Respiratory FailureNCT05530434
Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity
A study testing transpulmonary pressure guided positive end expiratory pressure and standard positive end expiratory pressure in people with Respiratory Failure and Obesity, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
This study will look at whether accounting for the amount of pressure generated by the chest wall and abdomen in a obese patient, using a measurement called transpulmonary pressure, can help shorten the amount of time patients spend on the ventilator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Obesity
- What is being tested?
- transpulmonary pressure guided positive end expiratory pressure and standard positive end expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 14 Apr 2026
- 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
- on invasive mechanical ventilation for respiratory failure for < 48 hours
- obese class II or higher (BMI greater than or equal to 35.0 kg/m2)
Who cannot join
- contraindications to esophageal balloon catheter placement including esophageal, nasofacial, gastrointestinal abnormalities and platelets <10,000/microliter
- known pleural disease such as persistent pneumothorax, pleural effusion, or pleurodesis
- neuromuscular disease
- requires chronic mechanical ventilation prior to enrollment
- severe neurologic injury
- known difficult airway
- life expectance is less than 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Transpulmonary Pressure Guided Weaning From Invasive Mechanical Ventilation in Obese Patients With Respiratory Failure
This study will look at whether accounting for the amount of pressure generated by the chest wall and abdomen in a obese patient, using a measurement called transpulmonary pressure, can help shorten the amount of time patients spend on the ventilator. By decreasing the amount of time patients spend on the ventilator, they are less likely to develop complications such as infections, weakness or more procedures.
Read the detailed description
Managing obese patients on the ventilator can be difficult due to the changes in their respiratory mechanics with little evidence as to best practices. This research will assess the utility of transpulmonary pressures in guiding mechanical ventilation in obese patients. This study with specifically look at whether using transpulmonary pressure guided positive end expiratory pressure (PEEP) titration for ventilation and spontaneous breathing trials (SBT) will shorten the time to liberation for obese patients on invasive mechanical ventilation for respiratory failure. The transpulmonary pressures will be calculated daily for all patients. Patients will also be assessed daily for readiness for SBT. In the intervention group, subjects' PEEP will be titrated to achieve an end expiratory transpulmonary pressure of 0-2 cm H2O. This PEEP will be used for the SBT and clinicians will be encouraged to keep their patients on this PEEP after the SBT if they are not extubated. In the control group, patients will also be assessed daily for SBT readiness but will be managed with standard set pressures of 5 to 10 cm H2O of PEEP and 5 to 8 cm H2O of pressure above PEEP. The primary team can perform a T piece trial prior to extubation as clinically indicated.
- Conditions
- Respiratory Failure, Obesity
- Being tested
- transpulmonary pressure guided positive end expiratory pressure, standard positive end expiratory pressure
- Keywords
- Transpulmonary pressure, Respiratory failure, Obesity, Invasive mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transpulmonary pressure guided positive end expiratory pressureOther
Positive end expiratory pressure will be titrated to achieve a transpulmonary pressure of 0-2 cm H2O
standard positive end expiratory pressureOther
Positive end expiratory pressure will be set to a standard 5-8 cm H2O by the clinician for spontaneous breathing trials
| Study group | Role | What they receive |
|---|---|---|
| Transpulmonary pressure guided positive end expiratory pressure | Experimental | Patients in this group will have the positive end expiratory pressure on the ventilator set to a transpulmonary pressure of 0-2 cm H2O during ventilation and spontaneous breathing trials. Receives: Other: transpulmonary pressure guided positive end expiratory pressure |
| Standard positive end expiratory pressure | Active comparator | Patients in this groups will have the positive end expiratory pressure on the ventilator set by the clinician during ventilation and set to a standard positive end expiratory pressure of 5-8 cm H2O during spontaneous breathing trials. Receives: Other: standard positive end expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days
Number of ventilator free days
Measured: 30 days
Secondary outcomes (7)
Mortality
Number of patients who died during the study
Measured: 30 days
Days on invasive mechanical ventilation
Number of days patient spent on mechanical ventilation
Measured: 30 days
Re-intubation rate
Percentage of patients who were re-intubated after extubation failure
Measured: 30 days
Number of tracheostomies
Number of patients who received tracheostomies
Measured: 30 days
PEEP at extubation
the amount of positive end expiratory pressure set on the ventilator prior to extubation
Measured: 30 days
Intensive care unit length of stay
Number of days spent in the intensive care unit
Measured: 30 days
Hospital length of stay
Number of days spent in the hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start11 Apr 2022
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Why it stopped: Slow enrollment
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.
