NCT02492113

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2025

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

10.1 years

First QC Date

June 12, 2015

Last Update Submit

February 18, 2026

Conditions

Obesity

Keywords

Mechanical ventilationPositive end-expiratory pressureWork of breathingMorbidly obese

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Gas Exchange - Oxygenation

    24 hours

  • Gas Exchange - Arterial carbon dioxide

    24 hours

  • Respiratory Mechanics - Compliance

    24 hours

  • Gas Volume Distribution

    24 hours

  • Hemodynamics - Blood pressure

    24 hours

  • +1 more secondary outcomes

Study Arms (1)

Patients with BMI > 35

EXPERIMENTAL

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.

Procedure: Positive end-expiratory pressure (PEEP)Procedure: ZEEP

Interventions

Positive end-expiratory pressure (PEEP)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.

Patients with BMI > 35
ZEEPPROCEDURE

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.

Patients with BMI > 35

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachussets General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Robert Kacmarek, RRT, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Lorenzo Berra, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lorenzo Berra, MD, Assistant Professor, Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Harvard Medical School

Study Record Dates

First Submitted

June 12, 2015

First Posted

July 8, 2015

Study Start

November 1, 2015

Primary Completion

November 24, 2025

Study Completion

November 24, 2025

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

US(1)