Obesity, Respiratory Failure
Conditions
Keywords
Transpulmonary pressure, Respiratory failure, Obesity, Invasive mechanical ventilation
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.
Interventions
OTHERtranspulmonary pressure guided positive end expiratory pressure
Positive end expiratory pressure will be titrated to achieve a transpulmonary pressure of 0-2 cm H2O
OTHERstandard 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
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free days | 30 days | Number of ventilator free days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of tracheostomies | 30 days | Number of patients who received tracheostomies |
| 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed