The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) for Short Diagnostic Bronchoscopy Procedures
Phase: NA
Conditions: Bronchoscopy
Sponsor: Stanford University

 
 
 
 
The Safety and Efficacy of the Transnasal Humidified Rapid-Insufflation 
Ventilatory Exchange (THRIVE) for Short Diagnostic Bronchoscopy Procedures 
Study Protocol 
NCT03086408 
February 21, 2017

STUDY PROTOCOL: THRIVE AND DIAGNOSTIC BRONCHOSCOPY  
 
 
 
 
 
Prepared by Vladimir Nekhendzy, M.D. 
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STUDY OBJECTIVES 
1. DETERMINING THE SAFETY AND EFFICACY OF THRIVE FOR SHORT DIAGNOSTIC BRONCHOSCOPIC PROCEDURES. 
THRIVE should improve glottic and tracheal exposure, operating conditions, decrease surgical time, and potentially lead to better patient 
outcomes.  The safety of THRIVE for short diagnostic bronchoscopy has not been formally investigated, and will be explored in this study. 
With the patient anesthetized, apneic, and adequately oxygenated with THRIVE, the build-up of carbon dioxide in patient’s blood (PaCO2) and 
ensuing acute hypercapnic acidosis will be the main factors limiting the duration of THRIVE administration. At present, the rate of PaCO2 rise 
with THRIVE has not been directly investigated, but is suggested to be 1.1 mm Hg per minute. It is expected that the short duration of 
diagnostic bronchoscopy procedures explored in this study will not lead to substantial rise of PaCO2. The PaCO2 rise to 70 mm Hg is 
considered a safe level for moderate hypercapnia in patients without significant comorbidities (see Exclusion Criteria).  
2. DETERMINING POSSIBLE BENEFICIAL EFFECT OF THRIVE ON IMMEDIATE POSTOPERATIVE RECOVERY, OPIOD CONSUMPTION, AND 
FUNCTIONAL RECOVERY. 
 
INCLUSION CRITERIA 
Subjects presenting for short diagnostic bronchoscopy procedures under general anesthesia, including patients after bone marrow transplant 
(BMT). 
 
EXCLUSION CRITERIA 
1. Patients with significantly decreased myocardial function. 
2. Patients with cardiac arrhythmias. 
3. Patients with significant peripheral vascular disease. 

STUDY PROTOCOL: THRIVE AND DIAGNOSTIC BRONCHOSCOPY  
 
 
 
 
 
Prepared by Vladimir Nekhendzy, M.D. 
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4. Patients with known significant cerebrovascular disease. 
5. Patients with significant renal insufficiency. 
6. Patients with electrolyte (K+, Ca++ abnormalities). 
7. Patients with increased intracranial pressure or reduced intracranial compliance. 
8. Patients with skull base defects. 
9. Patients with pulmonary hypertension. 
10. Immunocompromised patients. 
11. Patients with significant chronic lung diseases. 
12. Morbidly obese patients. 
13. Patients with severe and poorly controlled gatsroesophageal reflux disease. 
14. Patients with hiatal hernia and full stomach patients. 
15. Patient's refusal to participate in the study. 
16. Patients who do not understand English or mentally handicapped. 
17. Pregnant or breastfeeding patients. 
18. "BMT patients with SpO2 < 90% on supplemental nasal oxygen up to 6 l/min, or those requiring non-rebreather mask to keep SpO2 > 
90% will be excluded from the study." 
 
PROTOCOL AT A GLANCE AND STUDY END-POINTS 
1. Patients will be randomly assigned to either THRIVE or ETT/SGA (control group).  
2. Anesthetic management is standardized for both groups. 
3. Study end-points: per data collection sheet. 
 

STUDY PROTOCOL: THRIVE AND DIAGNOSTIC BRONCHOSCOPY  
 
 
 
 
 
Prepared by Vladimir Nekhendzy, M.D. 
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OPERATING ROOM PREPARATION 
 
1. All drugs, airway supplies, eye tape, per routine. 
2. 8.0 MLT ETT and SGA (i-Gel). 
3. Precut large Tegaderm for securing ETT to the chin in left corner of mouth. 
4. Four channel Alaris pump with:  
a. NS carrier at 50 ml/hr 
b. Propofol drip 
c. Remifentanil drip 
5. 20 ml NS syringe in line for chasing the induction and IVP drugs intraop. Please minimize IVF beyond 10 ml/kg total due to high 
incidence of urinary retention in male patients. 
6. Working PNS with pads (make sure the battery is fresh). 
7. Sedline or BIS.  
 
