Comparison of Endotracheal Intubation Using Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope (FIVE) in Obese Patients Undergoing Elective Surgeries Under General Anesthesia: A Randomized Controlled Trial
Condition: Flexible Fiberoptic Bronchoscopy Versus Flexible Intubation Video Endoscope FIVE in Obese Patients
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Tracheal intubation is one of the most common medical procedures performed in hospitals. On
      one hand, it is highly successful and easy to perform using a rigid laryngoscope. On the
      other hand, hypoxic brain damage and death may result rapidly if it is unsuccessful. This
      disastrous outcome happens when the airway cannot be secured by intubation and face mask
      ventilation becomes difficult.

      Careful preoperative evaluation to identify patients in whom tracheal intubation and mask
      ventilation may prove to be difficult can save lives.

      Over the past 40 years, different techniques of tracheal intubation have been introduced, the
      most effective under different conditions being fiberoptic intubation.

      The flexible intubation video endoscope is a relatively new device which delivers clear,
      pixel-free images without a Moiré pattern. The flexible intubation video endoscope can be
      directly connected to the C-MAC® monitor. Due to the Distal Chip technology the user enjoys a
      full-format direct video imaging with improved image quality with a resolution higher than
      fiberoptic bronchoscopy which has another disadvantage of being Fragile where Fibres can be
      broken or have transmission loss when wrapped around curves of only a few centimeters radius.

      After ethics approval and informed consent from patients, 60 obese patients aging from 20-60
      years will randomly allocated and divided into two groups each is (Thirty) patients in each
      group, using flexible intubation video endoscope(FIVE) in (group1) and fiberoptic
      bronchoscopy in (group 2).

      The study will compare the techniques for time of intubation, hemodynamic (SBP, DBP and HR)
      changes, success rate, number of attempts and complications in both groups.

      investigators expect from this study that flexible intubation video endoscope(FIVE) has
      become a good alternative and associated with better visualization of laryngeal structures in
      shorter time as compared to traditional flexible fiberoptic bronchoscopy.
    

Detailed description: 
      Airway management is considered a cardinal aspect of anesthetic practice and of emergency and
      intensive care medicine. Endotracheal intubation is a simple, safe, rapid and nonsurgical
      method that achieves all the objectives of airway management which include maintaining a
      patent airway, lung protection from aspiration and allows leak free ventilation during
      mechanical ventilation. Even though endotracheal intubation isn't a complication free
      procedure, some of them life-threatening. It is important to anesthesiologists to be alert to
      these complications and to have an effective plan to avoid and manage these complications
      when they occur .

      If a clear airway can't be guaranteed, it can be fatal. In 1990, an analysis of
      anesthesia-related closed claims in the USA declared that respiratory system adverse outcomes
      were the lone largest class of injury and that the percentage of death or catastrophic brain
      insult associated with it was much higher than that associated with cardiovascular
      problems.Since then, it became a priority to decrease the serious adverse outcomes associated
      with airway management; major protocols for difficult airway management have been defined,
      developing new reliable airway devices, and adequate monitoring of ventilation by pulse
      oximetry and capnography have become a standard. Thanks to these efforts, the incidence of
      these serious adverse outcomes is likely to be reduced, and airway management can now be
      considered as a safe procedure.

      Endotracheal intubation is still the "gold standard" in airway management . If with using
      traditional techniques or video-assisted techniques which can be used when there is
      intubation failure or anticipated difficult airway. Video-assisted techniques may help to
      increase intubation success.

      Video-assisted techniques allow to indirectly visualize the laryngeal structures with fiber
      optical or camera chip technique and to show the video picture on an external or built-in
      monitor.

      Fiberoptic intubation has been considered for a long time the gold standard technique for
      intubation when there is anticipated or known difficult airway or as a rescue device in can't
      intubate but can ventilate scenarios . Fibreoptic intubation can be a hard skill to teach,
      gain and keep.In this context, closed claims analysis has declared severe complications such
      as catastrophic brain insult and death occurred with anticipated difficult airway management
      and awake intubation. Therefore, it is considerable to develop simple, dependable, safe, and
      effective intubation devices.
    

Intervention name(s): Flexible fiberoptic bronchoscopy; Fexible intubation video endoscopy
Intervention type(s): Device; Device
Intervention description(s): Flexible fiberoptic bronchoscopy versus flexible intubation video endoscope regarding intubation time in obese patients; Fexible intubation video endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In this prospective randomized controlled study 60 patients with ASA physical status Ӏ-ӀӀ, aging 20-50 years will be randomly allocated into two groups, 30 patients in each group
Masking: None (Open Label)
Primary purpose: Basic Science