Clinical trial NCT02646813: Comparison of Intra and Extraluminal Bronchial Blocker in Adults
Official title: A Comparison of Intraluminal and Extraluminal Placement of the Arndt Bronchial Blockers for Adult Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Operative, Non Cardiac, Thoracic Disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Time for placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally
timeFrame: <8 minutes
Secondary outcomes:
measure: Sore Throat
timeFrame: <48hrs postop
Other outcomes:
measure: Quality of Lung Isolation
timeFrame: Duration of surgery
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas W Templeton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clayton-Smith A, Bennett K, Alston RP, Adams G, Brown G, Hawthorne T, Hu M, Sinclair A, Tan J. A Comparison of the Efficacy and Adverse Effects of Double-Lumen Endobronchial Tubes and Bronchial Blockers in Thoracic Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):955-66. doi: 10.1053/j.jvca.2014.11.017. Epub 2014 Dec 2.
citation: Campos JH, Hallam EA, Van Natta T, Kernstine KH. Devices for lung isolation used by anesthesiologists with limited thoracic experience: comparison of double-lumen endotracheal tube, Univent torque control blocker, and Arndt wire-guided endobronchial blocker. Anesthesiology. 2006 Feb;104(2):261-6, discussion 5A. doi: 10.1097/00000542-200602000-00010.
citation: Knoll H, Ziegeler S, Schreiber JU, Buchinger H, Bialas P, Semyonov K, Graeter T, Mencke T. Airway injuries after one-lung ventilation: a comparison between double-lumen tube and endobronchial blocker: a randomized, prospective, controlled trial. Anesthesiology. 2006 Sep;105(3):471-7. doi: 10.1097/00000542-200609000-00009.
citation: Hsieh VC, Thompson DR, Haberkern CM. Pediatric endobronchial blockers in infants: a refinement in technique. Paediatr Anaesth. 2015 Apr;25(4):438-9. doi: 10.1111/pan.12568. No abstract available.
citation: Stephenson LL, Seefelder C. Routine extraluminal use of the 5F Arndt Endobronchial Blocker for one-lung ventilation in children up to 24 months of age. J Cardiothorac Vasc Anesth. 2011 Aug;25(4):683-6. doi: 10.1053/j.jvca.2010.04.020. Epub 2010 Jul 18. No abstract available.
citation: Bastien JL, O'Brien JG, Frantz FW. Extraluminal use of the Arndt pediatric endobronchial blocker in an infant: a case report. Can J Anaesth. 2006 Feb;53(2):159-61. doi: 10.1007/BF03021821.