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Completed

NCT Number: NCT04680169

I-gel vs AuraGain for Bronchoscopic Intubation Through SGA

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.

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Key information

Conditions

Airway Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nordsjaellands Hospital

Hillerød, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopic intubation through AuraGain LMA

Device

Comparing two different SGAs as conduit for bronchoscopic tracheal intubation

Bronchoscopic intubation through I-gel SGA

Device

Comparing two different SGAs as conduit for bronchoscopic tracheal intubation

Primary outcomes

  1. Total time for airway management

    Time frame: Up to study completion, an average of 4 months

    Total time from reaching the SGA with hands to ended bronchoscopic tracheal intubation confirmed by the end of first curve on capnography

Secondary outcomes

  1. Time to placement of SGA

    Time frame: Up to study completion, an average of 4 months

    Time measured from reaching SGA with hands to correct placement of SGA confirmed by end of first curve on capnography

  2. Time to trans-device tracheal intubation

    Time frame: Up to study completion, an average of 4 months

    time measured from confirmed placement of SGA until successful tracheal intubation confirmed by end of first curve on capnography

  3. Number of attempts needed for correct placement of SGA

    Time frame: Up to study completion, an average of 4 months

    two attempts at correct placement allowed. Attempt is failed if no curve appears on capnography.

  4. Number of attempts needed for correct intubation

    Time frame: Up to study completion, an average of 4 months

    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.

Other outcomes

  1. Reason for failed intubation

    Time frame: Up to study completion, an average of 4 months

    if failed (as described in outcome 4), reason of failure is described

  2. Feeling of resistance during tracheal intubation

    Time frame: Up to study completion, an average of 4 months

    Physician will be asked to report resistance as: none, mild, severe, impossible

  3. Feasibility of SGA placement

    Time frame: Up to study completion, an average of 4 months

    Physician will be asked to report feasibility at a scale 1-10, 1=easy, 10=very difficult

  4. Feasibility of intubation

    Time frame: Up to study completion, an average of 4 months

    Physician will be asked to report feasibility at a scale 1-10, 1=easy, 10=very difficult

  5. Feasibility of total airway management

    Time frame: Up to study completion, an average of 4 months

    Physician will be asked to report feasibility of the whole procedure at a scale 1-10, 1=easy, 10=very difficult

  6. Best Brimacombe score

    Time frame: Up to study completion, an average of 4 months

    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.

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2020
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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