Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation

Obesity Clinical Trial

Official title:

Effects of Different PEEP Levels on Work of Breathing in Morbidly Obese Patients Prior to and After Extubation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02492113
• Other study ID #: WOBTRIAL
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: Lorenzo Berra, MD
• Phone: 6176437733
• Email: lberra[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to define at the bedside the "Titrated-PEEP" level for obese patients that increases the likelihood of extubation and ventilator liberation.

The investigators hypothesized that a titrated level of PEEP ("Titrated-PEEP") during SBT will keep the lung recruited, maintain oxygenation, and decrease the work of breathing resulting in successful ventilator liberation. In addition, post-extubation the investigators hypothesize that these patients will require noninvasive ventilatory support in the form of CPAP at the level of "titrated-PEEP" used during the SBT.

Description:

The high WOB of morbidly obese patients is associated with respiratory muscle fatigue and failure in extubation. The investigators hypothesized that the use of a titrated PEEP level prior to and after extubation might improve successful extubation rates and avoid re-intubation.

In this study, patients will be awake and ventilated in the pressure support ventilation (PSV) mode. The investigators will apply different PEEP levels to measure WOB, transpulmonary pressure and characterize the response of the respiratory system to increasing or decreasing PEEP. The "Titrated-PEEP" will be identified as the PEEP level associated with the lowest value of respiratory system elastance and an end expiratory transpulmonary pressure of 2 cmH2O. Then the participants will have two spontaneous breathing trials; one at PEEP 0-5 cmH2O, and the other at the "Titrated-PEEP" level, with PSV=0 and FiO2 unchanged. After extubation, the participants will first receive CPAP set at "Titrated-PEEP", then spontaneous breathing. Electrical impedance tomography (EIT), respiratory system mechanics and gas exchange will be recorded during the study.

The investigators believe that the real-time determination of "Titrated-PEEP" can guide the treatment of mechanical ventilation and give us a better understanding of the physiology and pathophysiology of morbidly obese patients. As a result, this study will improve patient safety; reduce the duration of mechanical ventilation, complications and healthcare costs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intubated and mechanically ventilated;

• Weaning from mechanical ventilation;

• BMI = 35 kg/m2 with waist circumference > 88 cm for women; waist circumference > 102 cm for men.

• A well functioning arterial line.

Exclusion Criteria:

• Known presence of esophageal varices

• Recent esophageal trauma or surgery

• Severe thrombocytopenia (PTL = 5,000/mm3)

• Severe coagulopathy (INR = 4)

• Presence of pneumothorax

• Pregnancy

• Pacemaker and/or internal cardiac defibrillator

Related Conditions & MeSH terms

• Obesity
• Respiratory Aspiration

Intervention

Procedure:
• Positive end-expiratory pressure (PEEP)
"Titrated-PEEP". After recruitment maneuver and decremental PEEP trial, the "Titrated-PEEP" is identified. Patients will have two spontaneous breathing trials (SBTs). In this arm, patients will have SBT at "Titrated-PEEP", with the PSV=0 and FiO2 unchanged.
• ZEEP
After recruitment maneuver and decremental PEEP trial, the "Titrated-PEEP" is identified. Patients will have two spontaneous breathing trials (SBTs). In this arm, patients will have SBT at PEEP = 0-5 cmH2O, with the PSV=0 and FiO2 unchanged.

Locations

Country	Name	City	State
United States	Massachussets General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in WOB at titrated PEEP levels vs. ZEEP level	Work Of Breathing measured as J/L and J/min during a Spontaneous Breathing Trial at titrated PEEP vs. Work Of Breathing measured as J/L and J/min during a Spontaneous Breathing Trial at zero PEEP	24 hours
Secondary	Gas Exchange - Oxygenation	Difference in oxygenation as measured in mmHg of PaO2/FiO2 during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.	24 hours
Secondary	Gas Exchange - Arterial carbon dioxide	Difference in arterial carbon dioxide as measured in mmHg (PaCO2) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.	24 hours
Secondary	Respiratory Mechanics - Compliance	Difference in Compliance, measured as ml/cmH2O, of the respiratory system, lungs and chest wall during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.	24 hours
Secondary	Gas Volume Distribution	Difference in the images of Electric Impedance Tomography measured as relative variation of regional impedance (deltaZ) (i.e. distribution of ventilation) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.	24 hours
Secondary	Hemodynamics - Blood pressure	Changes in arterial blood pressures (BP, mmHg) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.	24 hours
Secondary	Hemodynamics - Heart rate	Changes in heart rate (HR, bpm) during a Spontaneous Breathing Trial at titrated PEEP and at zero PEEP.	24 hours