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Completed

NCT Number: NCT06139809

Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

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.

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Key information

Conditions

Infant, Newborn, Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intubation Complication

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intubation

Procedure

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.

Primary outcomes

  1. Successful nasal intubation at the first intubation attempt without physiological instability

    Time frame: 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 outcomes

  1. Incidence of desaturation

    Time frame: baseline to begin of first intubation attempt

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

  2. Incidence of bradycardia

    Time frame: baseline to begin of first intubation attempt

    Number of bradycardia (HR <100 bpm) between baseline and the begin of the first intubation attempt

  3. Peripheral oxygen saturation

    Time frame: baseline to begin of first intubation attempt

    Mean oxygen saturation over time between baseline and the begin of the first intubation attempt, SpO2 [%]

  4. Heart rate

    Time frame: baseline to begin of first intubation attempt

    Mean heart rate over time between baseline and the begin of the first intubation attempt, HR [bpm]

  5. Incidence of desaturation

    Time frame: first intubation attempt

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

  6. Incidence of bradycardia

    Time frame: first intubation attempt

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

  7. Peripheral oxygen saturation

    Time frame: first intubation attempt

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

  8. Heart rate

    Time frame: first intubation attempt

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

  9. Time to desaturation during first intubation attempt

    Time frame: 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.

  10. Duration of desaturation during first intubation attempt

    Time frame: first intubation attempt

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

  11. Time to bradycardia during first intubation attempt

    Time frame: first intubation attempt

    Time [sec] between time zero and bradycardia (HR <100 bpm) during the first intubation attempt.

  12. Duration of bradycardia during first intubation attempt

    Time frame: first intubation attempt

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

  13. Duration of intubation attempt(s)

    Time frame: overall intubation procedure

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

  14. Number of intubation attempts

    Time frame: overall intubation procedure

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

  15. Number of disconnections from ventilator circuit

    Time frame: overall intubation procedure

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

  16. Incidence of cardiac compressions

    Time frame: Within one hour of first intubation attempt

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

  17. Incidence of epinephrine administration

    Time frame: Within one hour of first intubation attempt

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

  18. Incidence of pneumothorax requiring drainage

    Time frame: Within 24 hours of first intubation attempt

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

  19. Incidence of death

    Time frame: Within 24 hours of first intubation attempt

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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: IntubAID

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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