THRIVE Use in Pediatric Populations- Multi Site

NCT04322994 | Completed Results FDA Device

• 1 other identifier: 50881
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants With 4% Decrease From Baseline 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; data were recorded every 2 seconds while the procedure was being performed.

  Duration of surgery or procedure, which is generally less than 2 hours

• Number of Participants With Desaturations <90%

  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.

  Duration of surgery or procedure, which is generally less than 2 hours

• Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation

  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.

  Duration of surgery or procedure, which is generally less than 2 hours

Secondary Outcomes (3)

• Time-normalized Area Under Curve (AUC) of Desaturations <90%

  Duration of surgery or procedure, which is generally less than 2 hours

• Number of Participants With Surgical Interruptions Due to Desaturation

  Duration of surgery or procedure, which is generally less than 2 hours

• Minimum Oxygen Saturation as a Measure of Desaturation Severity

  Duration of surgery or procedure by second, which is generally less than 2 hours

Other Outcomes (5)

• Gas Pain or Bloating

  Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively

• Nasal Irritation

  Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively

• Sinus Pressure / Pain

  Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Transnasal Humidified Rapid-Insufflation Ventilatory Echange DEVICE

The use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.

Intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Nationwide Children's Hospital: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Boston Children's Hospital: collaborator
• UC Davis Children's Hospital: collaborator

Study Sites (5)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Massachussetts Eye and Ear Harvard Medical School

Boston, Massachusetts, 02114, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

The University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Hypoxia; Hypoventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Thomas Caruso, MD, PhD
• Organization: Stanford University

tjcaruso@stanford.edu

6507235728

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: March 26, 2020
• Study Start: October 21, 2020
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: March 27, 2025
• Results First Posted: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)