Titration of PEEP During Mechanical Ventilation in Patients With ARDS Using Electrical Impedance Tomography.

NCT02596178 | Withdrawn DMC

• 1 other identifier: IRB-P00017859
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Lung units that participate in gas exchange are known as 'recruited' lung. Patients with lung injury suffer from a proportion of units that do not participate in gas exchange (i.e. the derecruited lung), which results in impaired gas exchange and induces an inflammatory cascade. The level of PEEP is often coupled to indices of oxygenation such as PaO2, PaO2 to FIO2 ratio, or oxygen index. Currently, two strategies are widely accepted and considered equivocal, one strategy using a lower PEEP level coupled to a certain oxygen requirement, the other using a higher PEEP level. The primary purpose of this study is to demonstrate the safety and efficacy of an electrical impedance tomography (EIT) PEEP titration protocol designed to recruit collapsed lung in children with ARDS and properly maintain lung volumes by setting an optimal PEEP level. A safety system has been developed using the ARDSnet FIO2/PEEP High (upper threshold limit) and Low (lower threshold limit) algorithm. Efficacy will be defined as an improvement in lung volume as assessed by electrical impedance tomography, lung compliance and by an improvement in markers of gas exchange. Safety will be defined as the incidence of barotrauma and hemodynamic consequences that occur during the protocol. Those results will be compared to incidences of barotrauma and hemodynamic compromise within the ARDS literature. Knowledge gained from this pilot will be instrumental in developing an EIT imagine guided protocol which will allow us to conduct future RCTs utilizing EIT technology

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• Safety - measured by Barotrauma

  3 days

• Safety - measured by Gas Exchange

  3 days

Study Arms (1)

EIT Guided PEEP Therapy

EXPERIMENTAL

Device: Electrical Impedance Tomography

Interventions

Electrical Impedance Tomography DEVICE

Electrical impedance tomography capitalizes on changes in electrical impendence between air-filled versus tissue or fluid-filled spaces in order to characterize and quantify regional distribution of lung volume at the bedside.

EIT Guided PEEP Therapy

Eligibility Criteria

• Age: 2 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• a. The Berlin definition of ARDS36 i. Blood gas criteria:
• Mild: PaO2/FiO2 ratio of 201-300,
• Moderate: PaO2/FIO2 ratio of 101-200
• Severe: PaO2/FIO2 ratio of \< 100 ii. Acute onset (within 1 week) of bilateral (patchy, diffuse, or homogeneous) infiltrates consistent with pulmonary edema on chest radiograph, and iii. No evidence of left atrial hypertension
• \. Conventional lung protective mechanical ventilation Chest radiograph within the first 12h after the study recruitment

You may not qualify if:

• Meets the above criteria for ARDS for \> 72 hours
• \< 2 years of age or chest circumference \< 55 cm.
• Clinically recognized airways disease (e.g. anatomic or reactive airway disease by history, treatment or flow graphics)
• Uncuffed endotracheal tube in place
• Airleak
• Congenital heart disease
• Hemodynamically significant heart disease
• Congenital diaphragmatic hernia
• Pulmonary fibrosis
• Restrictive lung disease (other than ARDS)
• Cystic fibrosis
• Significant pulmonary hypertension requiring treatment (eg iNO, sildenafil, flolan)
• Severe brain injury with no intracranial pressure monitor or external ventricular drain in place
• Extra-corporeal life support
• Patients with unstable spinal injuries or diseases

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 4, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

US (1)