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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheal Intubation
• Intervention / Treatment: Device: confirmation of endotracheal tube positioning

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).

• Study Type: Interventional
• Enrollment (Anticipated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Biban, MD; Phone Number: +00390458122041; Email: PAOLO.BIBAN@AOVR.VENETO.IT
• Study Contact Backup: Name: Irene Sibona, MD; Phone Number: 00390458121825; Email: irene.sibona@aovr.veneto.it

Study Locations

• Italy
  • Verona, Italy, 37126
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona
    • Contact: Paolo Biban, MD; Email: paolo.biban@aovr.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 minutes to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: all patients undergoing tracheal intubation procedure; In current practice, the endotracheal intubation procedure includes the systematic use of the capnometer, which is immediately connected to the tube after its insertion by direct laringoscopy. Confirmation of the correct tube positioning is established by color change of the capnometer from violet to yellow. Then, the colorimetric capnometer is usually removed before connecting the endotracheal tube to the flow-sensor of the ventilator. For the purpose of our study, after the tube insertion the care provider will connect in line both the capnometer and the ventilator flow-sensor to the tracheal tube.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	To compare the time (expressed in seconds) taken by the flow sensor and the colorimetric capnometer, respectively, to indicate the correct or not correct positioning of the tube in newborns undergoing tracheal intubation procedure during neonatal intensive care unit admission. The aim is to evaluate if the flow sensor of the mechanical ventilator can discriminate with similar or faster times the correct positioning of the tube during the tracheal intubation procedure compared to the colorimetric capnometer.	Immediately after the tracheal intubation attempt
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.	To compare the minimal number of mechanical breaths provided by the ventilator to indicate the correct or not correct positioning of the tube in newborns undergoing tracheal intubation procedure, either evaluating the flow-sensor curves and the color change of the colorimetric capnometer, respectively. The aim is to evaluate if the flow sensor of the mechanical ventilator can indicate with lower or equal number of mechanical breaths the correct positioning of the tube during tracheal intubation compared to the colorimetric capnometer.	Immediately after the tracheal intubation attempt

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: newborn; invasive mechanical ventilation; preterm infant; tracheal intubation; flow sensor; tracheal tube positioning; colorimetric capnometer
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2880CESC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No