Transpulmonary Pressure Guided Mechanical Ventilation Weaning in Obesity

Obesity Clinical Trial

Official title:

Transpulmonary Pressure Guided Weaning From Invasive Mechanical Ventilation in Obese Patients With Respiratory Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530434
• Other study ID #: UMMC-IRB-2022-301
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: University of Mississippi Medical Center
• Contact: Meredith E Sloan, MD
• Phone: 601-815-9634
• Email: mesloan[@]umc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: April 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Mississippi Medical Center	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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