 
 
 

STUDY PROTOCOL: THRIVE AND DIAGNOSTIC BRONCHOSCOPY  
 
 
 
 
 
Prepared by Vladimir Nekhendzy, M.D. 
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THRIVE GROUP 
CONTROL GROUP 
PREOP and 
PREMEDICATION 
 Obtain (check for) patient’s consent. 
 Randomize the patient to either THRIVE or CONTROL group.  
 Obtain preop QoR15.  
 Peripheral IV, 20 g. 
 Midazolam 0.007 mg/kg incremental doses to achieve sufficient anxiolysis, not to exceed 0.025 mg/kg total 
dose. For elderly patients (70-80 y.o), limit total dose of Midazolam to 0.5 mg. 
 
PRE-INDUCTION: 
Place standard ASA monitors, Sedline (BIS), and peripheral nerve stimulator (TOF ulnar nerve) 
 Apply THRIVE (FiO2 1.0) at 30 l/min.  
 Make sure the patient’s head is elevated 30-40° (table 
in BACK UP position, not reverse Trendelenburg). 
Preoxygenate. 
 IV fluid loading completed: 5 ml/kg. 
 IV Glycopyrrolate 0.2 mg if HR ≤ 50 bpm for elderly patients (70-80 y.o.).  
 Assure all bronchoscopy supplies are ready for immediate use in THRIVE group. 
    Both anesthesia and surgical time-outs completed. 
INDUCTION 
 IV Remifentanil 1 mcg/kg, Propofol 2mg/kg IV, Rocuronium 0. 6mg/kg IV. 
 Additional Remifentanil 0.5 mcg/kg and/or Propofol 0.5 mg/kg IV boluses, as required per hemodynamic 
responses and Sedline/BIS readings. 
 
 Turn THRIVE to 70 l/min.  
 Maintain jaw thrust, with oral airway as necessary, 
throughout the procedure. 
 
 
 Mask ventilation as required. 
 Place SGA or ETT. 
MAINTENANCE 
 
 TIVA + THRIVE (FiO2 1.0) at 70 l/min.  
 NBP q 5 min, unless indicated more frequently.  
 TIVA + O2:Air; FiO2 = 0.5 or higher as required 
 NBP q 5 min, unless indicated more frequently.  

STUDY PROTOCOL: THRIVE AND DIAGNOSTIC BRONCHOSCOPY  
 
 
 
 
 
Prepared by Vladimir Nekhendzy, M.D. 
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MAINTENANCE 
(cont.) 
 If SpO2 < 90%, or ventricular arrhythmias, discuss 
with surgeon converting to either SGA or ETT. 
 If surgical duration more than 30 min, consider 
converting to either SGA or ETT. 
 
 Mechanical ventilation to normocapnia: EtCO2 
35-40 mmHg. 
 Vt 6-8 ml/kg of predicted body weight (PBW), 
PEEP 5 cmH2O. 
 PBW Males = 50 + 2.3 (Height”- 60) 
 PBW Females = 45.5 + 2.3 (Height”- 60) 
 
