Clinical Trials Logo
  1. Home
  2. Tracheal Intubation
  3. NCT05162313

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

Tracheal Intubation Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05162313
Study type Interventional
Source Azienda Ospedaliera Universitaria Integrata Verona
Contact Paolo Biban, MD
Phone +00390458122041
Email PAOLO.BIBAN@AOVR.VENETO.IT
Status Recruiting
Phase N/A
Start date February 10, 2022
Completion date June 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT02245789 - Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ? N/A
Terminated NCT02040961 - Assessment of the the ETView Double-lumen Tube N/A
Completed NCT01210105 - Ice-pick Intubation With Video Laryngoscopes in a Manikin With Restricted Access to the Airway N/A
Not yet recruiting NCT05482230 - Application of Tracheal Intubation in Lateral Position in Thoracic Surgery N/A
Completed NCT02590237 - KingVision Video Laryngoscopy vs Direct Laryngoscopy - Equivalence Trial N/A
Completed NCT01100957 - Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation N/A
Completed NCT04091568 - Patient Experience Following Awake Fibreoptic Intubation Compared to Asleep Fibreoptic Intubation
Not yet recruiting NCT04099069 - The Impacts of the Different Anesthesia Methods on Patients of Transbronchial Cryobiopsy N/A
Completed NCT05160207 - Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia
Terminated NCT02292901 - McGrath Mac VideoLaryngoscope vs the Macintosh Laryngoscope N/A
Completed NCT02029300 - A Comparison of Nasal Versus Oral Fiberoptic Intubation in Children N/A
Recruiting NCT04909476 - Tracheal Intubation in COVID-19 Patients
Completed NCT03693235 - Adequate Bending Angle of a Lightwand N/A
Completed NCT03874403 - Anesthetic Component Research on VATS and NIVATS N/A
Completed NCT00908817 - Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat N/A
Not yet recruiting NCT06331611 - MONITORING NEUROMUSCULAR BLOCK IN PAEDIATRIC ANAESTHESIA N/A
Completed NCT03930550 - Infrared Transillumination of the Front of the Neck N/A
Completed NCT02074098 - Endotracheal Intubation Using Macintosh Laryngoscope, Glidescope, Airwayscope During Chest Compression With Adjustment Height of a Bed N/A
Completed NCT01516164 - A Comparison of the Ease of Tracheal Intubation Using a McGrath MAC Laryngoscope and a Standard MacIntosh Laryngoscope N/A
Completed NCT03045094 - Neck Movement Implicate the Tracheal Tube-tip Displacement in Pediatric Surgery