NCT04089540

New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates

New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates. A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 1 Minute – 4 Months
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and control groups during intubation. Hypothesis * The new intubation method is safe * The new intubation method leads to a reduction in the number of intubation attempts * The new intubation method leads to a reduction of desaturations and bradycardia during intubation * In the long term, it could lead to a reduction in morbidity and mortality

Conditions

• Intubation; Difficult or Failed
• Preterm Infant
• Term Infant

Interventions

Type	Name	Description
PROCEDURE	New intubation method
PROCEDURE	Conventional intubation method

Timeline

• Start date: 2016-10-01
• Primary completion: 2021-01-01
• Completion: 2021-03-01
• First posted: 2019-09-13
• Last updated: 2021-03-16

Locations

1 site across 1 country: Austria