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

NCT05162313 | Unknown

• 1 other identifier: 2880CESC
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Tracheal Intubation

Keywords

tracheal intubation; tracheal tube positioning; colorimetric capnometer; flow sensor; invasive mechanical ventilation; newborn; preterm infant

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

all patients undergoing tracheal intubation procedure

OTHER

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

Interventions

confirmation of endotracheal tube positioning DEVICE

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.

all patients undergoing tracheal intubation procedure

Eligibility Criteria

• Age: 20 Minutes - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Paolo Biban, MD

CONTACT

+00390458122041; PAOLO.BIBAN@AOVR.VENETO.IT

Irene Sibona, MD

CONTACT

00390458121825; irene.sibona@aovr.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are newborns. The care provider will be the attending physician performing the tracheal intubation procedure as per local protocols, including the colourimetric capnometry analysis. However, he/she will remain blind and not aware of the flow sensor data until the end of the procedure.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Neonatal Intensive Care Unit, Dept. Neonatal and Pediatric Critical Care

Model Details: 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.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: February 10, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

IT (1)