Clinical trial NCT04680169: I-gel vs AuraGain for Bronchoscopic Intubation Through SGA
Official title: I-gel Versus AuraGain for Bronchoscopic Intubation Through Supraglottic Airway Device - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: Intubation
Bronchoscopic
Supraglottic airway device
I-gel
AuraGain
Flexible
Fiberoptic
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total time for airway management
timeFrame: Up to study completion, an average of 4 months
Secondary outcomes:
measure: Time to placement of SGA
timeFrame: Up to study completion, an average of 4 months
measure: Time to trans-device tracheal intubation
timeFrame: Up to study completion, an average of 4 months
measure: Number of attempts needed for correct placement of SGA
timeFrame: Up to study completion, an average of 4 months
measure: Number of attempts needed for correct intubation
timeFrame: Up to study completion, an average of 4 months
Other outcomes:
measure: Reason for failed intubation
timeFrame: Up to study completion, an average of 4 months
measure: Feeling of resistance during tracheal intubation
timeFrame: Up to study completion, an average of 4 months
measure: Feasibility of SGA placement
timeFrame: Up to study completion, an average of 4 months
measure: Feasibility of intubation
timeFrame: Up to study completion, an average of 4 months
measure: Feasibility of total airway management
timeFrame: Up to study completion, an average of 4 months
measure: Best Brimacombe score
timeFrame: Up to study completion, an average of 4 months
Locations:
city: Hillerød
country: Denmark
facility: Nordsjaellands Hospital
Study officials:
affiliation: Nordsjaellands Hospital
name: Charlotte V Rosenstock, Ph.d
role: PRINCIPAL_INVESTIGATOR
References: