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

NCT ID: NCT02492113

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2022-06-30

Brief 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.

Detailed 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.

Conditions

Obesity

Keywords

Mechanical ventilation; Positive end-expiratory pressure; Work of breathing; Morbidly obese

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with BMI > 35

ICU patients with a BMI > 35, on pressure support ventilation, scheduled for spontaneous breathing trial for evaluation of extubation

After recruitment maneuver and decremental PEEP trial, the "Titrated-PEEP" is identified. Patients will have two spontaneous breathing trials (SBTs) in randomized order. Either the patient will receive SBT at PEEP = 0-5 cmH2O, with PSV=0 and FiO2 unchanged; or the patient will perform an SBT at "Titrated-PEEP", with the PSV=0 and FiO2 unchanged.

Group Type: EXPERIMENTAL

Positive end-expiratory pressure (PEEP)

Intervention Type: PROCEDURE

"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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Kacmarek

RRT, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Kacmarek, RRT, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Lorenzo Berra, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachussets General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lorenzo Berra, MD

Role: CONTACT

Phone: 6176437733

Email: lberra@partners.org

Facility Contacts

Lorenzo Berra

Role: primary

Other Identifiers

WOBTRIAL

Identifier Type: -

Identifier Source: org_study_id