Bronchiectasis AdultPhase 3NCT03829618
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
A Phase 3 study testing Topical lidocaine, Nebuliser solution and Nebuliser Suspension in people with Bronchiectasis Adult and Mediastinal Lymphadenopathy, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis Adult, Mediastinal Lymphadenopathy, Pneumonia
- What is being tested?
- Topical lidocaine, Nebuliser solution and Nebuliser Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 31 Aug 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.
- Diagnosis of pulmonary disease requiring flexible bronchoscopy
- Greater than 18 years of age.
Who cannot join
- Any intervention beyond flexible bronchoscopy and endobronchial ultrasound
- Inability to tolerate bronchoscopy.
- Patients that receive paralytics.
- Patients with neuromuscular diseases.
- Inability to consent for procedures.
- Allergies to lidocaine or any other drugs used in protocol.
- Existing renal insufficiency or liver disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17036
About this study
The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.
- Conditions
- Bronchiectasis Adult, Mediastinal Lymphadenopathy, Pneumonia, Chest--Diseases, Infiltrates, Bronchopulmonary Disease
- Being tested
- Topical lidocaine, Nebuliser solution, Nebuliser Suspension
- Medical subject headings
- Pneumonia, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical lidocaineDrug
Also called Topical
1% lidocaine topically applied in 4 mL aliquots
Nebuliser solutionDrug
Also called Nebulizer
2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
Nebuliser SuspensionDrug
Also called Atomizer
2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Topical Lidocaine | Active comparator | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Receives: Drug: Topical lidocaine |
| Nebuliser Solution | Active comparator | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Receives: Drug: Nebuliser solution |
| Nebuliser Suspension | Active comparator | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Receives: Drug: Nebuliser Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
Measured: 1 day
Secondary outcomes (6)
Number of Participants With Post-procedure Sore Throat
sore throat was self reported by patient as: none, mild, moderate, severe
Measured: 1 day
Number of Participants With Post-Procedure Subjective Cough
Subjective cough as described by patient as: none, mild, moderate, severe
Measured: 1 day
Anesthesia Time to Wake up
time in minutes from scope out until ready for transport to post anesthesia care unit
Measured: 1 day
Alfentanyl Dosing
Total alfentanyl dosing by anesthesia in mcg/kg
Measured: 1 day
Propofol Dosing
Total propofol dosing by anesthesia in mg/kg
Measured: 1 day
Fentanyl Dosing
total fentanyl dosing by anesthesia in mcg/kg
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start1 Apr 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: COVID lack of cases/recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Toth, Milton S. Hershey Medical Center
- Investigators
- Jennifer Toth, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829618
- Sponsor's protocol ID
- STUDY00009727
- Status last verified
- Sep 2021
- First submitted
- 24 Jan 2019
- Last updated
- 12 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madan K, Biswal SK, Mittal S, Hadda V, Mohan A, Khilnani GC, Pandey RM, Guleria R. 1% Versus 2% Lignocaine for Airway Anesthesia in Flexible Bronchoscopy Without Lignocaine Nebulization (LIFE): A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2018 Apr;25(2):103-110. doi: 10.1097/LBR.0000000000000458.
PubMed 29346249Stolz 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 16162784Wahidi 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 22045879Dreher M, Cornelissen CG, Reddemann MA, Muller A, Hubel C, Muller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. doi: 10.1159/000449135. Epub 2016 Sep 10.
PubMed 27614989Amini S, Peiman S, Khatuni M, Ghalamkari M, Rahimi B. The Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial. J Bronchology Interv Pulmonol. 2017 Oct;24(4):263-267. doi: 10.1097/LBR.0000000000000385.
PubMed 28891835
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
- ClinicalTrials.gov ID
- NCT03829618
- Acronym / sponsor ID
- STUDY00009727
- Conditions
- Bronchiectasis Adult, Mediastinal Lymphadenopathy, Pneumonia, Chest--Diseases, Infiltrates, Bronchopulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID lack of cases/recruitment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Posted 12 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Lidocaine | Active comparator | Drug: Topical lidocaine16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. |
| Nebuliser Solution | Active comparator | Drug: Nebuliser solution2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. |
| Nebuliser Suspension | Active comparator | Drug: Nebuliser Suspension2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.
- Diagnosis of pulmonary disease requiring flexible bronchoscopy
- Greater than 18 years of age.
Key exclusion criteria (7 listed)
- Any intervention beyond flexible bronchoscopy and endobronchial ultrasound
- Inability to tolerate bronchoscopy.
- Patients that receive paralytics.
- Patients with neuromuscular diseases.
- Inability to consent for procedures.
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 |
|---|---|---|
| Topical lidocaineAlso: Topical1% lidocaine topically applied in 4 mL aliquots | Drug | Topical Lidocaine |
| Nebuliser solutionAlso: Nebulizer2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | Drug | Nebuliser Solution |
| Nebuliser SuspensionAlso: Atomizer2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer | Drug | Nebuliser Suspension |
Primary outcome
Cough
Time frame: 1 day
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
6 secondary outcomes
Number of Participants With Post-procedure Sore Throat
Time frame: 1 day
Number of Participants With Post-Procedure Subjective Cough
Time frame: 1 day
Anesthesia Time to Wake up
Time frame: 1 day
Alfentanyl Dosing
Time frame: 1 day
Propofol Dosing
Time frame: 1 day
Fentanyl Dosing
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29346249Madan K, Biswal SK, Mittal S, Hadda V, Mohan A, Khilnani GC, Pandey RM, Guleria R. 1% Versus 2% Lignocaine for Airway Anesthesia in Flexible Bronchoscopy Without Lignocaine Nebulization (LIFE): A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2018 Apr;25(2):103-110. doi: 10.1097/LBR.0000000000000458.
- 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 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 27614989Dreher M, Cornelissen CG, Reddemann MA, Muller A, Hubel C, Muller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. doi: 10.1159/000449135. Epub 2016 Sep 10.
- Results publication: PubMed 28891835Amini S, Peiman S, Khatuni M, Ghalamkari M, Rahimi B. The Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial. J Bronchology Interv Pulmonol. 2017 Oct;24(4):263-267. doi: 10.1097/LBR.0000000000000385.
- Individual participant dataSharing planned: No
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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.
Jennifer Toth principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical lidocaine, Nebuliser solution and Nebuliser Suspension in people with Bronchiectasis Adult and Mediastinal Lymphadenopathy, run by Milton S. Hershey Medical Center 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 7 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: stopped early, as of the sponsor's last update on 12 Oct 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cough (time frame: 1 day). 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 NCT03829618, which also lists 5 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 12 Oct 2021.