Pulmonary DiseaseNCT06624254
Ventilator Mode and Respiratory Physiology
An observational study of Pulmonary Disease and Respiratory Failure, run by University of California, San Diego at 1 site in United States.
Trial summary
Modern intensive care units (ICUs) are increasingly adopting newer modes of mechanical ventilation such as adaptive pressure control (APC) modes but there are limited data available regarding risks and benefits of newer modes versus traditional ventilation modes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Respiratory Failure, Respiratory Effort
- What is being tested?
- lung mechanics, respiratory drive and effort
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2024to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 intensive care unit requiring invasive mechanical ventilation for acute respiratory failure on adaptive pressure control modes of ventilation
Who may be able to join
- Admitted to ICU with acute respiratory failure
- On adaptive pressure control mode of ventilation
- Tidal volumes set between 5-8 cc/kg ideal body weight
Who cannot join
- Current use of neuromuscular blockade
- Inability to obtain consent from patient or surrogate decision maker
- Treating clinician refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California San Diego Health
La Jolla, California, 92037
About this study
Modern intensive care units (ICUs) are increasingly adopting newer modes of mechanical ventilation such as adaptive pressure control (APC) modes but there are limited data available regarding risks and benefits of newer modes versus traditional ventilation modes. APC can inadvertently deliver high tidal volumes, which maybe harmful. High tidal volumes may be unrecognized by the provider, due to the complexities of ventilator algorithms and patient interactions. The objective of this aim is to identify risk factors for excess tidal volumes in patients on adaptive pressure control.
- Being tested
- lung mechanics, respiratory drive and effort
- Medical subject headings
- Lung Diseases, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung mechanics, respiratory drive and effortOther
Patient lung mechanics and respiratory drive and effort will be measured
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Pressure Control | On adaptive pressure control mode with acute respiratory failure Receives: Other: lung mechanics, respiratory drive and effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess tidal volume
Exhaled tidal volume greater than 2cc/kg ideal body weight above intended or set tidal volume
Measured: From enrollment to end of monitoring at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start21 Sep 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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
- NCT06624254
- Sponsor's protocol ID
- 807319
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 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 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator Mode and Respiratory Physiology
- ClinicalTrials.gov ID
- NCT06624254
- Acronym / sponsor ID
- 807319
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Oct 2024 (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.
Modern intensive care units (ICUs) are increasingly adopting newer modes of mechanical ventilation such as adaptive pressure control (APC) modes but there are limited data available regarding risks and benefits of newer modes versus traditional ventilation modes. APC can inadvertently deliver high tidal volumes, which maybe harmful. High tidal volumes may be unrecognized by the provider, due to the complexities of ventilator algorithms and patient interactions. The objective of this aim is to identify risk factors for excess tidal volumes in patients on adaptive pressure control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Pressure Control | – | Other: lung mechanics, respiratory drive and effortOn adaptive pressure control mode with acute respiratory failure |
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 intensive care unit requiring invasive mechanical ventilation for acute respiratory failure on adaptive pressure control modes of ventilation
Key inclusion criteria (3 listed)
- Admitted to ICU with acute respiratory failure
- On adaptive pressure control mode of ventilation
- Tidal volumes set between 5-8 cc/kg ideal body weight
Key exclusion criteria (3 listed)
- Current use of neuromuscular blockade
- Inability to obtain consent from patient or surrogate decision maker
- Treating clinician refusal
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 mechanics, respiratory drive and effortPatient lung mechanics and respiratory drive and effort will be measured | Other | Adaptive Pressure Control |
Primary outcome
Excess tidal volume
Time frame: From enrollment to end of monitoring at 4 hours
Exhaled tidal volume greater than 2cc/kg ideal body weight above intended or set tidal volume
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 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.
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 Pulmonary Disease and Respiratory Failure, 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 3 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: enrolling by invitation, as of the sponsor's last update on 2 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Excess tidal volume (time frame: From enrollment to end of monitoring at 4 hours). 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 2 Oct 2024.