Evaluation of a Disposable Flexible Bronchoscope, aScope IV

NCT02255838 | Terminated Results

• 1 other identifier: 14.0689
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Flexible bronchoscopes are typically reusable and therefore need high level disinfection to prevent inadvertent spread of microbial pathogens from patient to patient. The process of disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may not be readily available for another patient. One solution to this problem was to use a single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of the bronchoscope.(Colt, Beamis, Harrell, \& Mathur, 2000). Another way to eliminate potential hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen \& Fredensborg, 2013; Pujol, López, \& Valero, 2010; Tvede, Kristensen, \& Nyhus-Andreasen, 2012). Further advancement in the imaging and handling of this disposable flexible bronchoscope now allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients with pulmonary compromise. (FDA approval: 05-11-2013 date) The aim of the study is to compare image clarity, suction capacity, and handling performance of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the investigators intend to perform a cost analysis.

Conditions

Respiratory Insufficiency; Pneumonia; Atelectasis

Outcome Measures

Primary Outcomes (2)

• Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope

  Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization

  10 to 30 minutes

• Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope

  Handling of the two bronchoscopes using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization

  10-30 minutes

Secondary Outcomes (2)

• Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope

  10-30 minutes

• Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope

  10-30 minutes

Study Arms (2)

Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x)

EXPERIMENTAL

the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen.

Device: Bronchoscope disposable (aScope 4)

Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV)

ACTIVE COMPARATOR

the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen.

Device: Bronchoscope reusable (Storz 8402 2x)

Interventions

Bronchoscope reusable (Storz 8402 2x) DEVICE

Bronchoscopy and alveolar lavage

Also known as: Storz 8402 2x (Storz, El Segundo, CA)

Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV)

Bronchoscope disposable (aScope 4) DEVICE

Bronchoscopy and alveolar lavage

Also known as: aScope 4 (Ambu, Glen Burnie, MD)

Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult 18 years old and older
• Capable of giving informed consent or have an acceptable surrogate capable of giving legally authorized consent on the subject's behalf.
• Indication of a diagnostic and or therapeutic bronchoscopy as determined by the attending critical care physician
• Being cared for in the critical care units at the U of L Hospital

You may not qualify if:

• \) Patient is moribund and a bronchoscopy is very unlikely to reduce impending mortality or can avert death

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

Location

Related Publications (19)

• Bellomo R, Tai E, Parkin G. Fibreoptic bronchoscopy in the critically ill: a prospective study of its diagnostic and therapeutic value. Anaesth Intensive Care. 1992 Nov;20(4):464-9. doi: 10.1177/0310057X9202000412.

  PMID: 1463174 BACKGROUND

• Colt HG, Beamis JJ, Harrell JH, Mathur PM. Novel flexible bronchoscope and single-use disposable-sheath endoscope system. A preliminary technology evaluation. Chest. 2000 Jul;118(1):183-7. doi: 10.1378/chest.118.1.183.

  PMID: 10893377 BACKGROUND

• Estella A. [Analysis of 208 flexible bronchoscopies performed in an intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):396-401. doi: 10.1016/j.medin.2011.11.005. Epub 2011 Dec 20. Spanish.

  PMID: 22192316 BACKGROUND

• Facciolongo N, Patelli M, Gasparini S, Lazzari Agli L, Salio M, Simonassi C, Del Prato B, Zanoni P. Incidence of complications in bronchoscopy. Multicentre prospective study of 20,986 bronchoscopies. Monaldi Arch Chest Dis. 2009 Mar;71(1):8-14. doi: 10.4081/monaldi.2009.370.

  PMID: 19522159 BACKGROUND

• Georgiades G, Myrianthefs P, Venetsanou K, Kythreoti A, Kyroudi A, Kittas C, Baltopoulos G. Temperature and serum proinflammatory cytokine changes in patients with NSCLC after BAL. Lung. 2003;181(1):35-47. doi: 10.1007/s00408-003-1001-6.

  PMID: 12879338 BACKGROUND

• Huang YC, Bassett MA, Levin D, Montilla T, Ghio AJ. Acute phase reaction in healthy volunteers after bronchoscopy with lavage. Chest. 2006 Jun;129(6):1565-9. doi: 10.1378/chest.129.6.1565.

  PMID: 16778276 BACKGROUND

• Ikeda S, Yanai N, Ishikawa S. Flexible bronchofiberscope. Keio J Med. 1968 Mar;17(1):1-16. doi: 10.2302/kjm.17.1. No abstract available.

  PMID: 5674435 BACKGROUND

• Kreider ME, Lipson DA. Bronchoscopy for atelectasis in the ICU: a case report and review of the literature. Chest. 2003 Jul;124(1):344-50. doi: 10.1378/chest.124.1.344.

