Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

Not Applicable

Recruiting

• Conditions: Infant, Newborn, Diseases; Intubation Complication
• Interventions: Procedure: Intubation

• Registration Number: NCT06139809
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2024-03-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intubation	Intubation	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 \[bpm\]).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Duration of bradycardia during first intubation attempt	first intubation attempt	Time of HR spent below 100 bpm during the first intubation attempt
Number of intubation attempts	overall intubation procedure	Total number of intubation attempts to successful intubation, \[n\]
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 desaturation	first intubation attempt	Number of desaturations (SpO2 \<80 %) during first intubation attempt
Peripheral oxygen saturation	first intubation attempt	Mean oxygen saturation over time during first intubation attempt, SpO2 \[%\]
Heart rate	first intubation attempt	Mean heart rate over time during first intubation attempt, HR \[bpm\]
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 intubation attempt(s)	overall intubation procedure	Time from baseline to successful intubation including all intubation attempts, \[sec\]
Incidence of death	Within 24 hours of first intubation attempt	Incidence of death within 24 hours after first intubation attempt, \[n\]
Incidence of bradycardia	first intubation attempt	Number of bradycardia (Hf \<100 bpm) during first intubation attempt
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, \[n\]

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zürich, Switzerland