Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

NCT ID: NCT05530434

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2025-04-30

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.

Conditions

Respiratory Failure; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

transpulmonary pressure guided positive end expiratory pressure

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

standard positive end expiratory pressure

Intervention Type: OTHER

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

Interventions

transpulmonary pressure guided positive end expiratory pressure

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Meredith E. Sloan

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meredith E Sloan, MD

Role: CONTACT

mesloan@umc.edu

601-815-9634

Andrew Wilhelm, DO

Role: CONTACT

awilhelm@umc.edu

601-984-5650

Facility Contacts

Andrew Wilhelm

Role: primary

awilhelm@umc.edu

Other Identifiers

UMMC-IRB-2022-301

Identifier Type: -

Identifier Source: org_study_id