Comparison of Intra and Extraluminal Bronchial Blocker in Adults

Study Overview
=================
Brief 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.

Official Title
-----------------
A Comparison of Intraluminal and Extraluminal Placement of the Arndt Bronchial Blockers for Adult Thoracic Surgery

Conditions
-----------------
Operative, Non Cardiac, Thoracic Disease

Intervention / Treatment
-----------------
* Procedure: Intraluminal Placement
* Procedure: Extraluminal Placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 and <80 Patients scheduled for non cardiac, thoracic surgery requiring lung isolation Exclusion Criteria: History of difficult airway/intubation Patients suspected to have a difficult airway Morbid obesity BMI >39 Pregnancy Emergency status of surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intraluminal Placement<br>These patients will have the Arndt endobronchial blocker placed within the endotracheal tube for lung isolation during their thoracic surgery. The observer will measure time required to place blocker correctly prior to surgery. | Procedure: Intraluminal Placement<br>* Pt. will have Arndt Endobronchial Blocker placed intraluminally<br>|
| Experimental: Extraluminal Placement<br>These patients will have the Arndt endobronchial blocker placed outside of the endotracheal tube for lung isolation during their thoracic surgery. The investigator will measure the time required for placement. | Procedure: Extraluminal Placement<br>* Pt. will have Arndt Endobronchial Blocker placed extraluminally<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally |  | <8 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sore Throat | The investigator will query the study participants on post op days 1 and 2, and will use a qualitative scale from 1-4. 1-No Sore throat, 2-mild sorethroat, 3-moderate sorethroat, 4-severe sorethroat. The investigators will the compare means from the arms of the study. | <48hrs postop |