 Sedline/BIS-guided TIVA with Propofol/Remifentanil to maintain PSI 25-50 (BIS 40-60).  
 Maintain main IV at TKO. All IV bolus drugs are chased by 15 ml of NS using in-line 20 ml syringe.  
 TIVA dosing: 
o TIVA is carried in by Alaris NS carrier at 50 ml/hr.  
o For normal weight patients, dose Prop/Remi infusions per total body weight. 
o For obese patients (BMI ≥ 30), dose Prop/Remi infusions per lean body weight (LBW). Simplified LBW 
formula: LBW = IBW x 1.2; IBW = 22 x Ht(m)2. 
o Propofol 80-150 mcg/kg/min, Remifentanil 0.05-0.3 mcg/kg/min. Optimize Remifentanil dose first. 
o Rocuronium boluses 0.15 mg/kg, to maintain 0-1/4 TOF at ulnar nerve. 
 Treating hypertensive responses (MAP > 20 mmHg from baseline): 
o Remifentanil 0.5 mcg/kg and Propofol 0.5 mg/kg boluses q 2 min, as required per hemodynamic 
responses and Sedline/BIS readings 
o Labetalol 0.07 mg/kg boluses q 10 min up to a total dose of 1 mg/kg, as required per hemodynamic 
responses and Sedline/BIS readings 
o Fentanyl 0.5 mcg/kg IV bolus, total dose limit 1 mcg/kg, only if perceived need for additional analgesia 
after Remifentanil had been maxed out at 0.3 mcg/kg 
 Treating hypotensive responses (MAP < 20 mmHg from baseline): 
o Crystalloid loading 5 ml/kg x 1 
o Ephedrine 5 mg IV if HR < 60 bpm, or Phenylephrine 100 mcg IV if HR > 60 bpm 

STUDY PROTOCOL: THRIVE AND DIAGNOSTIC BRONCHOSCOPY  
 
 
 
 
 
Prepared by Vladimir Nekhendzy, M.D. 
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o Vasopressin 1 unit IVP prn, as required 
o Phenylephrine drip, as required, start at 0.3 mcg/kg/min, increase in 50% increments 
EMERGENCE 
 
 
 
 
 
 Zofran 4 mg IV. 
 Reverse NMB with Suggamadex, as following: 2 mg/kg for TOF 1-2/4; 4 mg/kg for TOF 0/4, with postetanic 
count of 1-2.  
 Discontinue TIVA and disconnect TIVA line upon completion of surgery. 
 Transport to PACU: FMO2 at 6 l/min. 
 Maintain THRIVE at 70 l/min with jaw thrust ± oral 
airway as required, until return of spontaneous 
ventilation and consciousness. 
 Extubate per routine. 
 
STANDARDIZED 
POSTOP ORDERS 
 IV Fentanyl 25 mcg boluses q 5 min prn VAS ≥ 4, total dose 250 mcg. 
 PO Hydrocodone-acetaminophen (NORCO) 5-325 mg, 1 tab prn VAS ≥ 4, may repeat x 1. 
 If allergic to NORCO, Oxycodone-acetaminophen (PERCOCET) 5-325 mg, 1 tab prn VAS ≥ 4, may repeat x 1. 
 IV Demerol 10 mg for shivering only, may repeat x 1.  
 Treatment of PONV: 
o Zofran 8 mg IV x 1 
o If no effect, and no contraindications, add IV Promethazine 12.5 mg x 1 
PACU DATA 
COLLECTION 
 Obtain PACU data collection sheet and QoR15. 
 
QUESTIONNAIRES 
and DIARIES 
 Pre- and post-procedural QoR15 questionnaires and post-procedural home diaries will be given to the 
patients. The BMT patients will receive QoR15 questionnaires, but will not keep the home diaries.  

STUDY PROTOCOL: THRIVE AND DIAGNOSTIC BRONCHOSCOPY  
 
 
 
 
 
Prepared by Vladimir Nekhendzy, M.D. 
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THRIVE PROTOCOL 
PREOP 
 Randomize patient to THRIVE or ETT group. 
PREINDUCTION 
 Start THRIVE @ 30 l/min immediately, before applying other OR monitors.  
 Maintain patient’s head elevated 30-40°, with table in BACK UP, not reverse Trendelenburg position. 
INDUCTION 
 THRIVE @ 70 l/min. 
 Place an oral intubating airway and maintain a jaw thrust for introduction of the fiberoptic scope by surgeon.  
MAINTENANCE 
 Maintain THRIVE @ 70 l/min.  
 Maintain jaw thrust with the intubating oral airway in place for the duration of the procedure.  
 If surgery prolonged (over 30 min), consider converting to either SGA or ETT. 
 
EMERGENCE 
 Maintain THRIVE at 70 l/min with jaw thrust ± oral airway as required, until return of spontaneous ventilation 
and consciousness.