolla, California, 92037
About this study
Respiratory failure occurs when the lung fails to perform one or both of its roles in gas exchange; oxygenation and/or ventilation. Presentations of respiratory failure can be mild requiring supplemental oxygen via nasal cannula to more severe requiring invasive mechanical ventilation as see in acute respiratory distress syndrome (ARDS).It is important to provide supportive care through noninvasive respiratory support devices but also to minimize risk associated with those supportive devices such as ventilator induced lung injury (VILI) and/or patient self-inflicted lung injury (P-SILI). Central to risk minimization is decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse. Patient positioning impacts ventilation/perfusion and transpulmonary pressure. Electrical impedance tomography (EIT) is an emerging technology that offers a noninvasive, real-time, radiation free method to assess distribution of ventilation at the bedside. The investigators plan to obtain observational data regarding distribution of ventilation during routine standard of care in the ICU, with special emphasis on postural changes and effects of neuromuscular blockade, to provide insight into ventilation/perfusion matching, lung mechanics in respiratory failure, other pulmonary pathological processes.
- Conditions
- Respiratory Failure, Respiratory Distress Syndrome, Adult, Critical Illness, Pulmonary Disease, Ventilator-Induced Lung Injury
- Being tested
- Electrical Impedance tomography, Lung mechanics and gas exchange
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome, Critical Illness, Lung Diseases, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Impedance tomographyDevice
Patients will be monitored with electrical impedance tomography during routine care with special attention to effects of neuromuscular blockade and postural changes.
Lung mechanics and gas exchangeOther
Patient lung mechanics and gas exchange will be monitored during routine clinical care, with specific attention to postural changes and use of neuromuscular blockade.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory failure | Not described Receives: Device: Electrical Impedance tomography; Other: Lung mechanics and gas exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of ventilation
Regional ventilation distribution differences measured through electrical impedance tomography (EIT)
Measured: change from baseline at 15 minutes and 1 hour
Secondary outcomes (4)
Lung mechanics
Lung compliance
Measured: Baseline, then at 15 minutes and 1 hour
Oxygenation
Oxygen saturation measured by pulse oximetry (SpO2) and fraction of inspired oxygen (FiO2) as well as arterial blood gas partial pressure of oxygen (PaO2). Results will be reported as either PaO2/FiO2 ratio or SpO2/FiO2 ratio (depending on availability of arterial blood gas measurements)
Measured: Up to 48 hours
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)
Partial pressure of carbon dioxide (PaCO2) (mmHg)
Measured: Up to 48 hours
Blood Gas pH
Blood Gas pH
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start19 Aug 2021
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alex Pearce, University of California, San Diego
- Investigators
- Alex Pearce, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081895
- Sponsor's protocol ID
- 210285
- Status last verified
- Dec 2024
- First submitted
- 9 Sep 2021
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Reasonable requests for IPD will be considered by the investigators
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation and Perfusion in the Respiratory System
- ClinicalTrials.gov ID
- NCT05081895
- Acronym / sponsor ID
- 210285
- Conditions
- Respiratory Failure, Respiratory Distress Syndrome, Adult, Critical Illness, Pulmonary Disease, Ventilator-Induced Lung Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 18 Oct 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.
Respiratory failure occurs when the lung fails to perform one or both of its roles in gas exchange; oxygenation and/or ventilation. Presentations of respiratory failure can be mild requiring supplemental oxygen via nasal cannula to more severe requiring invasive mechanical ventilation as see in acute respiratory distress syndrome (ARDS).It is important to provide supportive care through noninvasive respiratory support devices but also to minimize risk associated with those supportive devices such as ventilator induced lung injury (VILI) and/or patient self-inflicted lung injury (P-SILI). Central to risk minimization is decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse. Patient positioning impacts ventilation/perfusion and transpulmonary pressure. Electrical impedance tomography (EIT) is an emerging technology that offers a noninvasive, real-time, radiation free method to assess distribution of ventilation at the bedside. The investigators plan to obtain observational data regarding distribution of ventilation during routine standard of care in the ICU, with special emphasis on postural changes and effects of neuromuscular blockade, to provide insight into ventilation/perfusion matching, lung mechanics in respiratory failure, other pulmonary pathological processes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory failure | – | Device: Electrical Impedance tomography, Other: Lung mechanics and gas exchange |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Human subjects admitted to the UC San Diego La Jolla Campus and Hillcrest Campus Intensive Care Units who are admitted with a pathologic condition requiring supplemental oxygen (including but not limited to nasal cannula, high flow devices), noninvasive positive pressure ventilation, mechanical ventilation.
Key inclusion criteria (3 listed)
- 18 years or older
- admitted to UC San Diego La Jolla or Hillcrest Campus Intensive Care Units
- Patient requiring supplemental oxygen (including but no limited to nasal cannula, high flow devices, noninvasive positive pressure ventilation or mechanical ventilation
Key exclusion criteria (6 listed)
- <18 years
- Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin
- Patient is too unstable to position the belt/electrodes or tolerate head of bed changes
- Confirmed or suspected intracranial bleed, stroke, edema
- Active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators, neurostimulators) or if device compatibility is in doubt
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 |
|---|---|---|
| Electrical Impedance tomographyPatients will be monitored with electrical impedance tomography during routine care with special attention to effects of neuromuscular blockade and postural changes. | Device | Respiratory failure |
| Lung mechanics and gas exchangePatient lung mechanics and gas exchange will be monitored during routine clinical care, with specific attention to postural changes and use of neuromuscular blockade. | Other | Respiratory failure |
Primary outcome
Distribution of ventilation
Time frame: change from baseline at 15 minutes and 1 hour
Regional ventilation distribution differences measured through electrical impedance tomography (EIT)
4 secondary outcomes
Lung mechanics
Time frame: Baseline, then at 15 minutes and 1 hour
Oxygenation
Time frame: Up to 48 hours
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)
Time frame: Up to 48 hours
Blood Gas pH
Time frame: Up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: Undecided. Reasonable requests for IPD will be considered by the investigators
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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.
Alex Pearce, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure and Respiratory Distress Syndrome, Adult, run by University of California, San Diego at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 10 Dec 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distribution of ventilation (time frame: change from baseline at 15 minutes and 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.