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

Not Applicable

Completed

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

• Registration Number: NCT04089540
• Lead Sponsor: Medical University of Graz

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Primary Completion: 2021-01
• Status Verified: 2021-03
• Study Completion: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
• Fulfillment of indication for intubation

Exclusion Criteria

• Malformation of the upper respiratory tract

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of intubation attempts	During intubation process	Changes in the number of intubation attempts

Secondary Outcome Measures

Name	Time	Method
Duration of intubation process in minutes	During intubation process	Changes in duration
Number of desaturations	During intubation process	The number of desaturations below 80% SpO2; The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.
Total amount of time of desaturations	During intubation process	The total amount of time in seconds a patient spends below 80% SpO2.; The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.
Cerebral tissue oxygenation	5 minutes before intubation start till 10 minutes after successful intubation	Using near-infrared spectroscopy to monitor changes of the cerebral tissue oxygenation
Morbidity	up to 2 years	Changes in morbidity
Mortality	up to 2 years	Changes in mortality

Trial Locations

Locations (1)

Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz; 🇦🇹 Graz, Austria