Intubation Complication Clinical Trial
— IntubAIDOfficial title:
The IntubAID Study - 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.
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
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
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 |
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