NCT05162313

Flow Sensor and Colourimetric Capnometer in Verifying Tracheal Tube Positioning in Term and Preterm Infants

Comparison Between Flow Sensor and Colourimetric Capnometer in Verifying the Correct Positioning of the Endotracheal Tube in Term and Preterm Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 20 Minutes – 3 Months
• Healthy volunteers: Not accepted

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).

Conditions

• Tracheal Intubation

Interventions

Type	Name	Description
DEVICE	confirmation of endotracheal tube positioning	After performing the tube insertion by direct laryngoscopy, videolaringoscopy or fiberoptic technique, the attending neonatologist will connect both the colorimetric capnometer and the proximal flow-sensor to the tracheal tube. If the flow sensor is not proximal but incorporated into the mechanical ventilator, the care provider will connect the capnometer only. During the procedure, the information given by the capnometer will be evaluated by the care provider performing the intubation, while the flow sensor information will be monitored only by a study investigator, who will not reveal any details to the care provider. In particular, the yellow color change by the capnometer and the presence of exhalation flow curves on the ventilator screen will be considered as confirmation of correct tracheal tube positioning, respectively.

Timeline

• Start date: 2022-02-10
• Primary completion: 2023-04-01
• Completion: 2023-06-01
• First posted: 2021-12-17
• Last updated: 2022-03-08

Locations

1 site across 1 country: Italy