EOBvent: Effort of Breathing Guided Ventilator Protocol

• Sponsor: Children's Hospital Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT02989246
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arm: 1
• Duration (Months): 46
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilators, Mechanical; Work of Breathing	Other: Ventilator protocol; Device: Esophageal Catheter	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effort of Breathing Guided Ventilator Management for Children Using Pressure Rate Product: a Pilot Study
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Oct 18, 2017
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm 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; Open loop ventilator management by a computer based protocol; Device: Esophageal Catheter; Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations

Outcome Measures

Primary Outcome Measures

1. Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider [With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 37 Weeks to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Los Angeles	Los Angeles	California	United States	90027

Sponsors and Collaborators

• Children's Hospital Los Angeles

Investigators

• Principal Investigator: Robinder Khemani, MD, Children's Hospital Los Angeles

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 2, 2021

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Los Angeles
• ClinicalTrials.gov Identifier: NCT02989246
• Other Study ID Numbers: CHLA-14-00473
• First Posted: Dec 12, 2016
• Last Update Posted: Oct 22, 2021
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Children's Hospital Los Angeles: pediatrics; ventilator weaning
• Additional relevant MeSH terms: Respiratory Aspiration

Study Results

Participant Flow

Pre-assignment Detail	No exclusion of patients prior to assignment to the intervention.

Arm/Group Title	Intervention Arm
Arm/Group Description	Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter Ventilator protocol: Open loop ventilator management by a computer based protocol Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations
Period Title: Overall Study
STARTED	32
COMPLETED	32
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Intervention Arm
Arm/Group Description	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 Ventilator protocol: Open loop ventilator management by a computer based protocol Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations
Overall Participants	32
Age (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	100.7
Sex: Female, Male (Count of Participants)
Female	13 40.6%
Male	19 59.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	32 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider
Description	The investigators will track the percentage of recommendations which are accepted by providers, as well as the reasons why recommendations were not accepted
Time Frame	With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm
Arm/Group Description	Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter Ventilator protocol: Open loop ventilator management by a computer based protocol Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations
Measure Participants	32
Mean (95% Confidence Interval) [percentage adherant]	76

Adverse Events

Time Frame	During ICU admission
Arm/Group Title	Intervention Arm
Arm/Group Description	Ventilator management using the proposed protocol in both acute and weaning phases. Patients were managed according the the Ventilator protocol using the esophageal catheter Ventilator protocol: Open loop ventilator management by a computer based protocol Esophageal Catheter: Esophageal manometry measurements of patient effort of breathing were used to guide the protocol recommendations
All Cause Mortality
	Intervention Arm
	Affected / at Risk (%)	# Events
Total	7/32 (21.9%)
Serious Adverse Events
	Intervention Arm
	Affected / at Risk (%)	# Events
Total	0/32 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Arm
	Affected / at Risk (%)	# Events
Total	0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.