Comparison of Two Airway Devices in Paediatric Patients With Difficult Airway

NCT06767995 | Completed FDA Device

• 1 other identifier: HacettepeÜ-AR-BE-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult or Failed

Keywords

fiberoptic bronchoscope; videolaryngoscopy; difficult airway; Pierre Robin Sequence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to intubation

  34 months

• Glottic visualization time

  34 months

• Complications

  34 months

Study Arms (2)

Intubation with Flexible fiberoptic bronchoscopy

ACTIVE COMPARATOR

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

Intubation with Glidescope

ACTIVE COMPARATOR

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

Interventions

Flexible fiberoptic bronchoscopy DEVICE

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.

Also known as: Flexible Intubation Video Endoscope (FIVE)®

Intubation with Flexible fiberoptic bronchoscopy

Glidescope DEVICE

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.

Also known as: GlideScope® Titanium

Intubation with Glidescope

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Medicine

Ankara, Sihhiye, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pierre Robin Syndrome

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Specialist

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: January 10, 2025
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)