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

Withdrawn before enrolling · Not applicable

Conditions studied: Acute Respiratory Distress Syndrome

In brief

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

Key facts

Study ID: NCT02596178
Run by: Boston Children's Hospital
People needed: 0
Starts: 2016-03-01
Expected to finish: 2020-07-01
Last updated by the study team: 2019-06-05

Who can join

Age: 2 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All intubated and mechanically ventilated patients will be screened for the following inclusion criteria: 2. Age: Age 2 to 35 years 3. Arterial line 4. Have ARDS based on the following definition:
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
Body mass index > 50
Active implant such as pacemaker, ICD, or diaphragm pacer
Skin integrity issues in the area that the belt / electrodes will be placed, such as ulcers or open wounds
Dressings or chest tubes that prohibit the placement of electrodes in the proper plain.
Open chest
Flail chest within the regional plain of the belt / electrodes
If the medical team feels that the patient is not appropriate to enroll in the study based on medical, social or emotional concerns
If the patient is too unstable to position the belt / electrodes and/or transition to the Draeger ventilator

Where it is running

Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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