Clinical trial NCT06767995: Comparison of Two Airway Devices in Paediatric Patients With Difficult Airway
Official title: Comparison of GlideScope® Titanium (Verathon) and Flexible Intubation Video Endoscope® (FIVE, Storz) In Terms Of Intubation Success In Infants With Pierre Robin Sequence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Keywords: fiberoptic bronchoscope
videolaryngoscopy
difficult airway
Pierre Robin Sequence
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Our study is a prospective randomized controlled study. Intubation success and intubation times were compared with Flexible Intubation Video Endoscope (FIVE)® or GlideScope® Titanium devices in patients with Pierre Robin Sequence. Randomization was performed by a research assistant who used a computer to generate random numbers 1 and 2 and was terminated when the minimum number of patients in both groups was reached. The number 1 is assigned to the GlideScope® Titanium and the number 2 is assigned to the Flexible Intubation Video Endoscope® (FIVE). Randomization was concealed from the practitioner in a sealed envelope and informed to the practitioner after parental consent to participate in the study was obtained.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intubation success on the first attempt
timeFrame: 34 months
Secondary outcomes:
measure: Time to intubation
timeFrame: 34 months
measure: Glottic visualization time
timeFrame: 34 months
measure: Complications
timeFrame: 34 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine
state: Sihhiye
Study officials:
References: