Airway Complication of AnaesthesiaNCT02372760
For A More Comfortable Bronchoscopy: Is Spray Catheter The Answer?
A study testing BA by spray catheter (Olympus PW-205V), BA classic anesthesia and Anesthesia in people with Airway Complication of Anaesthesia, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Complication of Anaesthesia
- What is being tested?
- BA by spray catheter (Olympus PW-205V), BA classic anesthesia and Anesthesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years of age and above)
- Not mechanically ventilated
- Needing a bronchoscopy as determined by a referring or consulting physician/medical service
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Bronchoscopy is a commonly performed procedure for inpatients. It is routinely done for both diagnostic and therapeutic purposes. The physician in this procedure inserts the bronchoscopy tube that has a camera at its tip to visualize the airways and detect possible pathologies. When needed, he/she can take samples (biopsies), perform brochoalveolar lavage, remove foreign bodies, or relieve airway obstructions.
The usual method of Bronchoscopic Anesthesia (BA) is conscious sedation combined with local anesthesia as it's more comfortable for the patients, with less chances of lidocaine toxicity. Local anesthesia is classically done using lidocaine injected through the bronchoscope's working channel. As the operator starts from the upper airway, they anesthetize each part as they go down to examine the lungs. The lidocaine will be delivered to the airway as it drips out of the working channel into the airway part closest to it. Side effects of this method is cough with varying frequencies/severity that may sometimes hinder the procedure.
Recently, a spray catheter was designed and used, but mainly for EBUS (Endobronchial Ultrasound) and not for bronchoscopy.
- Conditions
- Airway Complication of Anaesthesia
- Being tested
- BA by spray catheter (Olympus PW-205V), BA classic anesthesia, Anesthesia
- Keywords
- Bronchoscopic anesthesia lidocaine, Spray Catheter, brochoalveolar lavage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BA by spray catheter (Olympus PW-205V)Device
Also called Spray catheter
This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)
BA classic anesthesiaOther
This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
AnesthesiaDrug
Also called Lidocaine
Both groups will receive lidocaine as the anesthesia for bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: BA classic anesthesia; Drug: Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of coughing episodes during the bronchoscopy
Coughing data will be collected from both groups during the bronchoscopy
Measured: Day 1
Severity of cough during the bronchoscopy
Severity of cough data will be collected from both groups during the bronchoscopy
Measured: Day 1
Endotracheal sedations required to conduct the bronchoscopy
Endotracheal sedations required to conduct the bronchoscopy between the two groups.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: The PI has relocated and the study has been closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnaesthesiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adil Shujaat, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372760
- Sponsor's protocol ID
- UFJ 2014-47
- Status last verified
- Dec 2015
- First submitted
- 3 Feb 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16162784De 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.
PubMed 23168547Jakobsen 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.
PubMed 2038931Antoniades 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.
PubMed 19703068Lee 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.
PubMed 20920136Kenzaki 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.
PubMed 15250225Wahidi 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.
PubMed 22045879Du 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.
PubMed 23860341
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- For A More Comfortable Bronchoscopy: Is Spray Catheter The Answer?
- ClinicalTrials.gov ID
- NCT02372760
- Acronym / sponsor ID
- UFJ 2014-47
- Conditions
- Airway Complication of Anaesthesia
- Keywords
- Bronchoscopic anesthesia lidocaine, Spray Catheter, brochoalveolar lavage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI has relocated and the study has been closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Bronchoscopy is a commonly performed procedure for inpatients. It is routinely done for both diagnostic and therapeutic purposes. The physician in this procedure inserts the bronchoscopy tube that has a camera at its tip to visualize the airways and detect possible pathologies. When needed, he/she can take samples (biopsies), perform brochoalveolar lavage, remove foreign bodies, or relieve airway obstructions.
The usual method of Bronchoscopic Anesthesia (BA) is conscious sedation combined with local anesthesia as it's more comfortable for the patients, with less chances of lidocaine toxicity. Local anesthesia is classically done using lidocaine injected through the bronchoscope's working channel. As the operator starts from the upper airway, they anesthetize each part as they go down to examine the lungs. The lidocaine will be delivered to the airway as it drips out of the working channel into the airway part closest to it. Side effects of this method is cough with varying frequencies/severity that may sometimes hinder the procedure.
Recently, a spray catheter was designed and used, but mainly for EBUS (Endobronchial Ultrasound) and not for bronchoscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BA by spray catheter (Olympus PW-205V) | Experimental | Device: BA by spray catheter (Olympus PW-205V), Drug: AnesthesiaThis group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V). |
| BA classic anesthesia | Active comparator | Other: BA classic anesthesia, Drug: AnesthesiaThis group will be having the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (18 years of age and above)
- Not mechanically ventilated
- Needing a bronchoscopy as determined by a referring or consulting physician/medical service
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BA by spray catheter (Olympus PW-205V)Also: Spray catheterThis group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V) | Device | BA by spray catheter (Olympus PW-205V) |
| BA classic anesthesiaThis group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel. | Other | BA classic anesthesia |
| AnesthesiaAlso: LidocaineBoth groups will receive lidocaine as the anesthesia for bronchoscopy | Drug | BA by spray catheter (Olympus PW-205V), BA classic anesthesia |
Primary outcome
Number of coughing episodes during the bronchoscopy
Time frame: Day 1
Coughing data will be collected from both groups during the bronchoscopy
Severity of cough during the bronchoscopy
Time frame: Day 1
Severity of cough data will be collected from both groups during the bronchoscopy
Endotracheal sedations required to conduct the bronchoscopy
Time frame: Day 1
Endotracheal sedations required to conduct the bronchoscopy between the two groups.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
- Background: PubMed 16162784Stolz 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.
- Background: PubMed 23168547De 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.
- Background: PubMed 2038931Jakobsen 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.
- Background: PubMed 19703068Antoniades 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.
- Background: PubMed 20920136Lee 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.
- Background: PubMed 15250225Kenzaki 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.
- Background: PubMed 22045879Wahidi 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.
- Background: PubMed 23860341Du 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adil Shujaat, MD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BA by spray catheter (Olympus PW-205V), BA classic anesthesia and Anesthesia in people with Airway Complication of Anaesthesia, run by University of Florida at 1 site in United States.
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 3 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: withdrawn, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of coughing episodes during the bronchoscopy (time frame: Day 1). The study lists 3 primary outcomes in all. 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 NCT02372760, which also lists 8 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 3 Dec 2015.