Respiratory FailureNavPed-NINCT01238757
Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)
A study testing Non-invasive Ventilation under Pressure Support and Non-Invasive ventilation under NAVA in people with Respiratory Failure and Mechanical Ventilation Complication, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support. Read more about this study
- Who is it for?
- Ages 4 weeks to 5 years
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation Complication
- What is being tested?
- Non-invasive Ventilation under Pressure Support and Non-Invasive ventilation under NAVA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2010to Sep 2011
- 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 4 weeks to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation
Who cannot join
- Non treated pneumothorax
- Hemodynamic instability
- FiO2 > 0.6
- Poor short term prognosis (defined as a high risk of death in the next seven days)
- contraindication for gastric tube or obtention of a reliable EMGdi signal
- Known esophageal problem (hiatal hernia, esophageal varicosities)
- Active upper gastro-intestinal bleeding or any other contraindication to the insertion of a naso-gastric tube
- Neuromuscular disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University hospital of Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients
The purpose of this study is
- to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.
- to observe the impact of adjusting the expiratory trigger setting on asynchronies during pressure support
- and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).
Read the detailed description
Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.
Criteria for initiating non-invasive ventilation will follow the usual practice guidelines of the unit.
Ventilation parameters in Non-invasive-Pressure Support will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.
One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)above the initial set value, and will be recorded the following 5 minutes after stabilization.
NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava non-invasive-ventilation will be recorded during 20 minutes.
The 2 sessions, Pressure support and Nava, will be recorded consecutively.
- Being tested
- Non-invasive Ventilation under Pressure Support, Non-Invasive ventilation under NAVA
- Keywords
- Prospective Studies, Humans, pediatric, Positive-Pressure Respiration/methods*, Respiration, Artificial/methods*, Intensive Care, Intensive Care Units/statistics & numerical data*, Respiration, Artificial/statistics & numerical data*, Patients/statistics & numerical data*, Prevalence, Respiratory Muscles/innervation, Child, Child, Preschool, Infant, Infant, Newborn, Intensive Care Units, Pediatric, Respiratory Rate*
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Ventilation under Pressure SupportOther
Also called NIV-PS/initial settings, NIV-PS/ETS-10%, NIV-PS/ETS+10%
Non-invasive Ventilation under Pressure Support:
15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order
Non-Invasive ventilation under NAVAOther
Also called Neurally Adjusted ventilatory Assist, Neural ventilation, Diaphragmatic electrical activity ventilation
20 min session under non-invasive ventilation with NAVA
| Study group | Role | What they receive |
|---|---|---|
| Non-Invasive Pressure support | Active comparator | in this arm, non-invasive pressure support will be recorded under 3 conditions:
with the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15% Receives: Other: Non-invasive Ventilation under Pressure Support |
| NAVA | Active comparator | Neurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm. Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity.
The proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support Receives: Other: Non-Invasive ventilation under NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
asynchronies
Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort.
all ventilatory parameters are recorded under non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min).
Asynchronies will be determined by measuring each ventilatory cycle of all recordings.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2011
- Study completionSep 2011
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.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter C. Rimensberger, University Hospital, Geneva
- Investigators
- Peter Rimensberger, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238757
- Sponsor's protocol ID
- HUG-matped 09-054
- Acronym
- NavPed-NI
- Status last verified
- Sep 2016
- First submitted
- 10 Nov 2010
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01238757
- Acronym / sponsor ID
- NavPed-NI / HUG-matped 09-054
- Keywords
- Prospective Studies, Humans, pediatric, Positive-Pressure Respiration/methods*, Respiration, Artificial/methods*, Intensive Care, Intensive Care Units/statistics & numerical data*, Respiration, Artificial/statistics & numerical data*, Patients/statistics & numerical data*
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Nov 2010 (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.
The purpose of this study is
- to document the prevalence and type of asynchronies incidence during non-invasive mechanical ventilation in pediatric patients breathing under pressure support.
- to observe the impact of adjusting the expiratory trigger setting on asynchronies during pressure support
- and compare these incidences with asynchronies measured in pediatric patient breathing under NAVA system (Neurally Adjusted Ventilatory Assist).
Detailed description
Two sessions will be recorded, one in PSV, one with NAVA, delivered in a random order after being sure the infant is calm and comfortable, according to his parents and/or the nurse in charge.
Criteria for initiating non-invasive ventilation will follow the usual practice guidelines of the unit.
Ventilation parameters in Non-invasive-Pressure Support will be adjusted by the clinician in charge of the patient, as usual based on clinical observation. Investigators will not interfere with ventilator settings. Ventilation will be applied via an endotracheal tube, uncuffed for the majority (if infant < 5 years), according to commonly applied guidelines in this unit.
One 15 minutes session will be recorded, after being sure the infant is calm and comfortable according to the parents and/or the nurse in charge. Then the clinician in charge of the patient will modify the ETS, first decreasing it of 15% (absolute value)below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 15% (absolute value)above the initial set value, and will be recorded the following 5 minutes after stabilization.
NAVA will be set to deliver initially the same peak pressure (comparable level of assist) than during the initial PS period. Same PEEP will be delivered in both modes. This is possible with a pre-visualization window, allowing adjustments before switching to the NAVA mode. Nava non-invasive-ventilation will be recorded during 20 minutes.
The 2 sessions, Pressure support and Nava, will be recorded consecutively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Invasive Pressure support | Active comparator | Other: Non-invasive Ventilation under Pressure Supportin this arm, non-invasive pressure support will be recorded under 3 conditions: with the initial Expiratory Trigger Setting (ETS) with ETS +15% with ETS -15% |
| NAVA | Active comparator | Other: Non-Invasive ventilation under NAVANeurally Adjusted ventilatory Assist is a ventilation mode where the ventilator is piloted by the electrical activity of the diaphragm. Ventilation is triggered and cycled off by the electrical activity of the diaphragm, the pressure delivered being proportional to this activity. The proportion named gain is chosen to obtain under NAVA the same peak pressure than during Presure Support |
Who may qualify
- Ages
- 4 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all consecutive patients from 4 weeks to 5 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical non-invasive ventilation in pressure support ventilation
Key exclusion criteria (8 listed)
- Non treated pneumothorax
- Hemodynamic instability
- FiO2 > 0.6
- Poor short term prognosis (defined as a high risk of death in the next seven days)
- contraindication for gastric tube or obtention of a reliable EMGdi signal
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 |
|---|---|---|
| Non-invasive Ventilation under Pressure SupportAlso: NIV-PS/initial settings, NIV-PS/ETS-10%, NIV-PS/ETS+10%Non-invasive Ventilation under Pressure Support: 15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order | Other | Non-Invasive Pressure support |
| Non-Invasive ventilation under NAVAAlso: Neurally Adjusted ventilatory Assist, Neural ventilation, Diaphragmatic electrical activity ventilation20 min session under non-invasive ventilation with NAVA | Other | NAVA |
Primary outcome
asynchronies
Time frame: 12 months
Asynchronies during mechanical ventilation are the following: Auto triggering, double triggering, late cycling, premature cycling and ineffective effort. all ventilatory parameters are recorded under non-invasive-Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +15% and -15%, 15 min, 5 min and 5 min respectively) and NAVA (1 phase, 20 min). Asynchronies will be determined by measuring each ventilatory cycle of all recordings.
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 14 Sep 2016.
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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.
Peter Rimensberger, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Ventilation under Pressure Support and Non-Invasive ventilation under NAVA in people with Respiratory Failure and Mechanical Ventilation Complication, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 8 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 14 Sep 2016. 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 Switzerland. 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?
asynchronies (time frame: 12 months). 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 14 Sep 2016.