Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

Study Overview
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Brief Summary
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The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. The primary aims are: Successful nasal intubation at the first attempt without physiological instability. Comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the SHINE-Trial in Australia. Participants will be intubated according to our standard intubation procedure using non-invasive ventilation (NIV) delivered through a nasopharyngeal tube.

Official Title
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The IntubAID Study - Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

Conditions
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Infant, Newborn, Diseases, Intubation Complication

Intervention / Treatment
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* Procedure: Intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any neonate at the Department of Neonatology of the University Hospital Zurich undergoing endotracheal intubation in the delivery room or neonatal intensive care unit. Exclusion Criteria: Requirement for immediate endotracheal intubation as determined by the treating clinician, without time for potential application of NIPPV, e.g. active cardiopulmonary resuscitation. Contraindication to NIPPV use (e.g. congenital diaphragmatic hernia, abdominal wall defects). Oral intubation planned. Denial of parental consent and/or inability of the parents to understand the study procedures due to cognitive or linguistic reasons. Withdrawal at the discretion of the intubating clinician if he / she feels the study is interfering with a safe and optimal treatment of the patient.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: prospective single-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intubation<br>Intubation will take place according to our local standard protocol for nasal intubation using non-invasive positive pressure ventilation (NIPPV) delivered through a nasopharyngeal tube. The intubation will be video-recorded to provide a clear view of the procedure and the pulse oximeter displaying the peripheral oxygen saturation (SpO2 [%]) and heart rate (HR [bpm]). | Procedure: Intubation<br>* Intubation will take place according to our local standard protocol for nasal intubation using NIPPV delivered through a nasopharyngeal tube. The intubation will be video-recorded to provide a clear view of the procedure and the pulse oximeter displaying the SpO2 and HR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful nasal intubation at the first intubation attempt without physiological instability | Number of successful intubations at the first intubation attempt. Physiological instability is defined as the absolute decrease in SpO2 of >20% from baseline and/or bradycardia with a heart rate of <100 bpm for any duration during the first intubation attempt. Baseline is defined as the time immediately before removal of face mask or prong for placement of the nasopharyngeal tube. The intubation starts and ends with the insertion and removal of the laryngoscope blade beyond the infant's lip. | first intubation attempt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of desaturation | Number of desaturations (SpO2 <80 %) between baseline and the begin of the first intubation attempt | baseline to begin of first intubation attempt | 
| Incidence of bradycardia | Number of bradycardia (HR <100 bpm) between baseline and the begin of the first intubation attempt | baseline to begin of first intubation attempt | 
| Peripheral oxygen saturation | Mean oxygen saturation over time between baseline and the begin of the first intubation attempt, SpO2 [%] | baseline to begin of first intubation attempt | 
| Heart rate | Mean heart rate over time between baseline and the begin of the first intubation attempt, HR [bpm] | baseline to begin of first intubation attempt | 
| Incidence of desaturation | Number of desaturations (SpO2 <80 %) during first intubation attempt | first intubation attempt | 
| Incidence of bradycardia | Number of bradycardia (Hf <100 bpm) during first intubation attempt | first intubation attempt | 
| Peripheral oxygen saturation | Mean oxygen saturation over time during first intubation attempt, SpO2 [%] | first intubation attempt | 
| Heart rate | Mean heart rate over time during first intubation attempt, HR [bpm] | first intubation attempt | 
| Time to desaturation during first intubation attempt | Time [sec] between time zero and desaturation (SpO2 <80%) during the first intubation attempt. Time zero is defined as the time the laryngoscope is inserted past the infant's lips for the first intubation attempt. | first intubation attempt | 
| Duration of desaturation during first intubation attempt | Time of SpO2 spent below 80% during the first intubation attempt | first intubation attempt | 
| Time to bradycardia during first intubation attempt | Time [sec] between time zero and bradycardia (HR <100 bpm) during the first intubation attempt. | first intubation attempt | 
| Duration of bradycardia during first intubation attempt | Time of HR spent below 100 bpm during the first intubation attempt | first intubation attempt | 
| Duration of intubation attempt(s) | Time from baseline to successful intubation including all intubation attempts, [sec] | overall intubation procedure | 
| Number of intubation attempts | Total number of intubation attempts to successful intubation, [n] | overall intubation procedure | 
| Number of disconnections from ventilator circuit | Total number of disconnections from ventilator circuit between baseline and end of intubation attempt(s), [n] | overall intubation procedure | 
| Incidence of cardiac compressions | Incidence of cardiac compressions within one hour after first intubation attempt, [n] | Within one hour of first intubation attempt | 
| Incidence of epinephrine administration | Incidence of epinephrine administration within one hour after first intubation attempt, [n] | Within one hour of first intubation attempt | 
| Incidence of pneumothorax requiring drainage | Incidence of pneumothorax requiring drainage within 24 hours after first intubation attempt, [n] | Within 24 hours of first intubation attempt | 
| Incidence of death | Incidence of death within 24 hours after first intubation attempt, [n] | Within 24 hours of first intubation attempt | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Non-invasive ventilation, Non-invasive positive pressure ventilation, Continuous positive airway pressure, Mechanical ventilation, Physiological stability