Ventilators, MechanicalEOBventNCT02989246
Effort of Breathing Guided Ventilator Protocol
A study testing Ventilator protocol and Esophageal Catheter in people with Ventilators, Mechanical and Work of Breathing, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 37 weeks to 18 years
- Conditions the study is for
- Ventilators, Mechanical, Work of Breathing
- What is being tested?
- Ventilator protocol and Esophageal Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
Official title: Effort of Breathing Guided Ventilator Management for Children Using Pressure Rate Product: a Pilot Study
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.
Read the 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.
- Conditions
- Ventilators, Mechanical, Work of Breathing
- Being tested
- Ventilator protocol, Esophageal Catheter
- Keywords
- pediatrics, ventilator weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator protocolOther
Open loop ventilator management by a computer based protocol
Esophageal CatheterDevice
Esophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Ventilator protocol; Device: Esophageal Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start1 Feb 2015
- Primary completion18 Oct 2017
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventilators, MechanicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robinder Khemani, Children's Hospital Los Angeles
- Investigators
- Robinder Khemani, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989246
- Sponsor's protocol ID
- CHLA-14-00473
- Acronym
- EOBvent
- Status last verified
- Oct 2024
- First submitted
- 6 Dec 2016
- Last updated
- 30 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effort of Breathing Guided Ventilator Management for Children Using Pressure Rate Product: a Pilot Study
- ClinicalTrials.gov ID
- NCT02989246
- Acronym / sponsor ID
- EOBvent / CHLA-14-00473
- Conditions
- Ventilators, Mechanical, Work of Breathing
- Keywords
- pediatrics, ventilator weaning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2015
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Ventilator protocol, Device: Esophageal CatheterVentilator 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 |
Who may qualify
- Ages
- 37 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator protocolOpen loop ventilator management by a computer based protocol | Other | Intervention Arm |
| Esophageal CatheterEsophageal manometry measurements of patient effort of breathing will be used to guide the protocol recommendations | Device | Intervention Arm |
Primary outcome
Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Ventilators, Mechanical
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
Not yet recruitingObservational study
Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
Not yet recruitingObservational study
Impact of Inspiratory Effort and Patient-Ventilator Interaction During the Transition Phase
Mechanically Ventilated Patients, Acute Respiratory Failure (ARF)
Not yet recruitingObservational study
Intra-Abdominal Pressure, Respiratory Mechanics, and Ventilator Liberation After Emergency Major Laparotomy
Intra-Abdominal Hypertension, Respiratory Mechanics
Not yet recruiting
Closed Versus Open Endotracheal Suctioning and Ventilator-Associated Pneumonia in Severe Traumatic Brain Injury
Ventilator-associated Pneumonia, Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robinder Khemani, MD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilator protocol and Esophageal Catheter in people with Ventilators, Mechanical and Work of Breathing, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Protocol Recommendations Which Are Accepted by the Clinical Provider (time frame: With each protocol recommendation, approximately every 4 hours during the course of mechanical ventilation (up to 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.