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Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation (IntubAID)

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Intubation Complication
Infant, Newborn, Diseases

Treatments

Procedure: Intubation

Study type

Interventional

Funder types

Other

Identifiers

NCT06139809
IntubAID

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Intubation
Other group
Description:
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 \[bpm\]).
Treatment:
Procedure: Intubation

Trial contacts and locations

1

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Central trial contact

Christoph Rüegger, MD

Data sourced from clinicaltrials.gov

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