Blind Versus Fiberoptic Intubation Through I-GEL
Condition: I-gel
Study type: Interventional

Summary: 
      Aim of the work

      To compare between use of I-gel as a conduit for blind intubation and as a conduit for
      fiberoptic guided intubation in children and also aim to validate the use of I-gel as conduit
      for blind intubation in absence of fiberoptic or lack of experience of its use.

      Objectives:

        -  To validate I-gel use as blind intubating conduit in children.

        -  To Estimate the duration of blind intubation using I-gel and duration of fiberoptic
           guided intubation through I-gel.

      Ethical Considerations

      The study protocol will be approved by the Research Ethics Committee.
    

Detailed description: 
      Introduction:

      A supraglottic airway device is designed to maintain a clear airway while sitting above, and
      creating a seal around the larynx. It may be used in elective surgery, as an airway rescue
      device in failed tracheal intubation, as a conduit for tracheal intubation, or in emergencies
      such as cardiorespiratory arrest, both in and out of hospital.

      'First-generation'supraglottic airway devices are simple airway tubes such as the laryngeal
      mask airway (LMA) Classic. 'Second generation' devices contain suction ports and integral
      bite blocks, these include the LMA Proseal and the i-gel.

      The I-gel is the innovate second generation supraglottic airway and it is considered the
      first major development since LMA. The I-gel has changed the face of airway management and is
      now widely used in anesthesia and resuscitation across the globe. It is made from a medical
      grade thermoplastic elastomer and it is designed to create a non-inflatable, anatomical seal
      of the pharyngeal, laryngeal and perilaryngeal structures.

      Pediatrics are not small adults, there are a number of anatomical differences which make
      airway management difficult than adults. Predicatably, these differences are most pronounced
      at birth and the most unfamiliar(non-adult like) airway is encountered in neonates and
      infants under 1 year of age.

      Aim of the work

      To compare between use of I-gel as a conduit for blind intubation and as a conduit for
      fiberoptic guided intubation in children and also aim to validate the use of I-gel as conduit
      for blind intubation in absence of fiberoptic or lack of experience of its use.

      Objectives:

        -  To validate I-gel use as blind intubating conduit in children.

        -  To Estimate the duration of blind intubation using I-gel and duration of fiberoptic
           guided intubation through I-gel.

      Ethical Considerations

      The study protocol will be approved by the Research Ethics Committee.

      Methodology

      I. Study design

      Prospective randomized controlled trial (non inferiority design)

      II. Study setting and location

      The study will be conducted in Children Hospital of Cairo University.

      III. Study population

      This Study will be conducted on 88 children aged from one to ten years presented for elective
      surgical procedure at Children Hospital of Cairo University. Patient will be divided into two
      equal groups; group C control group (n=44) and group B (blind) (n=44).

      V. Study Procedures

        1. Randomization (in RCT only) Once enrolled in the study, patients will be randomly
           assigned into two groups; fiberoptic guided (control) group (Group C: n= 44), blind
           group (Group B: n=44). Randomization will be done using computer generated number and
           concealed using sequentially numbered, sealed opaque envelope.

        2. Study Protocol Randomization will be done by computer generated numbers and concealed by
           serially numbered, opague and sealed envelopes. The details of the series will be
           unknown to the investigators and the group assignment will be kept in asset of sealed
           envelopes each bearing only the case number on the outside. Prior to surgery the
           appropriate numbered envelopes will be opened by the nurse, the card inside will
           determine the patient group.

           All children will be premedicated with oral midazolam 0.5mg/kg Half hour before
           procedure and atropine at a dose of 0.02mg/kg (IM). Continuous electrocardiogram (ECG),
           pulse oximetry, non-invasive arterial blood pressure, and temperature monitoring will be
           applied and all patients will be induced with inhalational anesthetic using Sevoflurane
           + oxygen (O2) and I.V line will be inserted. After deepening of the anesthesia, fentanyl
           1μg/kg, and muscle relaxant will be given in the form of atracurium 0.5mg/kg.

           The absence of mydriasis, divergent gaze, haemodynamic or motor response to the jaw
           thrust manoeuvre will be used as parameters to guide adequate depth of anesthesia(7).
           Supraglottic I-gel of appropriate size (according to body wight) will be inserted after
           lubrication with K-Y Lubricating Jelly (Johnson & Johnson Medical Limited, Gargrave,
           Skipton, UK). Air way manoeuvres like jaw thrust or head tilt will be used to facilitate
           insertion.

           Adequate ventilation will be confirmed by adequate chest expansion and capnography
           waveform. If ventilation is adequate, the SG I-gel will be secured. In case of
           inadequate ventilation after I-gel insertion, airway manoeuvres like adjusting head/neck
           position and changing depth of insertion can be used to improve ventilation.A maximum of
           three SGA insertion attempts will be allowed then conventional laryngoscopic intubation
           will be performed.

           After securing SG I-gel, according to patients group; in group C (control), a paediatric
           fibrescope will be primed with an appropriate size tracheal tube. The fibrescope will be
           introduced through I-gel and guide tracheal intubation. After insertion of tube and
           confirmation of position, the fiberscope will be removed

           In group B (blind); an appropriate size endotracheal tube will be introduced through
           I-gel blindly. Only smooth intubation without force together with manoeuvres necessary
           to correct the position of tracheal tube will be allowed. Only one attempt of blind
           intubation is allowed to avoid airway injury. Any resistance to first attempt tube
           insertion will indicate failure of blind tube insertion.

           In both groups, a second person will stabilise the SG I-gel in the set position in order
           to prevent unintentional movement during the intubation procedure and removal of I-gel.
           Tube insertion will be confirmed by capnography, fibrescope and bilateral air entry by
           auscultation after connection of breathing circuit. To remove the SG I-gel after
           successful intubation, the breathing circuit will be disconnected, and the I-gel will be
           withdrawn with the aid of a stylet (stabilizer) in a continuous push-pull movement. If
           saturation fall below 92%, or if facemask ventilation or ventilation via the SGA begin
           to fail, this indicate securing airway with conventional intubation

        3. Measurement tools

             -  Patients demographic data will be collected; age, gender, weight, height and type
                of surgery.

             -  The success rate and number of attempts of SG I-gel insertion will be recorded and
                the time taken for insertion from removal of face mask until appearance of
                end-tidal CO2 on the monitor after connection of the breathing circuit to the SG
                I-gel.

             -  The success rate of first attempt intubation and time taken for tube insertion from
                start of tube introduction till appearance of appearance of end-tidal CO2 on the
                monitor after connection of the breathing circuit to the tube will be recorded.

             -  Adverse events will be recorded ; suspicion of aspiration or regurgitation,
                hypoxia, bronchospasm, laryngospasm and coughing. Staining of blood on the SG I-gel
                will be recorded, as well as dental, tongue or lip trauma.

             -  Postoperative dysphagia, sore throat and hoarseness of voice will be recorded.

      VI. Study outcomes

        1. Primary outcome

             -  The success rate of first attempt intubation

        2. Secondary outcome(s)

             -  The success rate of SG I-gel insertion

             -  Number of trials of I-gel insertion with maximum three trials.

             -  Time taken for I-gel insertion.

             -  Time taken for endotracheal tube insertion.
    

Intervention name(s): I-gel
Intervention type(s): Device
Intervention description(s): To compare between use of I-gel as a conduit for blind intubation and as a conduit for fiberoptic guided intubation in children. We also aim to validate the use of I-gel as conduit for blind intubation in absence of fiberoptic or lack of experience of its use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other