Noninvasive Ventilation Clinical Trial
Official title:
Respiratory Behaviour of Extremely Preterm Infants Receiving Non-invasive Respiratory Support During the Immediate Post-extubation Period
NCT number | NCT02723123 |
Other study ID # | NIVNAVA 01 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | January 2019 |
Non-invasive respiratory support is routinely provided to extremely preterm infants following disconnection from mechanical ventilation, in the form of continuous positive airway pressure (CPAP) or non-invasive positive pressure ventilation (NIPPV). However, these modes remain sub-optimal due to lack of synchronization and upper airway defensive mechanisms that potentially hinder their effectiveness. Non-invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) is a novel mode that may overcome some of these problems but has not been investigated in this population. Investigators hypothesize that there will be significant differences in cardiorespiratory behavior in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA during the immediate post-extubation period.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | January 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - birth weight under 1250 grams receiving invasive mechanical ventilation Exclusion Criteria: - infants with major congenital anomalies, congenital heart defects, neuromuscular disease, diaphragmatic paralysis or palsy, diagnosed phrenic nerve injury, esophageal perforation, hemodynamic instability as well as infants on interpose, narcotics or sedative agents |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Children's Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Guilherme Sant'Anna, MD |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences on cardiorespiratory behaviour in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA | Cardiorespiratory signals (ECG, thoraco-abdominal movements, oxygen saturation and TcPCO2), and ventilator signals (pressure and EAdi waveforms, tidal volume, MAP, PIP, PEEP, and FiO2) will continuously be measured throughout the recordings. Analysis of these signals will be performed offline. From these cardiorespiratory signals, behaviour will be analyzed by calculations of: cardiorespiratory variability, respiratory pauses, thoraco-abdominal asynchrony, respiratory movement artifacts and regular breathing pattern. Cardiorespiratory behavior will be calculated using the instantaneous power estimate of all respiratory and cardiac signals computed. To this end, each of the continuous metrics will be squared and averaged over a symmetric, two-sided window of length. For example, the correlation between respiratory and heart rates will be estimated by averaging the product fmax*hmax over the same window. |
Immediate post-extubation period (30 minutes after extubation) | |
Secondary | Differences on in patient-ventilator interaction in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA | Patient-ventilator interaction which will be analyzed by calculating the following parameters: Trigger delay, cycling off delay, number of breaths with premature cycling off, asynchrony index, wasted inspiratory efforts, relationship and proportionality between ventilator assist and patient respiratory demand. Despite the different units of measure for the aforementioned parameters, these values together will represent an accurate description of the interaction between the patient and the ventilator. These parameters will compared between the three modes. |
Immediate post-extubation period (30 minutes after extubation) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02845076 -
Weaning From Noninvasive Ventilation
|
N/A | |
Recruiting |
NCT05008211 -
Information-Motivation-Behavioral Skills Model-based Intervention to Domiciliary Non-invasive Ventilation of Patients
|
N/A | |
Completed |
NCT03250416 -
Management of Noninvasive Ventilation in Hypoxemic Patients
|
||
Not yet recruiting |
NCT03687424 -
Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults?
|
N/A | |
Not yet recruiting |
NCT03687385 -
The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients
|
N/A | |
Recruiting |
NCT01791335 -
NIV and Glottis-diaphragm Synchrony
|
N/A | |
Recruiting |
NCT04165382 -
Development, Implementation and Evaluation of a Clinical Practice Guideline for Care of Preterm Infants Receiving Non-invasive Ventilation (NIV)
|
N/A | |
Completed |
NCT04912544 -
Facilitating Patient Communication During Noninvasive Ventilation
|
N/A | |
Active, not recruiting |
NCT03499470 -
Structured Discharge and Follow-up Protocol for COPD Patients Receiving LTOT and NIV
|
N/A | |
Not yet recruiting |
NCT05964244 -
Impact of Noninvasive With Expiratory Washout on Respiratory Rate of Patients With Acute Hypercapnic Respiratory Failure
|
N/A | |
Recruiting |
NCT03053973 -
The Effects of Nocturnal Non-invasive Ventilation in Stable COPD
|
N/A | |
Terminated |
NCT04413643 -
NIV for COPD: Hospital to Home
|
N/A | |
Completed |
NCT03151317 -
Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV
|
||
Completed |
NCT03607357 -
High Flow Nasal Oxygen and Acute Left Heart Failure
|
N/A | |
Withdrawn |
NCT02615834 -
Chest Pressure for Intubated Peds Patients
|
N/A | |
Not yet recruiting |
NCT02383719 -
Mask Comfort Feasibility
|
N/A | |
Not yet recruiting |
NCT06260202 -
Nutrition Under Noninvasive Ventilation
|
||
Completed |
NCT03876873 -
Effect of Head Rotation on Efficacy of Face Mask Ventilation in Anesthetized Obese (BMI ≥ 35) Adults
|
N/A | |
Completed |
NCT02267291 -
Impact of Non-invasive Positive Pressure Ventilation on Cardiac Function and Echocardiographic Parameters
|
N/A | |
Not yet recruiting |
NCT04904484 -
A Safety Assessment of the iZephyr Hood for NIV in COVID-19 Patients
|
N/A |