- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02723123
Non-invasive Support in Extremely Preterm Infants
Respiratory Behaviour of Extremely Preterm Infants Receiving Non-invasive Respiratory Support During the Immediate Post-extubation Period
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Monica Bhuller, BSc.
- Phone Number: 514-705-2288
- Email: monica.bhuller@mail.mcgill.ca
Study Contact Backup
- Name: Guilherme Sant'Anna, MD
- Phone Number: 23489 514-412-4400
- Email: guilherme.santanna@mcgill.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Recruiting
- Montreal Children's Hospital
-
Contact:
- Guilherme Sant'Anna, MD, PhD
- Phone Number: 23489 514-412-4400
- Email: guilherme.santanna@mcgill.ca
-
Contact:
- Wissam Shalish, MD
- Phone Number: 224452 514-412-4452
- Email: wissam.shalish@mail.mcgill.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CPAP
CPAP will be provided for a approximately 45 minutes.
|
Biological signals: ECG, RIP, SpO2 and Pulse rate will be recorded during the interventions and analyzed offline.
|
Experimental: NIPPV
NIPPV will be provided for a approximately 45 minutes.
|
Biological signals: ECG, RIP, SpO2 and Pulse rate will be recorded during the interventions and analyzed offline.
|
Experimental: NIV-NAVA
NIV-NAVA will be provided for a approximately 45 minutes.
|
Biological signals: ECG, RIP, SpO2 and Pulse rate will be recorded during the interventions and analyzed offline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences on cardiorespiratory behaviour in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA
Time Frame: Immediate post-extubation period (30 minutes after extubation)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences on in patient-ventilator interaction in extremely preterm infants receiving CPAP, NIPPV and NIV-NAVA
Time Frame: Immediate post-extubation period (30 minutes after extubation)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Guilherme Sant'Anna, MD, McGill University
- Principal Investigator: Wissam Shalish, MD, McGill University
- Principal Investigator: Robert Kearney, PhD, McGill University
- Principal Investigator: Karen Brown, MD, McGill University
- Principal Investigator: Doina Precup, PhD, McGill University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NIVNAVA 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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