Bronchiectasis Adult, Mediastinal Lymphadenopathy, Pneumonia, Chest--Diseases, Infiltrates, Bronchopulmonary Disease, Cancer, Lung
Conditions
Brief 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.
Interventions
1% lidocaine topically applied in 4 mL aliquots
DRUGNebuliser solution
2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
DRUGNebuliser Suspension
2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough | 1 day | Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Post-procedure Sore Throat | 1 day | sore throat was self reported by patient as: none, mild, moderate, severe |
| Number of Participants With Post-Procedure Subjective Cough | 1 day | Subjective cough as described by patient as: none, mild, moderate, severe |
| Alfentanyl Dosing | 1 day | Total alfentanyl dosing by anesthesia in mcg/kg |
| Propofol Dosing | 1 day | Total propofol dosing by anesthesia in mg/kg |
| Fentanyl Dosing | 1 day | total fentanyl dosing by anesthesia in mcg/kg |
| Anesthesia Time to Wake up | 1 day | time in minutes from scope out until ready for transport to post anesthesia care unit |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| 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 | 7 |
| 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 | 7 |
| Total | 29 |
Baseline characteristics
| Characteristic | Topical Lidocaine | Nebuliser Solution | Atomizer Solution | Total |
|---|---|---|---|---|
| Age, Continuous | 66.80 years STANDARD_DEVIATION 12.81 | 55.57 years STANDARD_DEVIATION 16.83 | 57.43 years STANDARD_DEVIATION 14.77 | 61.83 years STANDARD_DEVIATION 14.75 |
| BMI | 30.19 kg/m^2 STANDARD_DEVIATION 6.93 | 29.39 kg/m^2 STANDARD_DEVIATION 4.84 | 28.53 kg/m^2 STANDARD_DEVIATION 8.23 | 29.59 kg/m^2 STANDARD_DEVIATION 6.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 6 Participants | 6 Participants | 27 Participants |
| Region of Enrollment United States | 15 participants | 7 participants | 7 participants | 29 participants |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 3 Participants | 15 Participants |
| Smoking History currently smoking | 4 Participants | 3 Participants | 1 Participants | 8 Participants |
| Smoking History never smoked | 4 Participants | 2 Participants | 4 Participants | 10 Participants |
| Smoking History quit smoking | 7 Participants | 2 Participants | 2 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 0 / 15 | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 15 | 0 / 7 | 0 / 7 |
Outcome results
Primary
Cough
Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine | Cough | 1.20 coughs | Standard Deviation 1.7 |
| Nebuliser Solution | Cough | 1.71 coughs | Standard Deviation 1.6 |
| Atomizer Solution | Cough | 1.00 coughs | Standard Deviation 1 |
Secondary
Alfentanyl Dosing
Total alfentanyl dosing by anesthesia in mcg/kg
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine | Alfentanyl Dosing | 16.61 mcg/kg | Standard Deviation 22.64 |
| Nebuliser Solution | Alfentanyl Dosing | 47.99 mcg/kg | Standard Deviation 37.41 |
| Atomizer Solution | Alfentanyl Dosing | 4.40 mcg/kg | Standard Deviation 7.42 |
Secondary
Anesthesia Time to Wake up
time in minutes from scope out until ready for transport to post anesthesia care unit
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine | Anesthesia Time to Wake up | 8.47 minutes | Standard Deviation 4.02 |
| Nebuliser Solution | Anesthesia Time to Wake up | 13.00 minutes | Standard Deviation 5.77 |
| Atomizer Solution | Anesthesia Time to Wake up | 6.14 minutes | Standard Deviation 3.8 |
Secondary
Fentanyl Dosing
total fentanyl dosing by anesthesia in mcg/kg
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine | Fentanyl Dosing | 0.30 mcg/kg | Standard Deviation 0.28 |
| Nebuliser Solution | Fentanyl Dosing | 0.24 mcg/kg | Standard Deviation 0.23 |
| Atomizer Solution | Fentanyl Dosing | 0.48 mcg/kg | Standard Deviation 0.39 |
Secondary
Number of Participants With Post-procedure Sore Throat
sore throat was self reported by patient as: none, mild, moderate, severe
Time frame: 1 day
Population: The analysis population does not include subjects who left clinic prior to collection of this data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Lidocaine | Number of Participants With Post-procedure Sore Throat | none | 6 Participants |
| Topical Lidocaine | Number of Participants With Post-procedure Sore Throat | mild | 4 Participants |
| Topical Lidocaine | Number of Participants With Post-procedure Sore Throat | moderate | 1 Participants |
| Topical Lidocaine | Number of Participants With Post-procedure Sore Throat | severe | 0 Participants |
| Nebuliser Solution | Number of Participants With Post-procedure Sore Throat | severe | 0 Participants |
| Nebuliser Solution | Number of Participants With Post-procedure Sore Throat | none | 4 Participants |
| Nebuliser Solution | Number of Participants With Post-procedure Sore Throat | moderate | 2 Participants |
| Nebuliser Solution | Number of Participants With Post-procedure Sore Throat | mild | 0 Participants |
| Atomizer Solution | Number of Participants With Post-procedure Sore Throat | severe | 0 Participants |
| Atomizer Solution | Number of Participants With Post-procedure Sore Throat | mild | 3 Participants |
| Atomizer Solution | Number of Participants With Post-procedure Sore Throat | moderate | 1 Participants |
| Atomizer Solution | Number of Participants With Post-procedure Sore Throat | none | 2 Participants |
Secondary
Number of Participants With Post-Procedure Subjective Cough
Subjective cough as described by patient as: none, mild, moderate, severe
Time frame: 1 day
Population: The analysis population does not include subjects who left clinic prior to collection of this data.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Lidocaine | Number of Participants With Post-Procedure Subjective Cough | none | 1 Participants |
| Topical Lidocaine | Number of Participants With Post-Procedure Subjective Cough | mild | 8 Participants |
| Topical Lidocaine | Number of Participants With Post-Procedure Subjective Cough | moderate | 2 Participants |
| Topical Lidocaine | Number of Participants With Post-Procedure Subjective Cough | severe | 0 Participants |
| Nebuliser Solution | Number of Participants With Post-Procedure Subjective Cough | severe | 0 Participants |
| Nebuliser Solution | Number of Participants With Post-Procedure Subjective Cough | none | 1 Participants |
| Nebuliser Solution | Number of Participants With Post-Procedure Subjective Cough | moderate | 1 Participants |
| Nebuliser Solution | Number of Participants With Post-Procedure Subjective Cough | mild | 4 Participants |
| Atomizer Solution | Number of Participants With Post-Procedure Subjective Cough | severe | 0 Participants |
| Atomizer Solution | Number of Participants With Post-Procedure Subjective Cough | mild | 3 Participants |
| Atomizer Solution | Number of Participants With Post-Procedure Subjective Cough | moderate | 1 Participants |
| Atomizer Solution | Number of Participants With Post-Procedure Subjective Cough | none | 2 Participants |
Secondary
Propofol Dosing
Total propofol dosing by anesthesia in mg/kg
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Topical Lidocaine | Propofol Dosing | 5.30 mg/kg | Standard Deviation 3.23 |
| Nebuliser Solution | Propofol Dosing | 6.93 mg/kg | Standard Deviation 3.36 |
| Atomizer Solution | Propofol Dosing | 3.26 mg/kg | Standard Deviation 0.81 |