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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz
Graz, Austria
Number of intubation attempts
Changes in the number of intubation attempts
Time frame: During intubation process
Duration of intubation process in minutes
Changes in duration
Time frame: 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.
Time frame: 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.
Time frame: During intubation process
Cerebral tissue oxygenation
Using near-infrared spectroscopy to monitor changes of the cerebral tissue oxygenation
Time frame: 5 minutes before intubation start till 10 minutes after successful intubation
Morbidity
Changes in morbidity
Time frame: up to 2 years
Mortality
Changes in mortality
Time frame: up to 2 years
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