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

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.

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed
• Intervention / Treatment: Device: Flexible fiberoptic bronchoscopy; Device: Glidescope

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sihhiye
    • Ankara, Sihhiye, Turkey, 06230
      • Hacettepe University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being under 12 months,
• Being diagnosed with Pierre Robin Sequence,
• Being subjected to elective surgery,
• To be operated between 01 March 2021 and 31 December 2023.

Exclusion Criteria:

• Patients requiring emergency surgery, patients requiring rapid serial intubation,
• Patients who have already been taken to the operating room by intubation or tracheostomy,
• Patients who will not be processed under general anesthesia,
• Patients who do not have family consent and informed consent cannot be obtained

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intubation with Flexible fiberoptic bronchoscopy; Patients were intubated with FFB and intubation success, intubation time, glottic visualization time and complications were recorded. FFB is considered the gold standard for airway management in both adult and pediatric patients with known or anticipated difficult airways.	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.; Other Names: Flexible Intubation Video Endoscope (FIVE)®
Active Comparator: Intubation with Glidescope; Patients were intubated with Glidescope and intubation success, intubation time, glottic visualization time and complications were recorded. New generation videolaryngoscopy systems have also been successfully used as an alternative to FFB in pediatric patients with anticipated difficult airways. One of the most frequently used is Glidescope.	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.; Other Names: GlideScope® Titanium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation success on the first attempt	It was defined as a successful intubation attempt on the first attempt using FFB or Glidescope. Successful intubation was confirmed by end tidal carbon dioxide tracing. Failed intubation was defined as an intubation attempt lasting more than 120 seconds, removal and repositioning of the airway device from the mouth/nose, or esophageal intubation.	34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubation	It is defined as the time between the FFB passing through the patient's mouth/nose or the videolaryngoscope passing through the patient's mouth and the end tidal carbon dioxide trace appearing on the monitor.	34 months
Glottic visualization time	It is defined as the time between the passage of the FFB through the patient's mouth/nose or the passage of the videolaryngoscope through the patient's mouth and the acquisition of the best glottic view.	34 months
Complications	Complications; esophageal intubation, desaturation defined as SpO2<90%, airway bleeding, soft tissue damage, bradycardia (heart rate below 90 beats/min), systolic hypotension (below 60mmHg for 0-1 months, below 70mmHg for 1-12 months), dysrhythmia was determined as cardiac arrest.	34 months

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: difficult airway; videolaryngoscopy; fiberoptic bronchoscope; Pierre Robin Sequence
• Other Study ID Numbers: HacettepeÜ-AR-BE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes