Intubation; Difficult or Failed, Preterm Infant, Term Infant
Conditions
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
Interventions
PROCEDURENew intubation method
PROCEDUREConventional intubation method
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 4 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubation attempts | During intubation process | Changes in the number of intubation attempts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Duration of intubation process in minutes | During intubation process | Changes in duration |
| Morbidity | up to 2 years | Changes in morbidity |
| Mortality | up to 2 years | Changes in mortality |
| 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 |
Countries
Austria
Outcome results
None listed