Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures



Status:Recruiting
Healthy:No
Age Range:Any - 18
Updated:3/21/2019
Start Date:February 21, 2018
End Date:September 30, 2019
Contact:Thomas J Caruso, M.D., M.Ed.
Email:tjcaruso@stanford.edu
Phone:650-723-5728

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THRIVE (Transnasal Humidified Rapid-Insufflation Ventilatory Exchange) refers to the use of
high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under
general anesthesia. The use of high-flow nasal cannula oxygen supplementation during
anesthesia for surgical procedures has been a recent development in the adult population,
with limited data analyzing the pediatric population. This study will determine whether high
flow nasal cannula oxygen supplementation during surgical or endoscopic procedures can safely
prevent desaturation events in children under anesthesia.

Patients undergoing select procedures in the LPCH operating rooms or ambulatory procedure
unit, as identified by review of the daily schedule will be reviewed for potential study
enrollment. Study personnel will work with preoperative nurses to identify potential
participants. When potential candidates are identified, the investigators will discuss with
the surgeon or proceduralist and request that he/she talk with patients about study
participation to introduce the idea. On the day of surgery, potential subjects will arrive to
preoperative intake areas and proceed through the usual preoperative processes. Once in the
preoperative intake area, potential participants will be approached by study personnel at
least 30 minutes prior to their scheduled procedure for further explanation of the study and
obtaining consent and assent. At this time, potential subjects will be evaluated for interval
changes in health that may exclude them from the study. A random number generator will be
used to enroll participants into either the usual care (control) or THRIVE (treatment) arm.
Control subjects will undergo their scheduled procedure and recovery with the usual care.
Treatment subjects will undergo the scheduled procedure, with the difference being that a
high-flow nasal cannula will be applied prior to the start of the procedure and removed
following the procedure's conclusion. While applied, the cannula will deliver high- flow rate
oxygen, air, or a mixture of variable oxygen concentration (21-100%) depending on the
surgical conditions and requirements. The rate will be set at 1-2L/kg/min with a maximum of
70L/min. Participants in the treatment arm will then proceed to the recovery area as usual.
Following recovery from anesthesia, a brief questionnaire will be provided to applicable
patients or their parents/guardians/representatives. The intraoperative vital signs and
post-operative course will be analyzed with any patient data stored in a deidentified manner
on Stanford- compliant encrypted devices.

Inclusion Criteria:

- Pediatric patients less than or equal to 18 years old undergoing general anesthesia
for procedures or surgeries at Lucile Packard Children's Hospital.

Exclusion Criteria:

- Pregnancy, absence of parent or legal guardian able to provide written consent for
study participation, anatomical or surgical contraindications (epistaxis, basilar
skull fractures or abnormalities, nasal surgery or obstruction, nasal fractures, nasal
vascular abnormalities), pappillomatosis, trachestomy, emergent surgery for which
application of HFNC might delay surgery or might result in increased aspiration risk.
We found this trial at
1
site
450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Thomas J Caruso, M.D., M.Ed.
Phone: 650-723-5728
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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