NCT02372760

Brief Summary

Bronchoscopy is a commonly performed procedure for inpatients to visualize the airways when indicated. It is routinely done for both diagnostic (to lavage and biopsy the respiratory tract) and therapeutic purposes (to relief an obstruction or remove foreign bodies). Given the possible side effects of cough of varying severity this procedure can be uncomfortable to patients, some would even shy away from having a bronchoscopy even when it's medically indicated. Recently a spray catheter was designed to deliver more uniform anesthesia to the airways as compared to the conventional way of injecting the anesthesia into the bronchoscopy working channel. The investigators aim to conduct this study with the hope of improving patient care, providing comfortable procedures, helping more patients opt in for bronchoscopy when indicated.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

February 3, 2015

Last Update Submit

December 1, 2015

Conditions

Airway Complication of Anaesthesia

Keywords

Bronchoscopic anesthesia lidocaineSpray Catheterbrochoalveolar lavage

Outcome Measures

Primary Outcomes (3)

  • Number of coughing episodes during the bronchoscopy

    Coughing data will be collected from both groups during the bronchoscopy

    Day 1

  • Severity of cough during the bronchoscopy

    Severity of cough data will be collected from both groups during the bronchoscopy

    Day 1

  • Endotracheal sedations required to conduct the bronchoscopy

    Endotracheal sedations required to conduct the bronchoscopy between the two groups.

    Day 1

Study Arms (2)

BA by spray catheter (Olympus PW-205V)

EXPERIMENTAL

This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V).

Device: BA by spray catheter (Olympus PW-205V)Drug: Anesthesia

BA classic anesthesia

ACTIVE COMPARATOR

This group will be having the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.

Other: BA classic anesthesiaDrug: Anesthesia

Interventions

BA by spray catheter (Olympus PW-205V)DEVICE

This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)

Also known as: Spray catheter
BA by spray catheter (Olympus PW-205V)
BA classic anesthesiaOTHER

This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.

BA classic anesthesia
AnesthesiaDRUG

Both groups will receive lidocaine as the anesthesia for bronchoscopy

Also known as: Lidocaine
BA by spray catheter (Olympus PW-205V)BA classic anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18 years of age and above)
  • Not mechanically ventilated
  • Needing a bronchoscopy as determined by a referring or consulting physician/medical service

You may not qualify if:

  • Individuals below 18 years of age
  • Pregnant women
  • Terminally-ill patients
  • Patients who are unable to consent in person
  • Patients with contraindications for bronchoscopy (according to British Thoracic Society 2013 Guidelines this includes patients with acute myocardial infarction and patients in acute respiratory distress)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health

Jacksonville, Florida, 32209, United States

Location

Related Publications (8)

  • Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.

    PMID: 16162784BACKGROUND

  • De S. Assessment of patient satisfaction and lidocaine requirement during flexible bronchoscopy without sedation. J Bronchology Interv Pulmonol. 2009 Jul;16(3):176-9. doi: 10.1097/LBR.0b013e3181afca25.

    PMID: 23168547BACKGROUND

  • Jakobsen CJ, Ahlburg P, Holdgard HO, Olsen KH, Thomsen A. Comparison of intravenous and topical lidocaine as a suppressant of coughing after bronchoscopy during general anesthesia. Acta Anaesthesiol Scand. 1991 Apr;35(3):238-41. doi: 10.1111/j.1399-6576.1991.tb03280.x.

    PMID: 2038931BACKGROUND

  • Antoniades N, Worsnop C. Topical lidocaine through the bronchoscope reduces cough rate during bronchoscopy. Respirology. 2009 Aug;14(6):873-6. doi: 10.1111/j.1440-1843.2009.01587.x.

    PMID: 19703068BACKGROUND

  • Lee HJ, Haas AR, Sterman DH, Solly R, Vachani A, Gillespie CT. Pilot randomized study comparing two techniques of airway anaesthesia during curvilinear probe endobronchial ultrasound bronchoscopy (CP-EBUS). Respirology. 2011 Jan;16(1):102-6. doi: 10.1111/j.1440-1843.2010.01861.x.

    PMID: 20920136BACKGROUND

  • Kenzaki K, Hirose Y, Tamaki M, Sakiyama S, Kondo K, Mutsuda T, Monden Y. Novel bronchofiberscopic catheter spray device allows effective anesthetic spray and sputum suctioning. Respir Med. 2004 Jul;98(7):606-10. doi: 10.1016/j.rmed.2004.01.002.

    PMID: 15250225BACKGROUND

  • Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.

    PMID: 22045879BACKGROUND

  • 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. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.

    PMID: 23860341BACKGROUND

MeSH Terms

Interventions

AnesthesiaLidocaine

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Adil Shujaat, MD

    University at Buffalo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 26, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

US(1)