I-gel vs AuraGain for Bronchoscopic Intubation Through SGA

Nordsjaellands Hospital

Status

Completed

Conditions

Airway Management

Treatments

Device: Bronchoscopic intubation through I-gel SGA

Device: Bronchoscopic intubation through AuraGain LMA

Study type

Interventional

Funder types

Other

Identifiers

NCT04680169

Intubation through SGA

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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