Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

University of Zurich50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Infant, Newborn, Diseases Intubation Complication

Interventions

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: first intubation attempt

Secondary Outcomes

Incidence of desaturation

Number of desaturations (SpO2 \<80 %) between baseline and the begin of the first intubation attempt

Time frame: 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

Time frame: 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 \[%\]

Time frame: 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 \[bpm\]

Time frame: baseline to begin of first intubation attempt

Incidence of desaturation

Number of desaturations (SpO2 \<80 %) during first intubation attempt

Time frame: first intubation attempt

Incidence of bradycardia

Number of bradycardia (Hf \<100 bpm) during first intubation attempt

Time frame: first intubation attempt

Peripheral oxygen saturation

Mean oxygen saturation over time during first intubation attempt, SpO2 \[%\]

Time frame: first intubation attempt

Heart rate

Mean heart rate over time during first intubation attempt, HR \[bpm\]

Time frame: 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.

Time frame: first intubation attempt

Duration of desaturation during first intubation attempt

Time of SpO2 spent below 80% during the first intubation attempt

Time frame: 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.

Time frame: first intubation attempt

Duration of bradycardia during first intubation attempt

Time of HR spent below 100 bpm during the first intubation attempt

Time frame: first intubation attempt

Duration of intubation attempt(s)

Time from baseline to successful intubation including all intubation attempts, \[sec\]

Time frame: overall intubation procedure

Number of intubation attempts

Total number of intubation attempts to successful intubation, \[n\]

Time frame: overall intubation procedure

Number of disconnections from ventilator circuit

Total number of disconnections from ventilator circuit between baseline and end of intubation attempt(s), \[n\]

Time frame: overall intubation procedure

Incidence of cardiac compressions

Incidence of cardiac compressions within one hour after first intubation attempt, \[n\]

Time frame: Within one hour of first intubation attempt

Incidence of epinephrine administration

Incidence of epinephrine administration within one hour after first intubation attempt, \[n\]

Time frame: Within one hour of first intubation attempt

Incidence of pneumothorax requiring drainage

Incidence of pneumothorax requiring drainage within 24 hours after first intubation attempt, \[n\]

Time frame: Within 24 hours of first intubation attempt

Incidence of death

Incidence of death within 24 hours after first intubation attempt, \[n\]

Time frame: Within 24 hours of first intubation attempt

Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes