Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Respiratory Failure
• Intervention / Treatment: Other: transpulmonary pressure guided positive end expiratory pressure; Other: standard positive end expiratory pressure

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transpulmonary pressure guided positive end expiratory pressure; 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.	Other: transpulmonary pressure guided positive end expiratory pressure; Positive end expiratory pressure will be titrated to achieve a transpulmonary pressure of 0-2 cm H2O
Active Comparator: Standard positive end expiratory pressure; 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.	Other: standard positive end expiratory pressure; Positive end expiratory pressure will be set to a standard 5-8 cm H2O by the clinician for spontaneous breathing trials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator free days	Number of ventilator free days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Number of patients who died during the study	30 days
Days on invasive mechanical ventilation	Number of days patient spent on mechanical ventilation	30 days
Re-intubation rate	Percentage of patients who were re-intubated after extubation failure	30 days
Number of tracheostomies	Number of patients who received tracheostomies	30 days
PEEP at extubation	the amount of positive end expiratory pressure set on the ventilator prior to extubation	30 days
Intensive care unit length of stay	Number of days spent in the intensive care unit	30 days
Hospital length of stay	Number of days spent in the hospital	30 days

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2022
• Primary Completion (Actual): April 14, 2026
• Study Completion (Actual): April 14, 2026

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Respiratory failure; Invasive mechanical ventilation; Transpulmonary pressure
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Respiratory Insufficiency
• Other Study ID Numbers: UMMC-IRB-2022-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No