Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

NCT05530434 | Terminated

• 1 other identifier: UMMC-IRB-2022-301
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Respiratory Failure

Keywords

Transpulmonary pressure; Respiratory failure; Obesity; Invasive mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilator free days

  Number of ventilator free days

  30 days

Secondary Outcomes (7)

• Mortality

  30 days

• Days on invasive mechanical ventilation

  30 days

• Re-intubation rate

  30 days

• Number of tracheostomies

  30 days

• PEEP at extubation

  30 days

Study Arms (2)

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.

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.

Other: standard positive end expiratory pressure

Interventions

transpulmonary pressure guided positive end expiratory pressure OTHER

Positive end expiratory pressure will be titrated to achieve a transpulmonary pressure of 0-2 cm H2O

Transpulmonary pressure guided positive end expiratory pressure

standard positive end expiratory pressure OTHER

Positive end expiratory pressure will be set to a standard 5-8 cm H2O by the clinician for spontaneous breathing trials

Standard positive end expiratory pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Obesity

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: April 11, 2022
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)