Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

Intubation Complication Clinical Trial

— IntubAID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06139809
• Other study ID #: IntubAID
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: University of Zurich
• Contact: Christoph Rüegger, MD
• Phone: +41 43 253 98 10
• Email: christoph.rueegger[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Intubation Complication

Intervention

Procedure:
• Intubation
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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	first intubation attempt
Secondary	Incidence of desaturation	Number of desaturations (SpO2 <80 %) between baseline and the begin of the first intubation attempt	baseline to begin of first intubation attempt
Secondary	Incidence of bradycardia	Number of bradycardia (HR <100 bpm) between baseline and the begin of the first intubation attempt	baseline to begin of first intubation attempt
Secondary	Peripheral oxygen saturation	Mean oxygen saturation over time between baseline and the begin of the first intubation attempt, SpO2 [%]	baseline to begin of first intubation attempt
Secondary	Heart rate	Mean heart rate over time between baseline and the begin of the first intubation attempt, HR [bpm]	baseline to begin of first intubation attempt
Secondary	Incidence of desaturation	Number of desaturations (SpO2 <80 %) during first intubation attempt	first intubation attempt
Secondary	Incidence of bradycardia	Number of bradycardia (Hf <100 bpm) during first intubation attempt	first intubation attempt
Secondary	Peripheral oxygen saturation	Mean oxygen saturation over time during first intubation attempt, SpO2 [%]	first intubation attempt
Secondary	Heart rate	Mean heart rate over time during first intubation attempt, HR [bpm]	first intubation attempt
Secondary	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.	first intubation attempt
Secondary	Duration of desaturation during first intubation attempt	Time of SpO2 spent below 80% during the first intubation attempt	first intubation attempt
Secondary	Time to bradycardia during first intubation attempt	Time [sec] between time zero and bradycardia (HR <100 bpm) during the first intubation attempt.	first intubation attempt
Secondary	Duration of bradycardia during first intubation attempt	Time of HR spent below 100 bpm during the first intubation attempt	first intubation attempt
Secondary	Duration of intubation attempt(s)	Time from baseline to successful intubation including all intubation attempts, [sec]	overall intubation procedure
Secondary	Number of intubation attempts	Total number of intubation attempts to successful intubation, [n]	overall intubation procedure
Secondary	Number of disconnections from ventilator circuit	Total number of disconnections from ventilator circuit between baseline and end of intubation attempt(s), [n]	overall intubation procedure
Secondary	Incidence of cardiac compressions	Incidence of cardiac compressions within one hour after first intubation attempt, [n]	Within one hour of first intubation attempt
Secondary	Incidence of epinephrine administration	Incidence of epinephrine administration within one hour after first intubation attempt, [n]	Within one hour of first intubation attempt
Secondary	Incidence of pneumothorax requiring drainage	Incidence of pneumothorax requiring drainage within 24 hours after first intubation attempt, [n]	Within 24 hours of first intubation attempt
Secondary	Incidence of death	Incidence of death within 24 hours after first intubation attempt, [n]	Within 24 hours of first intubation attempt