THRIVE Use in Pediatric Populations- Multi Site

Not Applicable

Completed

Conditions: Hypoventilation
Anesthesia; Adverse Effect
Desaturation of Blood
Oxygen Deficiency

Interventions: Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Intervention	Transnasal Humidified Rapid-Insufflation Ventilatory Echange	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index	Duration of surgery or procedure, which is generally less than 2 hours	Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds; data were recorded every 2 seconds while the procedure was being performed.
Number of Participants With Desaturations <90%	Duration of surgery or procedure, which is generally less than 2 hours	Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed.
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation	Duration of surgery or procedure, which is generally less than 2 hours	Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis; data were recorded every 2 seconds while the procedure was being performed. Participants who experienced both a fall below 90% O2 and a 4% drop below baseline saturation are reported as having more than 1 event.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Interruptions Due to Desaturation	Duration of surgery or procedure, which is generally less than 2 hours	Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to provide airway intervention to improve patient's oxygen saturation, normalized to case length. Airway interventions may include jaw thrust, bag mask ventilation, and/or endotracheal intubations.
Time-normalized Area Under Curve (AUC) of Desaturations <90%	Duration of surgery or procedure, which is generally less than 2 hours	Duration of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% (in those participants who experienced desaturation less than 90%), normalized as area under the curve / total time.
Minimum Oxygen Saturation as a Measure of Desaturation Severity	Duration of surgery or procedure by second, which is generally less than 2 hours	Number of participants categorized by lowest oxygen saturation level during surgery (nadir). Lower saturation levels correspond to a lower level of oxygen in red blood cells.

Locations (5): Lucile Packard Children's Hospital Stanford
🇺🇸
Palo Alto, California, United States
The University of Virginia
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Charlottesville, Virginia, United States
Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States
Massachussetts Eye and Ear Harvard Medical School
🇺🇸
Boston, Massachusetts, United States
Cincinnati Children's Hospital
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Cincinnati, Ohio, United States