Mechanical VentilationNCT07294768
Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure
A study testing VentCoach in people with Mechanical Ventilation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to evaluate a different way of using the mechanical ventilator device to help better protect the lungs while the patient recovers. We will compare VentCoach to the current standard mechanical ventilation techniques used in our Intensive Care Units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation
- What is being tested?
- VentCoach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to 17 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute hypoxemic and/or hypercapnic respiratory failure.
- Patients requiring intubation and mechanical ventilation for more than 24 hours.
- VentCoach protocol is specific to volume controlled continuous mandatory ventilation (S-CMV).
- Patient who are admitted to RMH 10-3/10-4 and MB 6BGF ICUs.
- Age greater than or equal to 18 years.
- Patient's legal representative should be able to provide informed consent to the study. Any participant speaking any language will be offered participation.
Who cannot join
- Intubation and mechanical ventilation for airway protection in the setting of procedures/surgeries, e.g. interventional radiology, surgery, or endoscopy.
- Intubation and mechanical ventilation due to drug overdose with expected extubation of less than 24 hours.
- Intubation and mechanical ventilation in the setting of cardiac arrest.
- Intubation and mechanical ventilation for a primary neurological etiology, e.g. increased intracranial pressure, tumor mass effect, ischemic/hemorrhagic stroke, status epilepticus, etc.
- Mechanical ventilation to be guided by esophageal balloon.
- Subject deprived of freedom, minor, subject under a legal protective measure.
- Change in end-of-life decision anticipated after enrollment (or estimated 6-month mortality rate of greater than 50%).
- Note: prone positioning is not a contraindication for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure: A Feasibility, Double Arm, Single-blinded Study
The purpose of this research is to evaluate a different way of using the mechanical ventilator device to help better protect the lungs while the patient recovers. We will compare VentCoach to the current standard mechanical ventilation techniques used in our Intensive Care Units.
- Conditions
- Mechanical Ventilation
- Being tested
- VentCoach, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentCoachOther
VentCoach, a mechanical power-guided lung protective ventilation protocol, will be used to set ventilator adjustments.
VentCoach ventilator assessments and adjustments will be performed within one hour after enrollment, and then every 4 hours thereafter
Standard of CareOther
Intubated patients will be managed per the standard of care ARDSnet-based mechanical ventilation management at Mayo Clinic, with routine RT/MD assessments, and ventilator setting changes as necessary for the treatment of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients randomized to the standard of care group will continue to receive ventilator management per the ARDSnet-based protocol Receives: Other: Standard of Care |
| VentCoach | Experimental | Patients randomized to the VentCoach group, in addition to the standard of care, will also receive intermittent ventilator setting adjustments per the VentCoach protocol Receives: Other: VentCoach; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the VentCoach protocol
Total number of patients to achieve adherence will be defined as documented reduction in mechanical power (MP) or MP less than 12 J/min, in the 16 patients assigned to the VentCoach group
Measured: 1 year
Secondary outcomes (5)
Time to removal from ventilator
Time to successful extubation, allocation to ECMO, or death reported in number of days
Measured: 1 year
Incidence of patient-ventilator dyssynchrony
Number of patients to experience patient-ventilator dyssynchrony, defined as double triggering and flow starvation
Measured: 1 year
Overall use of sedation
Total use of analgesia, converted to morphine equivalent
Measured: 1 year
Overall use of paralytics
Total number of patients to require paralytics: bolus and infusion of neuromuscular blockade outside intubation procedure
Measured: 1 year
Oxygenation index
Oxygenation index is calculated by the following equation: mean airway pressure MAP (in cmH2O) × FiO2 × 100 ÷ PaO2 and is reported as a single number.
Measured: Baseline, end of treatment (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start11 Oct 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustavo A. Cortes Puentes, Mayo Clinic
- Investigators
- Gustavo A. Cortes Puentes, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294768
- Sponsor's protocol ID
- 23-004855
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng C, Abdulla SW, Bauer PR, Rocco PRM, Marini JJ, Oeckler RA, Cortes-Puentes GA. Mechanical power guided lung protective ventilation in acute respiratory failure using the VentCoach approach. Sci Rep. 2026 Feb 18;16(1):9786. doi: 10.1038/s41598-026-40389-7.
