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Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

Primary Purpose

Respiratory Failure, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transpulmonary pressure guided positive end expiratory pressure
standard positive end expiratory pressure
Sponsored by
University of Mississippi Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Failure focused on measuring Transpulmonary pressure, Respiratory failure, Obesity, Invasive mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Mississippi Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transpulmonary pressure guided positive end expiratory pressure

Standard positive end expiratory pressure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ventilator free days
Number of ventilator free days

Secondary Outcome Measures

Mortality
Number of patients who died during the study
Days on invasive mechanical ventilation
Number of days patient spent on mechanical ventilation
Re-intubation rate
Percentage of patients who were re-intubated after extubation failure
Number of tracheostomies
Number of patients who received tracheostomies
PEEP at extubation
the amount of positive end expiratory pressure set on the ventilator prior to extubation
Intensive care unit length of stay
Number of days spent in the intensive care unit
Hospital length of stay
Number of days spent in the hospital

Full Information

First Posted
September 2, 2022
Last Updated
April 11, 2023
Sponsor
University of Mississippi Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05530434
Brief Title
Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity
Official Title
Transpulmonary Pressure Guided Weaning From Invasive Mechanical Ventilation in Obese Patients With Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Obesity
Keywords
Transpulmonary pressure, Respiratory failure, Obesity, Invasive mechanical ventilation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transpulmonary pressure guided positive end expiratory pressure
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard positive end expiratory pressure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
transpulmonary pressure guided positive end expiratory pressure
Intervention Description
Positive end expiratory pressure will be titrated to achieve a transpulmonary pressure of 0-2 cm H2O
Intervention Type
Other
Intervention Name(s)
standard positive end expiratory pressure
Intervention Description
Positive end expiratory pressure will be set to a standard 5-8 cm H2O by the clinician for spontaneous breathing trials
Primary Outcome Measure Information:
Title
Ventilator free days
Description
Number of ventilator free days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
Number of patients who died during the study
Time Frame
30 days
Title
Days on invasive mechanical ventilation
Description
Number of days patient spent on mechanical ventilation
Time Frame
30 days
Title
Re-intubation rate
Description
Percentage of patients who were re-intubated after extubation failure
Time Frame
30 days
Title
Number of tracheostomies
Description
Number of patients who received tracheostomies
Time Frame
30 days
Title
PEEP at extubation
Description
the amount of positive end expiratory pressure set on the ventilator prior to extubation
Time Frame
30 days
Title
Intensive care unit length of stay
Description
Number of days spent in the intensive care unit
Time Frame
30 days
Title
Hospital length of stay
Description
Number of days spent in the hospital
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith E Sloan, MD
Phone
601-815-9634
Email
mesloan@umc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Wilhelm, DO
Phone
601-984-5650
Email
awilhelm@umc.edu
Facility Information:
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Wilhelm
Email
awilhelm@umc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

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