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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04322994
Other study ID # 50881
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 21, 2020
Est. completion date July 2025

Study information

Verified date June 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 information / eligibility

Status Enrolling by invitation
Enrollment 500
Est. completion date July 2025
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Massachussetts Eye and Ear Harvard Medical School Boston Massachusetts
United States The University of Virginia Charlottesville Virginia
United States Lurie Children's Hospital of Chicago Chicago Illinois
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Lucile Packard Children's Hospital Stanford Palo Alto California

Sponsors (5)

Lead Sponsor Collaborator
Stanford University Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children's Hospital, Nationwide Children's Hospital, UC Davis Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other 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
Other 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 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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