PubMed 41708744
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Power-Guided Lung Protective Ventilation (VentCoach) in Acute Hypoxemic and/or Hypercapnic Respiratory Failure: A Feasibility, Double Arm, Single-blinded Study
- ClinicalTrials.gov ID
- NCT07294768
- Acronym / sponsor ID
- 23-004855
- Conditions
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 19 Dec 2025 (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.
The purpose of this research is to evaluate a different way of using the mechanical ventilator device to help better protect the lungs while the patient recovers. We will compare VentCoach to the current standard mechanical ventilation techniques used in our Intensive Care Units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of CarePatients randomized to the standard of care group will continue to receive ventilator management per the ARDSnet-based protocol |
| VentCoach | Experimental | Other: VentCoach, Other: Standard of CarePatients randomized to the VentCoach group, in addition to the standard of care, will also receive intermittent ventilator setting adjustments per the VentCoach protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with acute hypoxemic and/or hypercapnic respiratory failure.
- Patients requiring intubation and mechanical ventilation for more than 24 hours.
- VentCoach protocol is specific to volume controlled continuous mandatory ventilation (S-CMV).
- Patient who are admitted to RMH 10-3/10-4 and MB 6BGF ICUs.
- Age greater than or equal to 18 years.
Key exclusion criteria (8 listed)
- Intubation and mechanical ventilation for airway protection in the setting of procedures/surgeries, e.g. interventional radiology, surgery, or endoscopy.
- Intubation and mechanical ventilation due to drug overdose with expected extubation of less than 24 hours.
- Intubation and mechanical ventilation in the setting of cardiac arrest.
- Intubation and mechanical ventilation for a primary neurological etiology, e.g. increased intracranial pressure, tumor mass effect, ischemic/hemorrhagic stroke, status epilepticus, etc.
- Mechanical ventilation to be guided by esophageal balloon.
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 |
|---|---|---|
| VentCoachVentCoach, a mechanical power-guided lung protective ventilation protocol, will be used to set ventilator adjustments. VentCoach ventilator assessments and adjustments will be performed within one hour after enrollment, and then every 4 hours thereafter | Other | VentCoach |
| Standard of CareIntubated patients will be managed per the standard of care ARDSnet-based mechanical ventilation management at Mayo Clinic, with routine RT/MD assessments, and ventilator setting changes as necessary for the treatment of the patient. | Other | Standard of Care, VentCoach |
Primary outcome
Adherence to the VentCoach protocol
Time frame: 1 year
Total number of patients to achieve adherence will be defined as documented reduction in mechanical power (MP) or MP less than 12 J/min, in the 16 patients assigned to the VentCoach group
5 secondary outcomes
Time to removal from ventilator
Time frame: 1 year
Incidence of patient-ventilator dyssynchrony
Time frame: 1 year
Overall use of sedation
Time frame: 1 year
Overall use of paralytics
Time frame: 1 year
Oxygenation index
Time frame: Baseline, end of treatment (up to 14 days)
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 19 Dec 2025.
- Derived from this study: PubMed 41708744Zheng C, Abdulla SW, Bauer PR, Rocco PRM, Marini JJ, Oeckler RA, Cortes-Puentes GA. Mechanical power guided lung protective ventilation in acute respiratory failure using the VentCoach approach. Sci Rep. 2026 Feb 18;16(1):9786. doi: 10.1038/s41598-026-40389-7.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation
RecruitingObservational study
Right Ventricular Function and Respiratory Acidosis After Cardiac Surgery
Respiratory Acidosis in ICU Patients, Right Ventricular (RV) Dysfunction
RecruitingObservational study
Frequency and Severity of Respiratory Acidosis During One-lung Ventilation, a Retrospective Pilot Study to Compare Clinician Settings and Those Proposed by the VentilO Application
Thoracic, Surgery
Active, not recruitingObservational study
Evaluation of Gas Humidification Practices in Patients Under Invasive Mechanical Ventilation
Humidifier Lung, Mechanical Fragility
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Active, not recruiting
Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients
Cardiac Surgery, Mechanical Ventilation After Surgery
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.
Gustavo A. Cortes Puentes, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VentCoach in people with Mechanical Ventilation, run by Mayo Clinic 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 6 inclusion and 8 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 19 Dec 2025. 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?
Adherence to the VentCoach protocol (time frame: 1 year). 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 NCT07294768, which also lists 1 linked publication.
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 19 Dec 2025.