THRIVE Use in Pediatric Populations- Multi Site

Study Overview
=================
Brief Summary
-----------------
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 prevent desaturation events in children under anesthesia and improve the outcomes of that surgery.

Official Title
-----------------
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial

Conditions
-----------------
Oxygen Deficiency, Desaturation of Blood, Hypoventilation, Anesthesia; Adverse Effect

Intervention / Treatment
-----------------
* Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries 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), tracheostomy tube Emergent surgery for which application of HFNC might delay surgery or might result in increased aspiration risk.

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Control subjects will undergo their scheduled procedure and recovery with the usual care. Following recovery from anesthesia, a brief questionnaire will be provided to applicable patients or their parents / guardians / representatives. | |
| Experimental: Intervention<br>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 1-4L/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. Intervention: Device: High-flow nasal cannula | Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange<br>* The use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group differences in oxygen desaturation index | Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds | Duration of surgery or procedure by second, which is generally less than 2 hours | 
| Relative incidence of desaturations <90% or defined by a 5% fall from baseline if baseline saturation < 94%. | Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis | Duration of surgery or procedure, which is generally less than 2 hours | 
| Incidence of oxygen desaturation | Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second | Duration of surgery or procedure by second, which is generally less than 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration and severity of desaturations <90% | Duration and severity of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% | Duration of surgery or procedure by second | 
| Relative number of surgical interruptions due to desaturation | Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to intervene to improve patient's oxygen saturation, normalized to case length | Duration of surgery or procedure | 
| Relative number and severity of airway interventions due to desaturation | Number of Jaw thrust, bag mask ventilation, and/or endotracheal intubations due to desaturation, normalized by case length | Duration of surgery or procedure by second, which is generally less than 2 hours |