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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group: New intubation method | Experimental | 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. |
|
| Control group: Conventional intubation | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New intubation method | Procedure |
| ||
| Conventional intubation method |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intubation attempts | Changes in the number of intubation attempts | During intubation process |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Malformation of the upper respiratory tract
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Morris, MD | Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz | Graz | 8036 | Austria |
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| Procedure |
|
| 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 |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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