Comparison of Intra and Extraluminal Bronchial Blocker in Adults
Condition: Operative, Non Cardiac, Thoracic Disease
MeSH terms: Thoracic Diseases
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the time and ease of placement of an extra-luminal
      Arndt bronchial blocker versus placing it intra-luminally.

      An additional objective will be to assess if there are any other significant clinical
      differences between these two approaches to placement of the BB including overall quality of
      isolation, an increase in post-operatives sore throat, post-operative hoarseness, and
      increased incidence of needing to reposition the blocker
    

Detailed description: 
      Once the patient is recruited in the preoperative assessment clinic, this information will be
      relayed to the study investigators. On the day of surgery the patient will then be randomized
      using a random number generator and opaque envelope method for group allocation to either
      intra-luminal or extra-luminal placement of a bronchial blocker.

      The investigators will record age, height, weight, gender, American Society of Anesthesia
      Classification, type of surgery, sided of surgery, duration of surgery, duration, and
      anesthesia.

      An IV will be placed in the patient prior to going to the OR. Once in the OR the patient will
      have routine monitors placed. The patient will be pre-oxygenated with 100% O2 for 2 minutes
      and induced with Propofol and rocuronium 0.8 mg/kg. The patient will then be hand ventilated
      with 100% oxygen. 3 minutes after administration of rocuronium the patient will have direct
      laryngoscopy performed with by one of the cardiac anesthesia fellows who has practiced
      placement of the BB both intraluminally and extraluminally in the simulator 10 times for each
      technique.

      In the intra-luminal group the patient will be intubated with a 8.0 cuffed endotracheal
      tube(ETT). We will confirm endotracheal placement of the ETT via auscultation and ETCO2. The
      ETT will be secured at an appropriated depth, the blocker, y-piece, and flexible fiberoptic
      bronchoscope(FFB) set up will be assembled and placed onto the ETT in standard fashion
      recommended by the manufacturer for placement of an intra-luminal blocker. The fiberscope
      will then be advanced into the desired bronchus depending on the laterality of surgery. Once
      in place, the cuff will be inflated and isolation will be checked with auscultation. Time for
      initial bronchial blocker placement will be recorded from the point of the direct
      laryngoscopy(DL) to removal of the fiberscope after visualization of the bronchial
      blocker(BB) with the cuff inflated in the correct position.

      In the extra-luminal group the patient will have the 9 Fr BB placed into the glottis and
      advanced to a depth of approximately 25 cm. Prior to placement, the blocker will be bent to
      roughly 45 degrees 2 cm proximal to the cuff balloon to facilitate placement of the blocker.
      The patient will then be intubated with an 8.0 cuffed ETT. We will confirm endotracheal
      placement of the ETT via auscultation and ETCO2. The ETT cuff should not be inflated to
      assure smooth movement of the blocker.

      At this point a FFB will be introduced into the ETT to evaluate the position of the blocker.
      If the blocker is located in the correct mainstem bronchus the depth will be adjusted under
      direct vision. If it is not located on the correct side, the blocker will be withdrawn into
      the trachea and using a twisting motion will be manipulated and directed into the other side.
      Once in position the ETT cuff will be inflated. The BB cuff will be inflated and isolation
      will be checked with auscultation. Time for initial bronchial blocker placement will be
      recorded from the point of the DL to removal of the fiberscope after visualization of the BB
      with the cuff inflated in the correct position.

      Other intravascular lines such as a radial arterial line and additional peripheral IV may be
      placed at the discretion of the attending anesthesiologist.

      Following BB and line placement in both patient groups, the patient will be placed in the
      lateral position with the operative side up. Once in the final position prior to prepping and
      draping the blocker in both groups will be checked to make sure it is still correctly placed
      with a FFB. The blocker will be inflated under direct visualization and the patient will be
      placed on 100% O2.

      The patient will be prepped and draped. The wire loop will be left in place in all patients
      in case the blocker needs to be repositioned until the end of the procedure. The lung will be
      allowed to passively deflate.

      The surgeon will be queried as to the quality of isolation upon entry into the chest and this
      will be recorded. This will be based on a three point scale. Excellent, Fair, or Poor. This
      will be queried every 30 minutes for the duration of the procedure.

      We will record any episodes of loss of isolation and details of repositioning including times
      and the issue of malposition i.e. the blocker slipped out or slipped in too far or suddenly
      slipped into the other mainstem bronchus. We will record any episodes of ongoing desaturation
      which require the deflation of the BB cuff and ventilation of both lungs.

      At the conclusion of the intrathoracic portion of the procedure the BB cuff will be deflated
      and the lung on the operative side will be reinflated. The wire will be removed from the BB
      in both groups and the BB will be removed from the ETT in the intra-luminal group and the
      trachea in the extra-luminal group.

      The patient will be extubated according to normal clinical practices and will be taken to the
      post anesthesia care unit.

      The patient will be contacted on post-operative days 1 and 2 to assess for hoarseness and
      sore throat. The investigator will also record any significant morbidity or mortality events
      such as prolonged mechanical ventilation or cardiac arrest or stroke that may occur within
      the first 2 post-operative days.

      The study will be performed at Wake Forest Baptist Medical Center a tertiary academic medical
      center.
    

Intervention name(s): Intraluminal Placement; Extraluminal Placement
Intervention type(s): Procedure; Procedure
Intervention description(s): Pt. will have Arndt Endobronchial Blocker placed intraluminally; Pt. will have Arndt Endobronchial Blocker placed extraluminally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other