Clinical trial NCT05162313: Flow Sensor and Colourimetric Capnometer in Verifying Tracheal Tube Positioning in Term and Preterm Infants
Official title: Comparison Between Flow Sensor and Colourimetric Capnometer in Verifying the Correct Positioning of the Endotracheal Tube in Term and Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheal Intubation
Keywords: tracheal intubation
tracheal tube positioning
colorimetric capnometer
flow sensor
invasive mechanical ventilation
newborn
preterm infant
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Simultaneous assignment, as the two methods to confirm the endotracheal tube position, namely the colorimetric capnometer and the flow sensor signal, will be evaluated simultaneously in each recruited patient.
Primary purpose: DIAGNOSTIC

Brief summary: This is a multicentre clinical trial with medical device. As currently recommended by international neonatal resuscitation guidelines, the most reliable method to verify the correct positioning of the endotracheal tube, in association with clinical signs, is the end-tidal capnometry obtained either by infrared spectroscopy or colorimetric method. The aim of the present study is to evaluate whether the flow sensor of a standard mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube after a tracheal intubation attempt compared to the colorimetric capnometer, in newborns undergoing this procedure during hospitalization in the neonatal intensive care unit.

Given the importance of defining a rapid and effective method to prevent possible adverse events of incorrect endotracheal intubation, this study aims to verify whether the ventilator flow sensor can allow a reliable assessment of the correct positioning of the endotracheal tube, with timing and success rates equivalent to or better than the colorimetric capnometer.

Detailed description: Specifically, the neonatologist performing the procedure will follow the standard procedure for tracheal intubation, which includes using a colourimetric capnometer to confirm the correct tube positioning. However, he/she will remain blind and not aware of the flow sensor signal, while a study investigator will monitor that.

The investigators will measure the percentage of responses of correct positioning of the endotracheal tube as well as the number of insufflations and the time elapsed before obtaining a signal of correct intubation by simultaneously comparing both methods and checking any differences based on the characteristics of the sample analyzed (e.g. premature infants versus term infants, elective versus emergency intubations).

Eligibility criteria: Inclusion Criteria:

Term and preterm infants requiring tracheal intubation within the neonatal intensive care unit, both in elective and emergency conditions.

Exclusion Criteria:

* intubation at birth
* intubation during cardiopulmonary resuscitation
* absence of informed consent by parents

Primary outcomes:
measure: Time taken by the flow-sensor to indicate the correct or not correct positioning of the tracheal tube, compared with time taken by the colorimetric capnometer.
timeFrame: Immediately after the tracheal intubation attempt
measure: Number of mechanical breaths necessary to indicate the correct or not correct positioning of the tracheal tube by evaluating the flow-sensor curves and the color change of the colorimetric capnometer.
timeFrame: Immediately after the tracheal intubation attempt
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
Study officials:
References: