A Comparative Study Between Laryseal Pro Supra Glottic Device (SGD) With Proseal Laryngeal Mask Airway
Condition: Ophthalmic Surgery
Study type: Interventional

Summary: 
      Difficult airway is a nightmare to every anesthetist. Over the last decade, several
      supraglottic airway devices appeared in the clinical field as an alternative to the more
      invasive endotracheal intubation(1). However, many anesthetists found themselves unaccustomed
      with the newly invented devices .Supraglottic airway devices (SAD) have become valuable for
      both routine and difficult airway management. After the creation of the laryngeal mask airway
      (LMA) classic in the 1980s, there has been a steady increase in the applications for use of
      supraglottic airways. Developed by Dr. Archie Brain in 2000, the ProSeal laryngeal mask
      airway (P-LMA) is a second-generation supraglottic airway device (SAD) with two lumens
      separating the alimentary and respiratory channels from each other This study aim to compare
      the use of the Laryseal Pro and the Proseal LMA as a supraglottic devices by measuring the
      time of insertion (which is defined as time interval in seconds between removing the
      ventilation mask and picking the device up till connecting to the ventilator and appearance
      of the ﬁrst wave on the capnogram)

      Objectives:

      To determine ease of insertion for each supra glotic device. To Estimate the time needed for
      insertion for each supra glotic device. To identify airway pressure leakage, gastric tube
      insertion success and complication for each device.

      It is hypothesized that the Laryseal pro is a safe superior supraglottic airway device and
      its insertion is easier than the LMA-Proseal .
    

Detailed description: 
      This a randomized control trial is designed to include (120) patients ASA physical status I
      ,II patients ranging from(18) to(60)years old scheduled for ophthalmic surgery

      Patients meeting the inclusion criteria will be randomly assigned to receive either:

      Group A: Laryseal pro supra glottic device (SGD) (n=60) Group B: Laryngeal Mask Airway-
      Proseal™ (n=60) Anesthesia management

      Preoperative procedures:

      After being accepted into the study, participants age, gender, weight, medications and any
      other co morbidities will be collected. patients will be allowed to fast for 6-8 h before
      surgery.

      After securing IV access by 20G cannula, all patients will receive 0.05mg/kg midazolam for
      anxiety. Ranitidine 50mg, metoclopramide 10mg and intravenous atropine 0.01 mg/kg as a
      premedication. Routine monitoring devices will be installed (basline blood pressure, heart
      rate, and pulse oximetry data) Proper airway assessment of the patients will be done
      according to El-Ganzouri Airway Scoring System(13) Intraoperative monitoring includes ASA
      standard monitoring Electrocardiography (ECG), noninvasive blood pressure, pulse oximetry for
      O2 saturation, end-tidal CO2 values by capnography

      Intraoperative procedures:

      Induction of general anaesthesia will be achieved by approximate doses according to ideal
      body weight of Fentanyl 1ug/kg, Propofol 2mg/kg and Atracurium 0.5mg/kg and Lidocaine 1mg/kg
      , 3 minutes of for oxygenation and mask ventilation before device insertion .

      Anesthesia maintenance will be achieved with the randomly assigned supraglottic device for
      each group which will be inserted and reconnected to the ventilator circuit., 2 minumium
      alveolar concentration of sevoflurane, volume-controlled mode ventilation, respiratory rate
      will be adjusted according to Et CO2 to range between 35-40 mmHg, a tidal volume of 6-8 ml/kg
      and mixture of gases in proportion 50% oxygen and 50% air

      The LMA-Proseal™ will be inserted using the digit method. The size will be determined
      according to the patient's weight and inserted according to the manufacture's recommendation
      (12) with the use of an introducer. The cuff will be inflated with air and the cuff's
      pressure will be adjusted to 70 mmHg using a cuff pressure manometer. the device will be
      lubricated well on both sides, head and neck were placed in neutral position, the proximal
      firmer part of the device will be compressed between the thumb and two fingers and advanced
      toward hard and soft palate, the tab will be pulled slightly if needed to increase curvature
      of the device for better fitting, the device will be advanced till resistance felt.

      For Laryseal pro SGD, the jaw will be lifted during insertion and the head will be extended,
      proper lubrication of both the front and back of the laryseal pro as if the patient's mouth
      is dry the laryseal pro ridges can get hung up on the back of the tongue during placement.
      The laryseal pro SP will be advanced at a forward angle aiming for the back of the tongue and
      soft palate. Then the colored connector will be pushed by index finger till feeling
      resistance . Device insertion will be considered successful by observing bilateral chest wall
      movement as well as a stable square-wave capnogram trace. Failed device placement will be
      defined as being unable to observe a smooth square-wave capnograph, inadequate ventilation,
      no rise of the chest wall, and significant leakage from the gastric drain tube If, after two
      attempts, the device not properly inserted, endotracheal intubation will be done and those
      patients will be excluded from the study.

      Insertion time of the study device will be recorded for each device which is defined as time
      interval between picking the device up till appearance of the ﬁrst wave on the capnogram.

      The ease of insertion will be classified based on insertion attempts (1 = first attempt, 2 =
      second attempt, 3 = third attempt, 4 = impossible) The vital signs(heart rate and mean blood
      pressure) will be recorded; just prior to device insertion (T1); after connection to
      capnography (T2), to assess the pressor response during device insertion The airway seal
      pressure will be assessed for each device , measured with head in the neutral position, under
      manual ventilation by closing the adjustable pressure-limiting (APL) valve to 30 cmH2O
      adjustable pressure-limiting (APL) valve to 30 cmH2O at a fixed gas flow of 3 L.min-1 , 7,
      and observing of the rise of the ventilator's airway pressure[14]. A "puffing" sound will be
      heard near the patient's mouth (release of pressure) indicating the airway seal pressure.

      Once patients reconnected to the ventilator circuit, a gastric tube will be introduced
      through the integrated drainage channel present in both devices. To standardize the
      technique, the same brand gastric tube will be used for both devices. The success rate of its
      insertion will be recorded. Ease of gastric tube insertion will be graded on a three-point
      scale (1 = first attempt, 2 = second attempt and 3 = impossible). After venting the stomach
      the blocker will be introduced and inflated to achieve proper sealing. The surgery will be
      allowed to proceed after ensuring proper positioning and sealing of the device.

      At the end of surgery, adequate reversal of residual neuromuscular blockade will be achieved
      The device will be removed and checked for any blood streaked mucous as a sign of airway
      trauma. Post-operative sore throat or hoarseness of voice will be assessed at 0, 2 and 4 h.
      Any regurgitation , pulmonary aspiration, bronchospasm , hypoxemia will be also recorded.
    

Intervention name(s): Laryseal pro supra glottic device; Laryngeal Mask Airway- Proseal™
Intervention type(s): Device; Device
Intervention description(s): The laryseal pro SP will be advanced at a forward angle aiming for the back of the tongue and soft palate. Then the colored connector will be pushed by index finger till feeling resistance . Device insertion will be considered successful by observing bilateral chest wall movement as well as a stable square-wave capnogram trace; The cuff will be inflated with air and the cuff's pressure will be adjusted to 70 mmHg using a cuff pressure manometer. the device will be lubricated well on both sides, head and neck were placed in neutral position, the proximal firmer part of the device will be compressed between the thumb and two fingers and advanced toward hard and soft palate, the tab will be pulled slightly if needed to increase curvature of the device for better fitting, the device will be advanced till resistance felt.
Other intervention name(s): supra glottic device; supra glottic device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic