Effort of Breathing Guided Ventilator Protocol
Condition: Ventilators, Mechanical; Work of Breathing
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      This pilot study tests the feasibility of using a computerized ventilator management protocol
      seeking to encourage lung protective ventilation during the acute phase of ventilation, and
      esophageal manometry based titration of ventilator settings during the weaning phase of
      ventilation, for children with acute respiratory failure. The investigators hypothesize that
      such an approach will reduce time on mechanical ventilation, largely by preserving diaphragm
      muscle function.
    

Detailed description: 
      Objectives: This pilot study will help refine a computer based ventilator management protocol
      which will be used in both acute and weaning phases of ventilation for children with acute
      respiratory failure. The acute phase protocol is an adaptation of the Acute Respiratory
      Distress Syndrome Network protocol for pediatrics, and the weaning phase involves an
      esophageal manometry guided weaning protocol based on effort of breathing. The investigators
      seek to test the safety and feasibility of the protocol recommendations and the software
      system , and help determine the potential effect size of the intervention to determine
      feasibility of a randomized controlled trial. They also seek to determine the feasibility and
      reproducibility of serial diaphragm ultrasound measurements on mechanically ventilated
      children.

      Study Population: All children intubated and mechanically ventilated in the Children's
      Hospital Los Angeles Pediatric ICU with an anticipated length of intubation > 48 hours will
      be eligible, with some exclusion criteria based on ability to perform the measurements.

      Study methodology: After consent, an esophageal catheter will be placed. A software
      management tool for ventilator management will be placed at the bedside for each enrolled
      patient, and recommendations regarding changing ventilator support will be provided to the
      clinicians every several hours during both acute and weaning phases. When ventilator support
      is below a threshold, recommendations will be made to perform spontaneous breathing trials.
      The clinicians will ultimately decide whether to accept or reject the recommendations, and
      will evaluate the patient before each potential change to the ventilator. The acceptance or
      rejection of recommendations will be tracked, and used to refine the intervention. Daily
      diaphragm ultrasound measurements will also be obtained to monitor diaphragm thickness and
      contractile activity.

      Follow up: Clinical outcomes will be followed while in the ICU including re-intubation,
      medications administered, and ICU length of stay. No follow up after ICU discharge is
      planned.

      Analysis plans: Data will be used to refine the intervention, test the acceptability of
      protocol recommendations to bedside providers, and determine sample size estimates for a
      follow up randomized controlled trial. These analyses will be descriptive. A pilot of 40
      patients is anticipated.
    

Intervention name(s): Ventilator protocol; Esophageal Catheter
Intervention type(s): Other; Device
Intervention description(s): Open loop ventilator management by a computer based protocol; Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; ventilator weaning