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COVID lack of cases/recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical lidocaine | Drug | 1% lidocaine topically applied in 4 mL aliquots |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cough | Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-procedure Sore Throat | sore throat was self reported by patient as: none, mild, moderate, severe | 1 day |
| Number of Participants With Post-Procedure Subjective Cough |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Toth | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17036 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29346249 | Background | 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. | |
| 16162784 | Background |
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Participants will be Identified from pool of patients who will already be undergoing with planned flexible bronchoscopy and/or endobronchial ultrasound by an interventional pulmonologist in the operating room setting. They will be identified by review of the operating room schedule and through the interventional pulmonology clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Lidocaine | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots |
| FG001 | Nebuliser Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2019 |
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| Nebuliser solution | Drug | 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer |
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| Nebuliser Suspension | Drug | 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
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Subjective cough as described by patient as: none, mild, moderate, severe
| 1 day |
| Anesthesia Time to Wake up | time in minutes from scope out until ready for transport to post anesthesia care unit | 1 day |
| Alfentanyl Dosing | Total alfentanyl dosing by anesthesia in mcg/kg | 1 day |
| Propofol Dosing | Total propofol dosing by anesthesia in mg/kg | 1 day |
| Fentanyl Dosing | total fentanyl dosing by anesthesia in mcg/kg | 1 day |
| 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. |
| 22045879 | Background | 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. |
| 27614989 | Background | Dreher 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. |
| 28891835 | Result | Amini 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. |
2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer |
| FG002 | Atomizer Solution | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Lidocaine | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots |
| BG001 | Nebuliser Solution | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer |
| BG002 | Atomizer Solution | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Smoking History | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cough | Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl | Posted | Mean | Standard Deviation | coughs | 1 day |
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| Secondary | Number of Participants With Post-procedure Sore Throat | sore throat was self reported by patient as: none, mild, moderate, severe | The analysis population does not include subjects who left clinic prior to collection of this data | Posted | Count of Participants | Participants | 1 day |
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| Secondary | Number of Participants With Post-Procedure Subjective Cough | Subjective cough as described by patient as: none, mild, moderate, severe | The analysis population does not include subjects who left clinic prior to collection of this data. | Posted | Count of Participants | Participants | 1 day |
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| Secondary | Anesthesia Time to Wake up | time in minutes from scope out until ready for transport to post anesthesia care unit | Posted | Mean | Standard Deviation | minutes | 1 day |
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| Secondary | Alfentanyl Dosing | Total alfentanyl dosing by anesthesia in mcg/kg | Posted | Mean | Standard Deviation | mcg/kg | 1 day |
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| Secondary | Propofol Dosing | Total propofol dosing by anesthesia in mg/kg | Posted | Mean | Standard Deviation | mg/kg | 1 day |
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| Secondary | Fentanyl Dosing | total fentanyl dosing by anesthesia in mcg/kg | Posted | Mean | Standard Deviation | mcg/kg | 1 day |
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Data collected in the post-anesthesia care unit up to 1 hour after procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Topical Lidocaine | 16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus. Topical lidocaine: 1% lidocaine topically applied in 4 mL aliquots | 0 | 15 | 0 | 15 | 0 | 15 |
| EG001 | Nebuliser Solution | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes. Nebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Nebuliser Suspension | 2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes. Nebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer | 0 | 7 | 0 | 7 | 0 | 7 |
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The target enrollment was not reached secondary to the COVID-19 pandemic.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zoulfira Nisnevitch-Savarese, M.D. | Penn State Hershey Medical Center | 717-531-6597 | znisnevitchsavarese@pennstatehealth.psu.edu |
| Aug 19, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004864 | Equipment and Supplies |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| quit smoking |
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| never smoked |
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