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

NCT ID: NCT05162313

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2023-06-30

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).

Conditions

Tracheal Intubation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

confirmation of endotracheal tube positioning

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Minutes
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Paolo Biban

Director, Neonatal Intensive Care Unit, Dept. Neonatal and Pediatric Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Biban, MD

Role: CONTACT

PAOLO.BIBAN@AOVR.VENETO.IT

+00390458122041

Irene Sibona, MD

Role: CONTACT

irene.sibona@aovr.veneto.it

00390458121825

Facility Contacts

Paolo Biban, MD

Role: primary

paolo.biban@aovr.veneto.it

Other Identifiers

2880CESC

Identifier Type: -

Identifier Source: org_study_id