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THRIVE Use in Pediatric Populations- Multi Site

Primary Purpose

Oxygen Deficiency, Desaturation of Blood, Hypoventilation

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transnasal Humidified Rapid-Insufflation Ventilatory Echange

About this trial

This is an interventional prevention trial for Oxygen Deficiency

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Lucile Packard Children's Hospital Stanford
Lurie Children's Hospital of Chicago
Massachussetts Eye and Ear Harvard Medical School
Cincinnati Children's Hospital
The University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

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

Incidence of oxygen desaturation

Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second

Secondary Outcome Measures

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%

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

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

Full Information

NCT ID

NCT04322994

First Posted

March 21, 2020

Last Updated

June 15, 2023

Sponsor

Stanford University

Collaborators

Nationwide Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children's Hospital, UC Davis Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04322994

Brief Title

THRIVE Use in Pediatric Populations- Multi Site

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

October 21, 2020 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Nationwide Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children's Hospital, UC Davis Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transnasal Humidified Rapid-Insufflation Ventilatory Echange

Intervention Description

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

Primary Outcome Measure Information:

Title

Group differences in oxygen desaturation index

Description

Oxygen desaturation index is defined as a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds

Time Frame

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

Title

Relative incidence of desaturations <90% or defined by a 5% fall from baseline if baseline saturation < 94%.

Description

Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis

Time Frame

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

Title

Incidence of oxygen desaturation

Description

Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second

Time Frame

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

Secondary Outcome Measure Information:

Title

Duration and severity of desaturations <90%

Description

Duration and severity of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90%

Time Frame

Duration of surgery or procedure by second

Title

Relative number of surgical interruptions due to desaturation

Description

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

Time Frame

Duration of surgery or procedure

Title

Relative number and severity of airway interventions due to desaturation

Description

Number of Jaw thrust, bag mask ventilation, and/or endotracheal intubations due to desaturation, normalized by case length

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Gas pain or bloating

Description

Incidence of gas pain or bloating as measured by post-operative survey

Time Frame