THRIVE Use in Pediatric Populations- Multi Site

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2024-01-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Oxygen Deficiency Desaturation of Blood Hypoventilation Anesthesia; Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Transnasal Humidified Rapid-Insufflation Ventilatory Echange

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes