Respiratory FailureEdi-PTPNCT02154542
Study to Improve Treatments and Follow-up of Children Who Need Respiratory Support
A study testing Neurovent Monitor XIII in people with Respiratory Failure, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the duration of ventilation, mortality, length… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Neurovent Monitor XIII
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Up to 18 years
- Child on invasive mechanical ventilation for which the withdrawal phase was determined by the clinician in charge of the patient
- Consent obtained
Who cannot join
- Post conceptional age < 37 weeks
- Contraindication to changing or insertion of nasogastric tube (esophageal malformation, gastrointestinal bleeding, esophageal varices)
- Curarised patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Measurement of Respiratory Work Using Diaphragm Electrical Activity in Infant and Children During Weaning
Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the duration of ventilation, mortality, length of ICU stay and health costs. The practitioner should ask the benefit of the continuation of this IV daily and adapting it, to limit complications. The evaluation of the work of breathing is a key element in understanding the pathophysiology of respiratory distress but is also a key element in improving the management of ventilatory support and the adjustment of ventilatory parameters .
It has been shown that there is an increased work of breathing in all children admitted in ICU for clinical acute respiratory distress that is significantly reduced by ventilatory support. There is probably a relationship that should be proportional between the work of breathing ( PTP ) resulting in respiratory request triggered by the respiratory drive and the electrical activity of the diaphragm ( Edi ) .
The validation of this correlation PTP / Edi has a direct impact on the monitoring of ventilated patients with the ability to monitor the physiological factor while maintaining a classical treatment of children by simply monitoring Edi without additional invasive device .
Read the detailed description
It is very important that the respirators detect the child's breathing efforts. This makes it possible to reduce the pressure used by the respirator to push air into the child's lungs, to improve oxygen distribution throughout the child's body and reduce the level of sedation Typical systems do not really detect changes in breathing efforts, but rather volumes of exhaled air. Therefore, the respirator is not always synchronized with patient's respiration and there may be a delay between breathing cycles and the ventilator's, which leads to an increase in his respiratory effort.
Assessing respiratory work is a key element in improving the management of ventilatory support and the adaptation of ventilatory parameters. At this time, routinely used measurements do not include quantitative measurement of the respiratory work, as it requires the installation of probes with pressure heads.
There is new technology known as Neurally Adjusted Ventilatory Assist (NAVA) that employs a probe inserted into the stomach that detects the electrical activity of the diaphragm (primary breathing muscle).The probe is connected to the respirator and triggers respiratory assistance through diaphragm electrical activity, thereby ensuring respiratory assistance that is adapted to the child's needs. This artificial ventilatory mode has already been widely used during invasive ventilation in adults and for short periods of time in infants, children and premature newborn. Health Canada has authorized the use of the NAVA ventilatory mode within the context of this study.
The aim of this study is to assess whether there is a relation between the electrical activity of the diaphragm and respiratory work. This will enable the use of diaphragm activity that can be recorded daily at the child's bedside as an element of respiratory monitoring and allow early detection of dangerously high or low respiratory levels.
The study plans to recruit 20 patients at the CHU Sainte-Justine, which is the only hospital taking part in the study.
The investigators will replace the probe placed in the stomach of any child under artificial ventilation with the study probe. The probe is changed regularly as part of routine care. The study probe is equipped with microelectrodes to measure diaphragm activity as well as a very fine balloon to measure pressure. The patient's diaphragm activity and respiratory work will then be assessed over a 2-hour period under two different ventilatory conditions (the NAVA mode and the conventional mode) in random order. The investigators will perform a random draw to determine the initial ventilator mode.
The two periods, each lasting 60 minutes, will proceed as follows:
The conventional ventilation period: the ventilation parameters are adjusted by the care team based on the practices in effect within the department; the researcher will not intervene.
The NAVA mode period: the initial settings are determined to target support that is similar to that prescribed by the care team and after that are adjusted based on NAVA clinical protocol in effect within the department During the final 30 minutes of each period, a computer will record ventilation parameters, diaphragm activity and respiratory effort. These data will be recorded using a simple connection to the ventilator and no change in the patient's equipment will be required.
If the study naso-gastric tube is still in place at the time of extubation, 3 additional measurements (10 minutes each) will be taken to assess changes in diaphragm activity and respiratory work around extubation:
An initial recording during the hour before extubation; A second one at extubation; and; A third one two hours after extubation.
The investigators will follow patient progress for another 48 hours after extubation.
Data will be collected in the child's medical record for the purposes of the study.
- Conditions
- Respiratory Failure
- Being tested
- Neurovent Monitor XIII
- Keywords
- Nava, Mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurovent Monitor XIIIDevice
Also called Health Canada approval number: 209799
| Study group | Role | What they receive |
|---|---|---|
| Experimental A | Active comparator | NAVA then standard mode Receives: Device: Neurovent Monitor XIII |
| Experimental B | Active comparator | Standard mode then NAVA Receives: Device: Neurovent Monitor XIII |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between diaphragmatic electrical activity (edi) and the work of breathing assessed by measuring the oesophageal pressure time product (PTP) during mechanical ventilation weaning
Measured: within 12 hours of extubation
Secondary outcomes (2)
Measure of the asynchrony index (AI) during NAVA and standard mode. Comparison of AI and PTP between NAVA and standard mode
Measured: within 12 hours of extubation
Rate profile of Edi and PTP as a predictor of success or failure of the withdrawal
Measured: within 48 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Guillaume Emeriaud, St. Justine's Hospital
- Investigators
- Guillaume Emeriaud, MD, PhD, Principal investigator, St. Justine's HospitalPhilippe Jouvet, MD, PhD, Principal investigator, St. Justine's HospitalSandrine Essouri, M.D, Ph.D., Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154542
- Sponsor's protocol ID
- CHUSJ-3688
- Acronym
- Edi-PTP
- Status last verified
- Nov 2015
- First submitted
- 13 May 2014
- Last updated
- 23 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Measurement of Respiratory Work Using Diaphragm Electrical Activity in Infant and Children During Weaning
- ClinicalTrials.gov ID
- NCT02154542
- Acronym / sponsor ID
- Edi-PTP / CHUSJ-3688
- Conditions
- Respiratory Failure
- Keywords
- Nava, Mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical ventilation is a vital therapeutic support, widely used in pediatric intensive care. Invasive ventilation (IV) is associated with risk of major complications ( nosocomial pneumonia, secondary pulmonary barotrauma injuries, pneumothorax) , which can increase : the duration of ventilation, mortality, length of ICU stay and health costs. The practitioner should ask the benefit of the continuation of this IV daily and adapting it, to limit complications. The evaluation of the work of breathing is a key element in understanding the pathophysiology of respiratory distress but is also a key element in improving the management of ventilatory support and the adjustment of ventilatory parameters .
It has been shown that there is an increased work of breathing in all children admitted in ICU for clinical acute respiratory distress that is significantly reduced by ventilatory support. There is probably a relationship that should be proportional between the work of breathing ( PTP ) resulting in respiratory request triggered by the respiratory drive and the electrical activity of the diaphragm ( Edi ) .
The validation of this correlation PTP / Edi has a direct impact on the monitoring of ventilated patients with the ability to monitor the physiological factor while maintaining a classical treatment of children by simply monitoring Edi without additional invasive device .
Detailed description
It is very important that the respirators detect the child's breathing efforts. This makes it possible to reduce the pressure used by the respirator to push air into the child's lungs, to improve oxygen distribution throughout the child's body and reduce the level of sedation Typical systems do not really detect changes in breathing efforts, but rather volumes of exhaled air. Therefore, the respirator is not always synchronized with patient's respiration and there may be a delay between breathing cycles and the ventilator's, which leads to an increase in his respiratory effort.
Assessing respiratory work is a key element in improving the management of ventilatory support and the adaptation of ventilatory parameters. At this time, routinely used measurements do not include quantitative measurement of the respiratory work, as it requires the installation of probes with pressure heads.
There is new technology known as Neurally Adjusted Ventilatory Assist (NAVA) that employs a probe inserted into the stomach that detects the electrical activity of the diaphragm (primary breathing muscle).The probe is connected to the respirator and triggers respiratory assistance through diaphragm electrical activity, thereby ensuring respiratory assistance that is adapted to the child's needs. This artificial ventilatory mode has already been widely used during invasive ventilation in adults and for short periods of time in infants, children and premature newborn. Health Canada has authorized the use of the NAVA ventilatory mode within the context of this study.
The aim of this study is to assess whether there is a relation between the electrical activity of the diaphragm and respiratory work. This will enable the use of diaphragm activity that can be recorded daily at the child's bedside as an element of respiratory monitoring and allow early detection of dangerously high or low respiratory levels.
The study plans to recruit 20 patients at the CHU Sainte-Justine, which is the only hospital taking part in the study.
The investigators will replace the probe placed in the stomach of any child under artificial ventilation with the study probe. The probe is changed regularly as part of routine care. The study probe is equipped with microelectrodes to measure diaphragm activity as well as a very fine balloon to measure pressure. The patient's diaphragm activity and respiratory work will then be assessed over a 2-hour period under two different ventilatory conditions (the NAVA mode and the conventional mode) in random order. The investigators will perform a random draw to determine the initial ventilator mode.
The two periods, each lasting 60 minutes, will proceed as follows:
The conventional ventilation period: the ventilation parameters are adjusted by the care team based on the practices in effect within the department; the researcher will not intervene.
The NAVA mode period: the initial settings are determined to target support that is similar to that prescribed by the care team and after that are adjusted based on NAVA clinical protocol in effect within the department During the final 30 minutes of each period, a computer will record ventilation parameters, diaphragm activity and respiratory effort. These data will be recorded using a simple connection to the ventilator and no change in the patient's equipment will be required.
If the study naso-gastric tube is still in place at the time of extubation, 3 additional measurements (10 minutes each) will be taken to assess changes in diaphragm activity and respiratory work around extubation:
An initial recording during the hour before extubation; A second one at extubation; and; A third one two hours after extubation.
The investigators will follow patient progress for another 48 hours after extubation.
Data will be collected in the child's medical record for the purposes of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental A | Active comparator | Device: Neurovent Monitor XIIINAVA then standard mode |
| Experimental B | Active comparator | Device: Neurovent Monitor XIIIStandard mode then NAVA |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Up to 18 years
- Child on invasive mechanical ventilation for which the withdrawal phase was determined by the clinician in charge of the patient
- Consent obtained
Key exclusion criteria (3 listed)
- Post conceptional age < 37 weeks
- Contraindication to changing or insertion of nasogastric tube (esophageal malformation, gastrointestinal bleeding, esophageal varices)
- Curarised patient
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 |
|---|---|---|
| Neurovent Monitor XIIIAlso: Health Canada approval number: 209799 | Device | Experimental A, Experimental B |
Primary outcome
The correlation between diaphragmatic electrical activity (edi) and the work of breathing assessed by measuring the oesophageal pressure time product (PTP) during mechanical ventilation weaning
Time frame: within 12 hours of extubation
2 secondary outcomes
Measure of the asynchrony index (AI) during NAVA and standard mode. Comparison of AI and PTP between NAVA and standard mode
Time frame: within 12 hours of extubation
Rate profile of Edi and PTP as a predictor of success or failure of the withdrawal
Time frame: within 48 hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
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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.
Guillaume Emeriaud, MD, PhD principal investigator
St. Justine's Hospital
Philippe Jouvet, MD, PhD principal investigator
St. Justine's Hospital
Sandrine Essouri, M.D, Ph.D. principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurovent Monitor XIII in people with Respiratory Failure, run by St. Justine's Hospital at 1 site in Canada.
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 23 Nov 2015. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The correlation between diaphragmatic electrical activity (edi) and the work of breathing assessed by measuring the oesophageal pressure time product (PTP) during mechanical ventilation weaning (time frame: within 12 hours of extubation). 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 23 Nov 2015.