Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

Not Applicable

Recruiting

• Conditions: Respiratory Failure; Obesity
• Interventions: Other: standard positive end expiratory pressure; Other: transpulmonary pressure guided positive end expiratory pressure

• Registration Number: NCT05530434
• Lead Sponsor: University of Mississippi Medical Center

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.

Study Timeline

• Study Start: 2022-04-11
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-03-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard positive end expiratory pressure	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.
Transpulmonary pressure guided positive end expiratory pressure	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.

Primary Outcome Measures

Name	Time	Method
Ventilator free days	30 days	Number of ventilator free days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States