Real-time Effort Driven VENTilator Management

Summary

This study is a Phase II controlled clinical trial that will obtain comprehensive, serial assessments of respiratory muscle strength and architecture to understand the evolution of ventilator-induced respiratory muscle weakness in critically ill children, and test whether a novel computer-based approach (Real-time Effort Driven ventilator management (REDvent)) can preserve respiratory muscle strength and reduce time on MV. REDvent offers systematic recommendations to reduce controlled ventilation during the acute phase of MV, and uses real-time measures from esophageal manometry to adjust supported ventilator pressures such that patient effort of breathing remains in a normal range during the ventilator weaning phase. This phase II clinical trial is expected to enroll 276 children with pulmonary parenchymal disease, anticipated to be ventilated \> 48 hrs. Patients will be randomized to REDvent-acute vs. usual care for the acute phase of MV (interval from intubation to first spontaneous breathing trial (SBT)). Patients in either group who fail their first Spontaneous Breathing Trial (SBT), will also be randomized to REDvent-weaning vs. usual care for the weaning phase of MV (interval from first SBT to passing SBT). The primary clinical outcome is length of weaning (time from first SBT until successful passage of an SBT or extubation (whichever comes first)). Mechanistic outcomes surround multi-modal serial measures of respiratory muscle capacity (PiMax), load (resistance, compliance), effort (esophageal manometry), and architecture (ultrasound) throughout the course of MV. Upon completion, this study will provide important information on the pathogenesis and timing of respiratory muscle weakness during MV in children and whether this weakness can be mitigated by promoting more normal patient effort during MV via the use of REDvent. This will form the basis for a larger, Phase III multi-center study, powered for key clinical outcomes such as 28-day Ventilator Free Days.

Conditions

• Ventilation Therapy; Complications
• Diaphragm Disease
• Pediatric Respiratory Diseases

Interventions

OTHER

Computerized Ventilator Protocol

Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.

DIAGNOSTIC_TEST

Esophageal Manometry

Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure

DIAGNOSTIC_TEST

Respiratory Inductance Plethysmography (RIP)

RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials

DIAGNOSTIC_TEST

Diaphragm Ultrasound

Daily measurement of diaphragm thickness and diaphragm contractile activity

DIAGNOSTIC_TEST

Maximal Inspiratory Pressure

Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Los Angeles

  lead OTHER

Principal Investigators

• Robinder G Khemani, MD, MsCI · Children's Hospital Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Days

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-21

Primary Completion

2024-04-01

Completion

2024-06-20

Countries

• United States

Study Locations