Transpulmonary Pressures in Mechanical Ventilated Patient... | NCT02309190

Studies
Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity

NCT02309190

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Dec 12, 2024Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Mechanical Ventilation Complication
Respiratory Insufficiency

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Dec 1, 2024Actual

Completion Date

Dec 1, 2024Actual

First Submitted Date

Sep 16, 2014

First Submission Date that Met QC Criteria

Dec 2, 2014

First Posted Date

Dec 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2024

Last Update Posted Date

Dec 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rosa Estrada Y Martin, Associate Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
transpulmonary pressures		Esophageal balloon to measure transpulmonary pressures. PEEP adjustment as per transpulmonary pressures.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transpulmonary pressure	We will record the changes in transpulmonary pressure after adjusting PEEP (measure in cmH2O).	one year

Secondary Outcomes

Measure	Description	Time Frame
hemodynamics	we will review hemodynamic changes while adjusting PEEP (BP, HR).	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

both gender
morbid obesity
hemodynamically stable

Exclusion Criteria:

pregnant patients
cirrhotic patients with esophageal varicose

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adults mechanically ventilated with morbid obesity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas - HSC at Houston		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided