I-gel vs AuraGain for Bronchoscopic Intubation Through SGA

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680169
• Other study ID #: Intubation through SGA
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: May 4, 2021

Study information

• Verified date: December 2020
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• Bronchoscopic intubation through AuraGain LMA
Comparing two different SGAs as conduit for bronchoscopic tracheal intubation
• Bronchoscopic intubation through I-gel SGA
Comparing two different SGAs as conduit for bronchoscopic tracheal intubation

Locations

Country	Name	City	State
Denmark	Nordsjaellands Hospital	Hillerød

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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