Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly
      obese patients is maintained through the ventilator, will be studied. Researchers suggest
      that the technique will allow more time for intubation trial rather than conventional
      techniques of intubation without ventilation. the Primary outcome will be the decrease of
      desaturation events during intubation. Secondary variables will include; stress response to
      intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful
      intubation, the time required to intubation and operator satisfaction.
    

Detailed description: 
      All patients will be subjected to a thorough preoperative evaluation including clinical
      assessment, ECG, Echocardiography, pulmonary function tests and laboratory investigations
      (CBC, SGOT, SGPT, Albumin, Serum creatinine) and basal arterial blood gases. All patients
      will be pre-medicated with intravenous infusion of pantoprazole (40 mg) and metoclopramide
      (10 mg). After pre-oxygenation with 100% oxygen for 5 minutes, anesthesia will be induced
      using propofol (1-2 mg/kg) preceded by 60 mgs of lidocaine, and rocronium (0.12 mg/kg). Mask
      ventilation will be maintained while a Boussignac valve is attached between the Y-circuit and
      the face mask. After full relaxation is achieved (60 second after TOF response disappears),
      intubation attempt will commence.

      Intubation technique:

      Patients of both, patients will be put in HELP position to facilitate both ventilation and
      incubation

        -  In C group: mask ventilation will be terminated then FOB intubation will be done by
           experienced anesthist.

        -  In B group: Mask ventilation will be continued and FOB intubation will be performed from
           Boussignac valve opening.

      Data collection:

      Patient demographic data (Age, Weight, height, BMI, ASA status, coexisting diseases) will be
      collected. Hemodynamic parameters will be r5ecorded at the following points (Preoperative,
      basal, 1,2,3 minutes after starting intubation attempt).

      Time to successful intubation will be documented in seconds (starting from passing of FOB
      through mouth opening till successful placement of the tube in the trachea). Also, time to
      glottis visualization and time to carina visualization will be recorded. Number of attempts
      will be also recorded where unsuccessful attempt will be defined as the need to withdraw FOB
      outside the patient's mouth (either due to failure to progress or need for ventilation). a
      desaturation event will be defined as SpO2 less than 94. Also, any procedure-related
      complication will be documented (hypertension, arrhythmia, spasm, bleeding) Statistical
      analysis G*power software version 3.1.9.2 was used for sample size calculation. We assumed
      that using Boussignac valve during FOB intubation can produce a 20% increase in the time to
      reach patients spo2 of 95% (180±20 sec in previous studies). It was found that 16 patients
      per was required to achieve a power of 90% with an alpha error of 0.05. additional 4 patients
      were added to compensate or dropouts making a total sample size of 40 patients.

      Data will be collected and tabulated in excel sheet (Microsoft office, 2016). Statistical
      analysis will be performed using SPSS software version 20. Continuous data will be tested for
      normality of distribution and presented as mean±SD or median (interquartile range).
      Statistical differences between the studied groups will be assessed using appropriate
      statistical tests
    

Intervention name(s): Fibroptic intubation through Boussignac valve opening; Classic Fibroptic intubation
Intervention type(s): Device; Device
Intervention description(s): After patients being put in HELP position to facilitate both ventilation and intubation, mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening.; After patients being put in HELP position to facilitate both ventilation and incubation, mask ventilation will be terminated then FOB intubation will be done by an experienced anesthetist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment