Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures

Not Applicable

Completed

• Conditions: Oxygen Deficiency; Desaturation of Blood; Hypoventilation; Anesthesia; Adverse Effect
• Interventions: Device: High-flow nasal cannula

• Registration Number: NCT03430206
• Lead Sponsor: Stanford University

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 safely prevent desaturation events in children under anesthesia.

Detailed Description

Patients undergoing select procedures in the LPCH operating rooms or ambulatory procedure unit, as identified by review of the daily schedule will be reviewed for potential study enrollment. Study personnel will work with preoperative nurses to identify potential participants. When potential candidates are identified, the investigators will discuss with the surgeon or proceduralist and request that he/she talk with patients about study participation to introduce the idea. On the day of surgery, potential subjects will arrive to preoperative intake areas and proceed through the usual preoperative processes. Once in the preoperative intake area, potential participants will be approached by study personnel at least 30 minutes prior to their scheduled procedure for further explanation of the study and obtaining consent and assent. At this time, potential subjects will be evaluated for interval changes in health that may exclude them from the study. A random number generator will be used to enroll participants into either the usual care (control) or THRIVE (treatment) arm. Control subjects will undergo their scheduled procedure and recovery with the usual care. 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 1-2L/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. The intraoperative vital signs and post-operative course will be analyzed with any patient data stored in a deidentified manner on Stanford- compliant encrypted devices.

Study Timeline

• Study First Submitted: 2018-01-20
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Study Start: 2018-02-21
• Primary Completion: 2018-10-02
• Study Completion: 2018-10-02
• Results First Submitted: 2020-07-16
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-03
• Last Update Submitted: 2020-08-03
• Results First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Pediatric patients less than or equal to 18 years old undergoing general anesthesia for procedures or surgeries at Lucile Packard Children's Hospital.

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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), papillomatosis, tracheostomy, emergent surgery for which application of HFNC might delay surgery or might result in increased aspiration risk.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	High-flow nasal cannula	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 1-2L/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.

Primary Outcome Measures

Name	Time	Method
Number of Surgical Interruptions	Duration of surgery (generally less than 2 hours)	Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.

Secondary Outcome Measures

Name	Time	Method
End-Tidal Carbon Dioxide (ETCO2)	Duration of surgery (generally less than 2 hours)	Ventilation was measured with transcutaneous carbon dioxide sensor
Oxygen Desaturation Index	Duration of surgery (generally less than 2 hours)	Oxygen desaturation index is defined as the number of times a patient has a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds
Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%.	Duration of surgery (generally less than 2 hours)	Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis
Incidence of Adverse Events	Up to 12 hours
Incidence of Oxygen Desaturation	Duration of surgery (generally less than 2 hours)	Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States