Nasal Intermittent Positive Pressure Ventilation During Neonatal Intubation
NCT Number: NCT06549283
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Respiratory Distress Syndrome|Intubation; Difficult or Failed|Newborn Morbidity|Desaturation of Blood|Ventilator Lung; Newborn
Interventions: DEVICE: Nasal intermittent positive pressure ventilation (NIPPV) via binasal cannula during neonatal intubation
Sponsor: Muğla Sıtkı Koçman University
Sex: ALL
Age: CHILD
Enrollment: 146
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-07-15
Locations: Mugla Training and Research Hospital, Department of Neonatology, Mentese, Mugla, 48000, Turkey|Akdeniz University School of Medicine, Department of Neonatology, Antalya, 07000, Turkey

Summary:
The study aims to determine whether the use of nasal intermittent positive pressure ventilation (NIPPV) during neonatal endotracheal intubation increases the rate of successful intubation without physiological instability during all intubation attempts.

The present study was designed as a prospective, multicenter, randomized, controlled study conducted with neonates undergoing endotracheal intubation. The infants were assigned randomly to either the NIPPV group or the standard care group.

Primary Outcome Measures: Successful intubation without physiological instability during all intubation attempts, Successful intubation was defined as the placement of an endotracheal tube in the trachea, confirmed based on chest elevation, auscultation, second independent laryngoscopy, carbon dioxide detection, and/or chest radiography.

Physiological instability was defined as severe desaturation (a decrease of \>20% in oxygen saturation relative to that immediately prior to pre-laryngoscopy) or bradycardia (a heart rate of \<100 beats per minute) during the intubation attempts.

All intubation attempts was defined as the requirement for single, two, or multiple attempts for successful intubation., One year
Secondary Outcome Measures: Lowest SpO2 level, Lowest peripheral oxygen saturation level during intubation, One year|Lowest heart rate, Lowest heart rate during intubation, One year|Bradycardia, Bradycardia was defined as a heart rate of \<100 beats per minute, One year|Severe desaturation, Severe desaturation was defined as a decrease of ≥20% in oxygen saturation relative to the highest level of oxygen saturation recorded prior to the first attempt, One year|Successful intubation on the first attempt without physiological instability, Successful intubation was defined as the placement of an endotracheal tube in the trachea, confirmed based on chest elevation, auscultation, second independent laryngoscopy, carbon dioxide detection, and/or chest radiography.

Physiological instability was defined as severe desaturation (a decrease of \>20% in oxygen saturation relative to that immediately prior to pre-laryngoscopy) or bradycardia (a heart rate of \<100 beats per minute) during the intubation attempts., One year|Time to successful intubation, Time until successful intubation is achieved. Successful intubation was defined as the placement of an endotracheal tube in the trachea, confirmed based on chest elevation, auscultation, second independent laryngoscopy, carbon dioxide detection, and/or chest radiography., One year|Duration of severe desaturation, Duration of severe desaturation during intubation attempts. Severe desaturation was defined as a decrease of ≥20% in oxygen saturation relative to the highest level of oxygen saturation recorded prior to the first attempt, One year