Clinical trial NCT06139809: Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation
Official title: The IntubAID Study - Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant, Newborn, Diseases
Intubation Complication
Keywords: Intubation
Non-invasive ventilation
Non-invasive positive pressure ventilation
Continuous positive airway pressure
Mechanical ventilation
Physiological stability
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective single-center study
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Successful nasal intubation at the first intubation attempt without physiological instability
timeFrame: first intubation attempt
Secondary outcomes:
measure: Incidence of desaturation
timeFrame: baseline to begin of first intubation attempt
measure: Incidence of bradycardia
timeFrame: baseline to begin of first intubation attempt
measure: Peripheral oxygen saturation
timeFrame: baseline to begin of first intubation attempt
measure: Heart rate
timeFrame: baseline to begin of first intubation attempt
measure: Incidence of desaturation
timeFrame: first intubation attempt
measure: Incidence of bradycardia
timeFrame: first intubation attempt
measure: Peripheral oxygen saturation
timeFrame: first intubation attempt
measure: Heart rate
timeFrame: first intubation attempt
measure: Time to desaturation during first intubation attempt
timeFrame: first intubation attempt
measure: Duration of desaturation during first intubation attempt
timeFrame: first intubation attempt
measure: Time to bradycardia during first intubation attempt
timeFrame: first intubation attempt
measure: Duration of bradycardia during first intubation attempt
timeFrame: first intubation attempt
measure: Duration of intubation attempt(s)
timeFrame: overall intubation procedure
measure: Number of intubation attempts
timeFrame: overall intubation procedure
measure: Number of disconnections from ventilator circuit
timeFrame: overall intubation procedure
measure: Incidence of cardiac compressions
timeFrame: Within one hour of first intubation attempt
measure: Incidence of epinephrine administration
timeFrame: Within one hour of first intubation attempt
measure: Incidence of pneumothorax requiring drainage
timeFrame: Within 24 hours of first intubation attempt
measure: Incidence of death
timeFrame: Within 24 hours of first intubation attempt
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Newborn Research, Depatrment of Neonatology, University Hospital and University of Zurich
name: Dirk Bassler, MD
role: STUDY_CHAIR
References:
citation: Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.
citation: Kothari R, Hodgson KA, Davis PG, Thio M, Manley BJ, O'Currain E. Time to desaturation in preterm infants undergoing endotracheal intubation. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):603-607. doi: 10.1136/archdischild-2020-319509. Epub 2021 Apr 30.
citation: Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.
citation: Kamlin CO, O'Connell LA, Morley CJ, Dawson JA, Donath SM, O'Donnell CP, Davis PG. A randomized trial of stylets for intubating newborn infants. Pediatrics. 2013 Jan;131(1):e198-205. doi: 10.1542/peds.2012-0802. Epub 2012 Dec 10.
citation: Lemyre B, Deguise MO, Benson P, Kirpalani H, Ekhaguere OA, Davis PG. Early nasal intermittent positive pressure ventilation (NIPPV) versus early nasal continuous positive airway pressure (NCPAP) for preterm infants. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD005384. doi: 10.1002/14651858.CD005384.pub3.