Comparison of Two Airway Devices in Paediatric Patients With Difficult Airway

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed

• Registration Number: NCT06767995
• Lead Sponsor: Hacettepe University

Brief 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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted: 2024-06-10
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Intubation success on the first attempt	34 months	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.

Secondary Outcome Measures

Name	Time	Method
Glottic visualization time	34 months	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.
Complications	34 months	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.
Time to intubation	34 months	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.

Trial Locations

Locations (1)

Hacettepe University Faculty of Medicine; 🇹🇷 Ankara, Sihhiye, Turkey