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Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients (NavPed-NI)

Patient-ventilator Asynchrony During Mechanical Non-Invasive Assisted-ventilation in Pediatric Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01238757
Acronym
NavPed-NI
Enrollment
7
Registered
2010-11-11
Start date
2010-06-30
Completion date
2011-09-30
Last updated
2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Respiratory Failure

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*

Brief 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. * 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.

Interventions

OTHERNon-invasive Ventilation under Pressure Support

Non-invasive Ventilation under Pressure Support: 15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order

OTHERNon-Invasive ventilation under NAVA

20 min session under non-invasive ventilation with NAVA

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Weeks to 5 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
asynchronies12 monthsAsynchronies 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026