An interventional study of Bronchoscopic intubation through AuraGain LMA and Bronchoscopic intubation through I-gel SGA in Airway Management, sponsored by Nordsjaellands Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-21.
Sponsored by Nordsjaellands Hospital · Not applicable, Interventional, and Treatment
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.
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.
Nordsjaellands Hospital is the lead sponsor of 88 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A group of 50 patients randomly allocated to bronchoscopic intubation using AuraGain
Device: Bronchoscopic intubation through AuraGain LMA
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
Comparing two different SGAs as conduit for bronchoscopic tracheal intubation
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
Time frame: Up to study completion, an average of 4 months
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to study completion, an average of 4 months
Reason for failed intubation
if failed (as described in outcome 4), reason of failure is described
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to study completion, an average of 4 months
Plan to share: No
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Nordsjaellands Hospital