I-gel vs AuraGain for Bronchoscopic Intubation Through SGA

I-gel Versus AuraGain for Bronchoscopic Intubation Through Supraglottic Airway Device - a Randomized Controlled Trial

This trial compares two different second generation supraglottic airway devices (AuraGain and I-gel) used as a conduit for bronchoscopic tracheal intubation during continuous oxygenation in order tο determine time to successful tracheal intubation and ease of use.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: Bronchoscopic intubation through AuraGain LMA; Device: Bronchoscopic intubation through I-gel SGA

Detailed Description

A prospective randomized controlled trial in the Department of Anesthesiology, Copenhagen University Hospital Nordsjællands Hospital-Hillerød Denmark. The study is approved by the Ethics Committee, capital region of Denmark. The aim of the study is to compare bronchoscopic tracheal intubation during continuous oxygenation through the AuraGain and I-gel supraglottic airway device. One hundred patients will be randomly allocated into two groups, group A (AuraGain) and group B (I-gel). Study outcomes are time to tracheal intubation confirmed by capnography as well as anesthesiologists reports of ease of use. Twenty-five anesthesiologists participates in this study, and are allocated four patient each. In random order, each physician will perform two bronchoscopic tracheal intubations with each SGA.

In the preoperative setting, a complete anesthetic evaluation will be performed, including a detailed airway assessment determining predictors for difficulties of face mask ventilation, insertion of SGA and tracheal intubation. Participants are scheduled to undergo elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with 100% oxygen. After induction, rocuronium 0.6mg/kg will be used to facilitate neuromuscular blockade. Sufficient face mask ventilation will be performed before intervention.

Group A: AuraGain:

Time is measured from when the anesthesiologist reaches for the AuraGain LMA until the mask is placed and adequate ventilation is confirmed by capnography. The AuraGain LMA will be used as conduit for bronchoscopic intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.

Group B: I-gel:

Time is measured from when the anesthesiologist reaches for the I-gel LMA until the mask is placed and adequate ventilation is confirmed by capnography.The I-gel LMA will be used as conduit for bronchoscopic tracheal intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.

In both groups (A and B) up to two attempts of SGA placement and up to three attempts of tracheal intubation are allowed.

In case of an emerging unpredicted difficult airway and a concurrent unsuccessful SGA placement, the difficult airway algorithm, DAS, UK will be followed. Video- assisted laryngoscopy will be the first option.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Nordsjaellands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for a non-acute ENT, gynaecological, gastrointestinal or orthopaedic surgical procedure for which general anaesthesia including oral intubation with an endotracheal tube will be provided

Exclusion Criteria:

• Age<18 years
• Inter-incisional distance <30mm
• Pregnant and BMI>40kg/m2
• ASA physical status classification system grade >3
• Earlier laryngeal or pharyngeal surgery
• Increased risk of aspiration (e.g. nasogastric tube inserted, planned Rapid Sequence Induction)
• Informed consent cannot be obtained
• Patients with stridor
• Patients with hypoxemia defines by saturation <90 without oxygen at arrival to the operating room
• Use of oxygen supply at home
• Need of one of the following special endotracheal tubes for scheduled surgery: neural integrity monitor (NIM) electromyogram (EMG) tracheal tubes, wire tubes
• Patients scheduled for any awake approach to secure the airway e.g. awake videolaryngoscopy, awake fiberoptic bronchoscope intubation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Group A: Bronchoscopic intubation using AuraGain LMA as conduit; A group of 50 patients randomly allocated to bronchoscopic intubation using AuraGain	Device: Bronchoscopic intubation through AuraGain LMA; Comparing two different SGAs as conduit for bronchoscopic tracheal intubation
ACTIVE_COMPARATOR: Group B: Bronchoscopic intubation with I-gel SGA as conduit; A group of 50 patients randomly allocated to bronchoscopic intubation using I-gel	Device: Bronchoscopic intubation through I-gel SGA; Comparing two different SGAs as conduit for bronchoscopic tracheal intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time for airway management	Total time from reaching the SGA with hands to ended bronchoscopic tracheal intubation confirmed by the end of first curve on capnography	Up to study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to placement of SGA	Time measured from reaching SGA with hands to correct placement of SGA confirmed by end of first curve on capnography	Up to study completion, an average of 4 months
Time to trans-device tracheal intubation	time measured from confirmed placement of SGA until successful tracheal intubation confirmed by end of first curve on capnography	Up to study completion, an average of 4 months
Number of attempts needed for correct placement of SGA	two attempts at correct placement allowed. Attempt is failed if no curve appears on capnography.	Up to study completion, an average of 4 months
Number of attempts needed for correct intubation	Attempt of bronchoscopic intubation begins when entering aScope in swivel. Attempt is failed if airway is not visualised, if tracheal tube can not be advanced in trachea, if SpO2 is <85% or if total time exceeds 6 minutes. Three attempts of intubation is allowed.	Up to study completion, an average of 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reason for failed intubation	if failed (as described in outcome 4), reason of failure is described	Up to study completion, an average of 4 months
Feeling of resistance during tracheal intubation	Physician will be asked to report resistance as: none, mild, severe, impossible	Up to study completion, an average of 4 months
Feasibility of SGA placement	Physician will be asked to report feasibility at a scale 1-10, 1=easy, 10=very difficult	Up to study completion, an average of 4 months
Feasibility of intubation	Physician will be asked to report feasibility at a scale 1-10, 1=easy, 10=very difficult	Up to study completion, an average of 4 months
Feasibility of total airway management	Physician will be asked to report feasibility of the whole procedure at a scale 1-10, 1=easy, 10=very difficult	Up to study completion, an average of 4 months
Best Brimacombe score	Class 1: Unable to see the vocal cords. Class 2: the vocal cords and the anterior aspect of the epiglottis are visualized. Class 3: the vocal cords and the posterior aspect of the epiglottis are observed. Grade 4: only vocal cords were observed.	Up to study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Charlotte V Rosenstock, Ph.d, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2021
• Primary Completion (ACTUAL): May 4, 2021
• Study Completion (ACTUAL): May 4, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Fiberoptic; Intubation; Supraglottic airway device; I-gel; Flexible; Bronchoscopic; AuraGain
• Other Study ID Numbers: Intubation through SGA

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: No