THRIVE Use in Pediatric Populations- Multi Site

Stanford University

Status: Completed

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

Treatments: Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange

Study type: Interventional

Funder types: Other

Identifiers

NCT04322994

50881

Details and patient eligibility

About

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.

Enrollment: 175 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 2 patient groups

Control

No Intervention group

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.

Intervention

Experimental group

Description:

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

Treatment:

Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange