Respiration, ArtificialNavPed-InvNCT01193023
Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients
A study testing Pressure Support and NAVA in people with Respiration, Artificial, 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 invasive mechanical ventilation in pediatric patients breathing under pressure support. Read more about this study
- Who is it for?
- Ages 4 weeks to 12 years
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- Pressure Support and NAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2010to Jun 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation
Who cannot join
- Non treated pneumothorax
- Hemodynamic instability
- At least 2 hours following the admission in the PICU in post cardiac surgery
- 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
Show all 10Show fewer
- 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
- Patients with a pacemaker
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University hospital of Geneva
Geneva, 1211
Laurence Vignaux, 0041223727448, laurence.vignaux@hcuge.ch
Peter Rimenberger, 00412237 24 730, peter.rimensberger@hcuge.ch
About this study
The purpose of this study is to document the prevalence and type of asynchronies incidence during invasive mechanical ventilation in pediatric patients breathing under pressure support.
And to observe the impact of adjusting the expiratory trigger setting on asynchronies, 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 invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.
Ventilation parameters in PS 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 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% 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 ventilation will be recorded during 20 minutes.
The 2 sessions, Pressure support and Nava, will be recorded consecutively.
- Conditions
- Respiration, Artificial
- Being tested
- Pressure Support, 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
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure SupportOther
Ventilation under pressure support
NAVADevice
Ventilation under NAVA
| Study group | Role | What they receive |
|---|---|---|
| Pressure support | Active comparator | in this arm, pressure support will be recorded under 3 conditions:
* with the initial Expiratory Trigger Setting (ETS)
* with ETS +10%
* with ETS -10% Receives: Other: Pressure Support |
| NAVA | Experimental | 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. Receives: Device: 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 Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +10% and -10%, 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 posted1 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Peter Rimensberger, MD, Principal investigator, Ûniversity hospital of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193023
- Sponsor's protocol ID
- HUG-matped 09-253
- Acronym
- NavPed-Inv
- Status last verified
- Aug 2010
- First submitted
- 31 Aug 2010
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-ventilator Asynchrony During Mechanical Invasive Assisted-ventilation in Pediatric Patients
- ClinicalTrials.gov ID
- NCT01193023
- Acronym / sponsor ID
- NavPed-Inv / HUG-matped 09-253
- Conditions
- Respiration, Artificial
- 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
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 1 Sep 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 invasive mechanical ventilation in pediatric patients breathing under pressure support.
And to observe the impact of adjusting the expiratory trigger setting on asynchronies, 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 invasive ventilation and to start PSV will follow the usual practice guidelines of the unit.
Ventilation parameters in PS 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 10% below the initial set value, and will be recorded the following 5 minutes after stabilization and secondly increasing it of 10% 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 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 |
|---|---|---|
| Pressure support | Active comparator | Other: Pressure Supportin this arm, pressure support will be recorded under 3 conditions: * with the initial Expiratory Trigger Setting (ETS) * with ETS +10% * with ETS -10% |
| NAVA | Experimental | Device: 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. |
Who may qualify
- Ages
- 4 weeks to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all consecutive patients from 4 weeks to 12 years (post natal interm infants) admitted to the pediatric intensive care unit (PICU) and receiving mechanical ventilation in pressure support ventilation
Key exclusion criteria (10 listed)
- Non treated pneumothorax
- Hemodynamic instability
- At least 2 hours following the admission in the PICU in post cardiac surgery
- FiO2 > 0.6
- Poor short term prognosis (defined as a high risk of death in the next seven days)
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 |
|---|---|---|
| Pressure SupportVentilation under pressure support | Other | Pressure support |
| NAVAVentilation under NAVA | Device | 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 Pressure support (3 phases: 3 levels of expiratory trigger setting, initial, +10% and -10%, 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2010.
Related trials for Respiration, Artificial
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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
Ûniversity hospital of 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 Pressure Support and NAVA in people with Respiration, Artificial, 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 10 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: status not confirmed, as of the sponsor's last update on 1 Sep 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Vignaux (0041223727448, laurence.vignaux@hcuge.ch), or a site near the patient. 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 1 Sep 2010.