  PMID: 12853543 BACKGROUND

• Kristensen MS, Fredensborg BB. The disposable Ambu aScope vs. a conventional flexible videoscope for awake intubation -- a randomised study. Acta Anaesthesiol Scand. 2013 Aug;57(7):888-95. doi: 10.1111/aas.12094. Epub 2013 Mar 15.

  PMID: 23495767 BACKGROUND

• Lucena CM, Martinez-Olondris P, Badia JR, Xaubet A, Ferrer M, Torres A, Agusti C. [Fiberoptic bronchoscopy in a respiratory intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):389-95. doi: 10.1016/j.medin.2011.11.004. Epub 2011 Dec 22. Spanish.

  PMID: 22195599 BACKGROUND

• Perkins GD, Chatterjie S, McAuley DF, Gao F, Thickett DR. Role of nonbronchoscopic lavage for investigating alveolar inflammation and permeability in acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):57-64. doi: 10.1097/01.ccm.0000190197.69945.c5.

  PMID: 16374157 BACKGROUND

• Pujol E, Lopez AM, Valero R. Use of the Ambu((R)) aScope in 10 patients with predicted difficult intubation. Anaesthesia. 2010 Oct;65(10):1037-40. doi: 10.1111/j.1365-2044.2010.06477.x.

  PMID: 20707786 BACKGROUND

• Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. Summary of the British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults. Thorax. 2013 Aug;68(8):786-7. doi: 10.1136/thoraxjnl-2013-203629.

  PMID: 23842821 BACKGROUND

• Scutt S, Clark N, Cook TM, Smith C, Christmas T, Coppel L, Crewdson K. Evaluation of a single-use intubating videoscope (Ambu aScope ) in three airway training manikins for oral intubation, nasal intubation and intubation via three supraglottic airway devices. Anaesthesia. 2011 Apr;66(4):293-9. doi: 10.1111/j.1365-2044.2011.06647.x. Epub 2011 Feb 24.

  PMID: 21401543 BACKGROUND

• Sharif-Kashani B, Shahabi P, Behzadnia N, Mohammad-Taheri Z, Mansouri D, Masjedi MR, Zargari L, Salimi Negad L. Incidence of fever and bacteriemia following flexible fiberoptic bronchoscopy: a prospective study. Acta Med Iran. 2010 Nov-Dec;48(6):385-8.

  PMID: 21287478 BACKGROUND

• Steinberg KP, Mitchell DR, Maunder RJ, Milberg JA, Whitcomb ME, Hudson LD. Safety of bronchoalveolar lavage in patients with adult respiratory distress syndrome. Am Rev Respir Dis. 1993 Sep;148(3):556-61. doi: 10.1164/ajrccm/148.3.556.

  PMID: 8368623 BACKGROUND

• Tsao TC, Tsai YH, Lan RS, Shieh WB, Lee CH. Treatment for collapsed lung in critically ill patients. Selective intrabronchial air insufflation using the fiberoptic bronchoscope. Chest. 1990 Feb;97(2):435-8. doi: 10.1378/chest.97.2.435.

  PMID: 2298070 BACKGROUND

• Tvede MF, Kristensen MS, Nyhus-Andreasen M. A cost analysis of reusable and disposable flexible optical scopes for intubation. Acta Anaesthesiol Scand. 2012 May;56(5):577-84. doi: 10.1111/j.1399-6576.2012.02653.x. Epub 2012 Feb 16.

  PMID: 22338623 BACKGROUND

• Um SW, Choi CM, Lee CT, Kim YW, Han SK, Shim YS, Yoo CG. Prospective analysis of clinical characteristics and risk factors of postbronchoscopy fever. Chest. 2004 Mar;125(3):945-52. doi: 10.1378/chest.125.3.945.

  PMID: 15006953 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumonia; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Diseases

Results Point of Contact

• Title: Rainer Lenhardt
• Organization: University of Louisville

rainer.lenhardt@louisville.edu

5028523122

Study Officials

• Rainer Lenhardt, MD MBA

  University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A blinded investigator will view the bronchoscopy video and evaluate. The blinded investigator will use the same criteria the investigator who did the procedure used (Un-blinded) for the evaluation. Video will not indicate which scope was used and only indicate if it is the right or left lung they are viewing. Research coordinator will keep separate a file indicating which scope was used.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MBA

Model Details: The disposable aScope IV bronchoscope will be compared to the re-usable bronchoscope

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: October 3, 2014
• Study Start: April 1, 2015
• Primary Completion: January 14, 2020
• Study Completion: January 14, 2020
• Last Updated: April 26, 2022
• Results First Posted: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)