Effort of Breathing Guided Ventilator Protocol

NCT02989246 | Completed Results

• 1 other identifier: CHLA-14-00473
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventilators, Mechanical; Work of Breathing

Keywords

pediatrics; ventilator weaning

Outcome Measures

Primary Outcomes (1)

• Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider

  The investigators will track the percentage of recommendations which are accepted by providers, as well as the reasons why recommendations were not accepted

  With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Ventilator management using the proposed protocol in both acute and weaning phases. Patients will be managed according the the Ventilator protocol using the esophageal catheter for the weaning phase

Other: Ventilator protocol; Device: Esophageal Catheter

Interventions

Ventilator protocol OTHER

Open loop ventilator management by a computer based protocol

Intervention Arm

Esophageal Catheter DEVICE

Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations

Intervention Arm

Eligibility Criteria

• Age: 37 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Intubated and mechanically ventilated patients in the Children's Hospital Los Angeles Pediatric ICU
• Anticipated length of intubation \> 48 hours.
• The primary attending physician approves use of the protocol on the patient.

You may not qualify if:

• Corrected gestational age less than 37 weeks
• Contraindications to nasoesophageal catheter placement (nasopharyngeal or esophageal abnormalities) or Respiratory Inductance Plethysmography bands (abdominal wall defects such as omphalocele).
• Significant lower airway obstruction (asthma or bronchiolitis), confirmed by ventilator spirometry

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Results Point of Contact

• Title: Dr Robinder Khemani, Associate Director of Research ACCM
• Organization: Children's Hospital Los Angeles

rkhemani@chla.usc.edu

323-361-2376

Study Officials

• Robinder Khemani, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 12, 2016
• Study Start: February 1, 2015
• Primary Completion: October 18, 2017
• Study Completion: December 1, 2018
• Last Updated: October 30, 2024
• Results First Posted: October 22, 2021

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)