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

Medical University of Graz

Status: Completed

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

Treatments: Procedure: New intubation method; Procedure: Conventional intubation method

Study type: Interventional

Funder types: Other

Identifiers

NCT04089540

NOONA

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 1 minute to 4 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Study group: New intubation method

Experimental group

Description:

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.

Treatment:

Procedure: New intubation method

Control group: Conventional intubation

Other group

Description:

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.

Treatment:

Procedure: Conventional intubation method