- 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
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meredith E. Sloan, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530434
- Sponsor's protocol ID
- UMMC-IRB-2022-301
- Status last verified
- May 2026
- First submitted
- 2 Sep 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Pressure Guided Weaning From Invasive Mechanical Ventilation in Obese Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT05530434
- Acronym / sponsor ID
- UMMC-IRB-2022-301
- Conditions
- Respiratory Failure, Obesity
- Keywords
- Transpulmonary pressure, Respiratory failure, Obesity, Invasive mechanical ventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 7 Sep 2022 (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.
This study will look at whether accounting for the amount of pressure generated by the chest wall and abdomen in a obese patient, using a measurement called transpulmonary pressure, can help shorten the amount of time patients spend on the ventilator. By decreasing the amount of time patients spend on the ventilator, they are less likely to develop complications such as infections, weakness or more procedures.
Detailed description
Managing obese patients on the ventilator can be difficult due to the changes in their respiratory mechanics with little evidence as to best practices. This research will assess the utility of transpulmonary pressures in guiding mechanical ventilation in obese patients. This study with specifically look at whether using transpulmonary pressure guided positive end expiratory pressure (PEEP) titration for ventilation and spontaneous breathing trials (SBT) will shorten the time to liberation for obese patients on invasive mechanical ventilation for respiratory failure. The transpulmonary pressures will be calculated daily for all patients. Patients will also be assessed daily for readiness for SBT. In the intervention group, subjects' PEEP will be titrated to achieve an end expiratory transpulmonary pressure of 0-2 cm H2O. This PEEP will be used for the SBT and clinicians will be encouraged to keep their patients on this PEEP after the SBT if they are not extubated. In the control group, patients will also be assessed daily for SBT readiness but will be managed with standard set pressures of 5 to 10 cm H2O of PEEP and 5 to 8 cm H2O of pressure above PEEP. The primary team can perform a T piece trial prior to extubation as clinically indicated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpulmonary pressure guided positive end expiratory pressure | Experimental | Other: transpulmonary pressure guided positive end expiratory pressurePatients in this group will have the positive end expiratory pressure on the ventilator set to a transpulmonary pressure of 0-2 cm H2O during ventilation and spontaneous breathing trials. |
| Standard positive end expiratory pressure | Active comparator | Other: standard positive end expiratory pressurePatients in this groups will have the positive end expiratory pressure on the ventilator set by the clinician during ventilation and set to a standard positive end expiratory pressure of 5-8 cm H2O during spontaneous breathing trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- on invasive mechanical ventilation for respiratory failure for < 48 hours
- obese class II or higher (BMI greater than or equal to 35.0 kg/m2)
Key exclusion criteria (7 listed)
- contraindications to esophageal balloon catheter placement including esophageal, nasofacial, gastrointestinal abnormalities and platelets <10,000/microliter
- known pleural disease such as persistent pneumothorax, pleural effusion, or pleurodesis
- neuromuscular disease
- requires chronic mechanical ventilation prior to enrollment
- severe neurologic 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 |
|---|---|---|
| transpulmonary pressure guided positive end expiratory pressurePositive end expiratory pressure will be titrated to achieve a transpulmonary pressure of 0-2 cm H2O | Other | Transpulmonary pressure guided positive end expiratory pressure |
| standard positive end expiratory pressurePositive end expiratory pressure will be set to a standard 5-8 cm H2O by the clinician for spontaneous breathing trials | Other | Standard positive end expiratory pressure |
Primary outcome
Ventilator free days
Time frame: 30 days
Number of ventilator free days
7 secondary outcomes
Mortality
Time frame: 30 days
Days on invasive mechanical ventilation
Time frame: 30 days
Re-intubation rate
Time frame: 30 days
Number of tracheostomies
Time frame: 30 days
PEEP at extubation
Time frame: 30 days
Intensive care unit length of stay
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transpulmonary pressure guided positive end expiratory pressure and standard positive end expiratory pressure in people with Respiratory Failure and Obesity, run by University of Mississippi Medical Center 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 May 2026. 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 was stopped early (reason given: Slow enrollment). 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?
Ventilator free days (time frame: 30 days). 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 14 May 2026.