MedTrace Logo

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

NCT05162313 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2022-03-08

No results posted yet for this study

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.

Conditions

  • Tracheal Intubation

Interventions

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.

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Minutes
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2023-04-30
Completion
2023-06-30

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162313 on ClinicalTrials.gov