Clinical trial NCT02723123: Non-invasive Support in Extremely Preterm Infants
Official title: Respiratory Behaviour of Extremely Preterm Infants Receiving Non-invasive Respiratory Support During the Immediate Post-extubation Period
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Noninvasive Ventilation
Keywords: CPAP
NIPPV
Extubation failure
Cardiorespiratory behaviour
NIV-NAVA
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-03-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: A large proportion of extremely preterm infants are mechanically ventilated through the use of endotracheal intubation. However, clinicians try to avoid intubation due to the complications that may arise from being mechanically ventilated such as ventilator associated pneumonia (VAP), pulmonary hemorrhage, air leak etc. In order to the prevent these complications, clinicians accelerate weaning and provide non-invasive respiratory support. The most commonly used type of non-invasive respiratory support following extubation is nasal continuous positive airway pressure (NCPAP). NCPAP has been shown to improve oxygenation, reduce airway resistance, increase tidal volume, stabilize chest wall and maintain functional residual capacity. In addition to NCPAP, nasal intermittent positive pressure ventilation (NIPPV) has become a popular choice as a post-extubation respiratory support mode. However, there is a lack of knowledge regarding the effects of synchronization between the infant's own spontaneous respiratory efforts and ventilator inflations.

Synchronization, especially during non-invasive ventilation, is difficult to achieve in preterm infants due to their rapid respiratory rates, short inspiratory times, periodic breathing, leaks and small tidal volumes. Previous studies have used devices such as an abdominal capsule to allow for synchronization while the infant is receiving NIPPV. The abdominal capsule itself is prone to incorrect placement, time delays and ineffective synchronization. Neurally Activated Ventilatory Assistance (NAVA) is a new technology that can be used during invasive and non-invasive ventilation. In this novel mode, the electrical activity of the diaphragm, called EAdi, is detected be electrodes inserted at the tip of a specialized nasogastric tube. The EAdi represents the patient's inherent neural respiratory drive. The ventilator assists each spontaneous breath by delivering pressure that is linearly proportional to the EAdi. The mechanical breath is initiated at the start of diaphragmatic contraction and maintained until the EAdi is at 60 to 70% of the peak pressure generated. Therefore, the inspiratory time, expiratory time and peak inflation pressure are all controlled and determined by the patient, providing patient-ventilator synchrony.

Eligibility criteria: 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

Primary outcomes:
measure: Differences on cardiorespiratory behaviour in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA
timeFrame: Immediate post-extubation period (30 minutes after extubation)
Secondary outcomes:
measure: Differences on in patient-ventilator interaction in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA
timeFrame: Immediate post-extubation period (30 minutes after extubation)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
Study officials:
affiliation: McGill University
name: Guilherme Sant'Anna, MD
role: STUDY_CHAIR
affiliation: McGill University
name: Wissam Shalish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Robert Kearney, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Karen Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Doina Precup, PhD
role: PRINCIPAL_INVESTIGATOR
References: