Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

NCT03951064 | Terminated Results DMC FDA Device

• 1 other identifier: 18-2010
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator. Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.

Conditions

Obesity, Morbid; Ventilator-Induced Lung Injury; Respiratory Failure

Keywords

Transpulmonary pressure; Esophageal balloon; Esophageal pressure monitoring; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Number of Ventilator-Free Days (VFD) by Day 28

  The number of days a patient is alive and free from the ventilator up to day 28.

  28 days

Secondary Outcomes (7)

• Number of Participants Reintubated

  72 hours after extubation

• ICU Length of Stay

  maximum duration of ICU stay, up to 46 days

• Hospital Length of Stay

  maximum duration of hospital stay, up to 83 days

• Number of Patients Receiving a Tracheostomy

  during mechanical ventilation, up to 28 days

• Number of Patients Extubated Early

  28 days

Study Arms (2)

Optimal PEEP

EXPERIMENTAL

The waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support).

Device: Esophageal balloon; Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation; Procedure: Intervention Weaning after Tracheostomy

Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP

ACTIVE COMPARATOR

PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP.

Device: Esophageal balloon; Procedure: Control Spontaneous Breathing Trial and Extubation; Procedure: Control Weaning after Tracheostomy

Interventions

Esophageal balloon DEVICE

All patients in both groups will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into their nare while upright (head of bed \>30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.

Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP; Optimal PEEP

Intervention Spontaneous Breathing Trial (SBT) and Extubation PROCEDURE

Patients in the Intervention group will undergo an SBT regardless of their PEEP level. The PEEP that generates a Ptp of 0 will be considered their optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP.

Optimal PEEP

Control Spontaneous Breathing Trial and Extubation PROCEDURE

Patients in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking.

Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP

Intervention Weaning after Tracheostomy PROCEDURE

Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place patients in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a patient does not have an artificial airway.

Optimal PEEP

Control Weaning after Tracheostomy PROCEDURE

The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group.

Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index greater than or equal to 40
• Acute respiratory failure requiring mechanical ventilation

You may not qualify if:

• Refusal to give consent by the subject or their legally authorized representative
• Abdominal compartment syndrome
• Chest tube for pneumothorax
• Having been on a ventilator for \>4 days
• Suspicion of or known intracranial hypertension
• Anticipated extubation within 24 hours
• Chronic ventilator dependence
• Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)
• Incarceration

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• East Carolina University: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Related Publications (2)

• Obi ON, Mazer M, Bangley C, Kassabo Z, Saadah K, Trainor W, Stephens K, Rice PL, Shaw R. Obesity and Weaning from Mechanical Ventilation-An Exploratory Study. Clin Med Insights Circ Respir Pulm Med. 2018 Sep 18;12:1179548418801004. doi: 10.1177/1179548418801004. eCollection 2018.

  PMID: 30245572 BACKGROUND

• Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.

  PMID: 30776290 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Ventilator-Induced Lung Injury; Respiratory Insufficiency

Interventions

Serum Bactericidal Test; Airway Extubation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Microbial Sensitivity Tests; Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic; Airway Management; Therapeutics

Results Point of Contact

• Title: Jackson Pettee
• Organization: University of North Carolina at Chapel Hill

jackson_pettee@med.unc.edu

984-215-6872

Study Officials

• Shannon Carson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the obvious treatment differences between the two groups, blinding of treatment group will be impossible. However, the investigators will have one outcome assessor who will have access only to the data necessary to determine the primary outcome (Ventilator-Free Days at 28-days), and this assessor will be blinded to treatment group using built-in REDCap tools.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 15, 2019
• Study Start: March 31, 2021
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: June 5, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 to 36 months following publication
• Access Criteria: Data can be obtained upon application to primary investigators. Investigators who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and execute a data use/sharing agreement with UNC.

Locations

US (2)