Infant, Newborn, Diseases, Intubation Complication
Conditions
Keywords
Intubation, Non-invasive ventilation, Non-invasive positive pressure ventilation, Continuous positive airway pressure, Mechanical ventilation, Physiological stability
Brief summary
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.
Interventions
PROCEDUREIntubation
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.
Sponsors
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
prospective single-center study
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful nasal intubation at the first intubation attempt without physiological instability | first intubation attempt | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of desaturation | baseline to begin of first intubation attempt | Number of desaturations (SpO2 \<80 %) between baseline and the begin of the first intubation attempt |
| Peripheral oxygen saturation | baseline to begin of first intubation attempt | Mean oxygen saturation over time between baseline and the begin of the first intubation attempt, SpO2 \[%\] |
| Heart rate | baseline to begin of first intubation attempt | Mean heart rate over time between baseline and the begin of the first intubation attempt, HR \[bpm\] |
| Time to desaturation during first intubation attempt | 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. |
| Duration of desaturation during first intubation attempt | first intubation attempt | Time of SpO2 spent below 80% during the first intubation attempt |
| Time to bradycardia during first intubation attempt | first intubation attempt | Time \[sec\] between time zero and bradycardia (HR \<100 bpm) during the first intubation attempt. |
| Duration of bradycardia during first intubation attempt | first intubation attempt | Time of HR spent below 100 bpm during the first intubation attempt |
| Incidence of bradycardia | baseline to begin of first intubation attempt | Number of bradycardia (HR \<100 bpm) between baseline and the begin of the first intubation attempt |
| Number of intubation attempts | overall intubation procedure | Total number of intubation attempts to successful intubation, \[n\] |
| Number of disconnections from ventilator circuit | overall intubation procedure | Total number of disconnections from ventilator circuit between baseline and end of intubation attempt(s), \[n\] |
| Incidence of cardiac compressions | Within one hour of first intubation attempt | Incidence of cardiac compressions within one hour after first intubation attempt, \[n\] |
| Incidence of epinephrine administration | Within one hour of first intubation attempt | Incidence of epinephrine administration within one hour after first intubation attempt, \[n\] |
| Incidence of pneumothorax requiring drainage | Within 24 hours of first intubation attempt | Incidence of pneumothorax requiring drainage within 24 hours after first intubation attempt, \[n\] |
| Incidence of death | Within 24 hours of first intubation attempt | Incidence of death within 24 hours after first intubation attempt, \[n\] |
| Duration of intubation attempt(s) | overall intubation procedure | Time from baseline to successful intubation including all intubation attempts, \[sec\] |
Countries
Switzerland
Outcome results
None listed