THRIVE Use in Pediatric Populations- Multi Site

Anesthesia; Adverse Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04322994
• Other study ID #: 50881
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Desaturation of Blood
• Hypoventilation
• Hypoxia
• Oxygen Deficiency

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