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Operative, Non Cardiac, Thoracic DiseaseNCT02646813

Comparison of Intra and Extraluminal Bronchial Blocker in Adults

A study testing Intraluminal Placement and Extraluminal Placement in people with Operative, Non Cardiac, Thoracic Disease, run by Wake Forest University Health Sciences.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Operative, Non Cardiac, Thoracic Disease
What is being tested?
Intraluminal Placement and Extraluminal Placement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
Feb 2016to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age greater than 18 and <80
  • Patients scheduled for non cardiac, thoracic surgery requiring lung isolation

Who cannot join

  • History of difficult airway/intubation
  • Patients suspected to have a difficult airway
  • Morbid obesity BMI >39
  • Pregnancy
  • Emergency status of surgery

About this study

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

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

Read the 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.

Being tested
Intraluminal Placement, Extraluminal Placement
Medical subject headings
Thoracic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraluminal PlacementProcedure or surgery

    Pt. will have Arndt Endobronchial Blocker placed intraluminally

  • Extraluminal PlacementProcedure or surgery

    Pt. will have Arndt Endobronchial Blocker placed extraluminally

Study groups in NCT02646813
Study groupRoleWhat they receive
Intraluminal PlacementActive comparatorThese 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.
Receives: Procedure: Intraluminal Placement
Extraluminal PlacementExperimentalThese 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.
Receives: Procedure: Extraluminal Placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally

    Measured: <8 minutes

Secondary outcomes (1)
  1. 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.

    Measured: <48hrs postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionAug 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02646813
Sponsor's protocol ID
IRB00035615
Status last verified
Aug 2018
First submitted
31 Dec 2015
Last updated
13 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25753765
  • 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.

    PubMed 16436844
  • 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.

    PubMed 16931978
  • 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.

    PubMed 25752792
  • 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.

    PubMed 20638871
  • 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.

    PubMed 16434756

Questions about this trial

What is this clinical trial studying?

A study testing Intraluminal Placement and Extraluminal Placement in people with Operative, Non Cardiac, Thoracic Disease, run by Wake Forest University Health Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time for placement of an extra-luminal Arndt bronchial blocker versus placing it intra-luminally (time frame: <8 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02646813, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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