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

Study Overview
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Brief Summary
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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

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

Conditions
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Intubation; Difficult or Failed, Preterm Infant, Term Infant

Intervention / Treatment
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* Procedure: New intubation method
* Procedure: Conventional intubation method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group: New intubation method<br>In the new intubation method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). Therefore an oxygen flow is already administered via the tube during the intubation process. | Procedure: New intubation method<br> <br> |
| Other: Control group: Conventional intubation<br>In the control group the respirator is connected to the tube and ventilation is started after the insertion of the tube into the trachea. Therefore there is no oxygen flow administered during the intubation process. | Procedure: Conventional intubation method<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intubation attempts | Changes in the number of intubation attempts | During intubation process | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of intubation process in minutes | Changes in duration | During intubation process | 
| Number of desaturations | 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. | During intubation process | 
| Total amount of time of desaturations | 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. | During intubation process | 
| Cerebral tissue oxygenation | Using near-infrared spectroscopy to monitor changes of the cerebral tissue oxygenation | 5 minutes before intubation start till 10 minutes after successful intubation | 
| Morbidity | Changes in morbidity | up to 2 years | 
| Mortality | Changes in mortality | up to 2 years |