NCT06767995

Comparison of Two Airway Devices in Paediatric Patients With Difficult Airway

Comparison of GlideScope® Titanium (Verathon) and Flexible Intubation Video Endoscope® (FIVE, Storz) In Terms Of Intubation Success In Infants With Pierre Robin Sequence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

Summary

The aim of current study was to compare Flexible fiberoptic bronchoscopy (FFB) and Glidescope devices in terms of intubation success and duration of intubation in patients under 12 months of age with PRS. In the present study, the investigators found similar initial intubation success rates with Glidescope and FFB. Although further studies are needed to determine the superiority of the two techniques, the investigators believes that advanced airway techniques should be prioritized and can be safely used by reducing the number of interventions.

Detailed description

Flexible fiberoptic bronchoscopy (FFB) is considered the gold standard for airway management in both adult and pediatric patients with known or anticipated difficult airways. New generation videolaryngoscopy systems have also been successfully used as an alternative to FFB in pediatric patients with anticipated difficult airways. Airway management in patients with Pierre Robin Sequence (PRS) is challenging due to the classic triad of glossoptosis, micrognathia, and airway obstruction, along with potential accompanying syndromes and anomalies. It is clear that advanced airway techniques should be used in this patient group. However, there are not many studies in the literature demonstrating the success or superiority of these advanced airway techniques. The aim of current study was to compare FFB and Glidescope devices in terms of intubation success and duration of intubation in patients under 12 months of age with PRS. The current study is a prospective randomized controlled trial. Following ethical approval, between March 2021 and December 2023, intubation success and duration were compared between Flexible Intubation Video Endoscope (FIVE)® or GlideScope® Titanium devices in PRS patients under 12 months of age who underwent elective surgery under general anesthesia. Patients' anthropometric data such as age, weight, height, gender, preoperative airway examination measurements including mouth opening (MO), thyromental distance (TMD), frontal plane-chin distance (FPCD), and FPCD/weight index were recorded. Patients were randomized and intubated by two experienced faculty members using either FFB or Glidescope. Intubation success on the first attempt, intubation duration, glottic visualization time, and complications were recorded by a non-blinded research assistant. Both devices were compared for these parameters. The current study included 50 PRS patients, with 23 in the FFB group and 27 in the Glidescope group. There were no statistically significant differences between the two patient groups in terms of age, gender, anthropometric measurements, mouth opening, TMD, FPCD, and FPCD/weight index. There was no statistically significant difference in intubation success on the first attempt between the two groups (81.5% for Glidescope and 87% for FFB, p=0.430). The median intubation duration was statistically significantly shorter in the Glidescope group (35 seconds, IQR=10.5) compared to the FFB group (40 seconds, IQR=18) (p=0.032). Since the endotracheal tube passage times were similar in both groups, this difference was attributed to the time to achieve optimal glottic visualization. The median time to achieve optimal glottic visualization was 9.5 seconds (IQR=7.5) in the Glidescope group and 16 seconds (IQR=14) in the FFB group (p=0.002). However, the clinical significance of this difference cannot be conclusively determined. Moreover, complication rates during the procedure were similar between the two groups (18.5% for Glidescope and 13% for FFB, p=0.711). There is currently no validated test for predicting difficult preoperative airways in PRS patients. Literature reviews suggest that pediatric reference values for MO, TMD, and FPCD measurements are controversial, and more studies are needed to establish appropriate reference values. In the present study, the investigators found similar initial intubation success rates with Glidescope and FFB. Although further studies are needed to determine the superiority of the two techniques, the investigators believes that advanced airway techniques should be prioritized and can be safely used by reducing the number of interventions.

Conditions

• Intubation; Difficult or Failed

Interventions

Type	Name	Description
DEVICE	Flexible fiberoptic bronchoscopy	If Flexible Intubation Video Endoscope® (FIVE) will be used, the appropriate endotracheal tube is loaded into the bronchoscope and made ready. The number of attempts and duration of successful intubation were recorded by a non-blinded research assistant. The stopwatch was started when the FFB started to pass through the patient's mouth/nose, and as soon as the ventilation of the lungs was confirmed by the end tidal carbon dioxide trace, the stopwatch was stopped and this time was recorded as the successful intubation time. The time between passing FFB through the mouth/nose and obtaining the best glottic view was recorded as the best glottic visualization time. The endotracheal tube passage time was defined as the intubation time minus the best glottic visualization time and recorded. Complications during the procedure were recorded.
DEVICE	Glidescope	If GlideScope® Titanium is to be used, a 50-60° angle is applied with the appropriate stylet, and the appropriate one from 3 pediatric blade sizes is selected according to the clinical experience of the relevant practitioner. The number of attempts and duration of successful intubation were recorded by a non-blinded research assistant. The stopwatch was started as soon as the videolaryngoscope started to pass through the patient's mouth, and the stopwatch was stopped as soon as the ventilation of the lungs was confirmed by the end tidal carbon dioxide trace, and this time was recorded as the successful intubation time. The time between passing the videolaryngoscope through the mouth/nose and obtaining the best glottic view was recorded as the best glottic visualization time. Endotracheal tube transit time was defined as intubation time minus best glottic visualization time and recorded. Complications during the procedure were recorded.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study