THRIVE Use in Pediatric Populations- Multi Site

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Oxygen Deficiency; Hypoventilation; Desaturation of Blood; Anesthesia; Adverse Effect
• Intervention / Treatment: Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital Stanford
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital of Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachussetts Eye and Ear Harvard Medical School
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati CHildren's Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • The University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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; 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; The use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gas pain or bloating	Incidence of gas pain or bloating as measured by post-operative survey	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Nasal irritation	Incidence of nasal irritation as measured by post-operative survey	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Sinus pressure / pain	Incidence of sinus pressure and/or pain as measured by post-operative survey	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Headache	Incidence of headache as measured by post-operative survey	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Other adverse events	Other adverse events as measured by post-operative survey	Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Boston Children's Hospital; Ann & Robert H Lurie Children's Hospital of Chicago; Nationwide Children's Hospital; UC Davis Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: March 21, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia; Hypoventilation
• Other Study ID Numbers: 50881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes