Mechanical Ventilation ComplicationNCT02309190
Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity
An observational study of Mechanical Ventilation Complication and Respiratory Insufficiency, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation. both gender only adults Medical intensive care patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation Complication, Respiratory Insufficiency
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 1 Dec 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults mechanically ventilated with morbid obesity
Who may be able to join
- both gender
- morbid obesity
- hemodynamically stable
Who cannot join
- pregnant patients
- cirrhotic patients with esophageal varicose
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas - HSC at Houston
Houston, Texas, 77030
About this study
The study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation.
- both gender
- only adults
- Medical intensive care patients.
Read the detailed description
We are studying adult patients with morbid obesity with respiratory failure requiring mechanical ventilation.
We are measuring transesophageal presssures to estimate ideal PEEP and evaluate hemodynamic parameters.
- Keywords
- Transpulmonary pressure - morbid obesity
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| transpulmonary pressures | Esophageal balloon to measure transpulmonary pressures. PEEP adjustment as per transpulmonary pressures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary pressure
We will record the changes in transpulmonary pressure after adjusting PEEP (measure in cmH2O).
Measured: one year
Secondary outcomes (1)
hemodynamics
we will review hemodynamic changes while adjusting PEEP (BP, HR).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study start1 Jan 2018
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Estrada Y Martin, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309190
- Sponsor's protocol ID
- HSC-MS-14-0444
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2014
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT02309190
- Acronym / sponsor ID
- HSC-MS-14-0444
- Keywords
- Transpulmonary pressure - morbid obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 5 Dec 2014 (estimated)
- 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 study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation.
- both gender
- only adults
- Medical intensive care patients.
Detailed description
We are studying adult patients with morbid obesity with respiratory failure requiring mechanical ventilation.
We are measuring transesophageal presssures to estimate ideal PEEP and evaluate hemodynamic parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transpulmonary pressures | – | –Esophageal balloon to measure transpulmonary pressures. PEEP adjustment as per transpulmonary pressures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults mechanically ventilated with morbid obesity
Key inclusion criteria (3 listed)
- both gender
- morbid obesity
- hemodynamically stable
Key exclusion criteria (2 listed)
- pregnant patients
- cirrhotic patients with esophageal varicose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transpulmonary pressure
Time frame: one year
We will record the changes in transpulmonary pressure after adjusting PEEP (measure in cmH2O).
1 secondary outcome
hemodynamics
Time frame: one year
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 12 Dec 2024.
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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?
An observational study of Mechanical Ventilation Complication and Respiratory Insufficiency, run by The University of Texas Health Science Center, Houston 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 2 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 12 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?
Transpulmonary pressure (time frame: one year). 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 12 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.