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Completed

NCT Number: NCT04322994

THRIVE Use in Pediatric Populations- Multi Site

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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Key information

Conditions

Oxygen Deficiency Anesthesia; Adverse Effect Desaturation of Blood Hypoventilation Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index

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

    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.

  2. Number of Participants With Desaturations <90%

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

    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.

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

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

    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.

Secondary outcomes

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

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

    Duration of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% (in those participants who experienced desaturation less than 90%), normalized as area under the curve / total time.

  2. Number of Participants With Surgical Interruptions Due to Desaturation

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

    Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to provide airway intervention to improve patient's oxygen saturation, normalized to case length. Airway interventions may include jaw thrust, bag mask ventilation, and/or endotracheal intubations.

  3. Minimum Oxygen Saturation as a Measure of Desaturation Severity

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

    Number of participants categorized by lowest oxygen saturation level during surgery (nadir). Lower saturation levels correspond to a lower level of oxygen in red blood cells.

Other outcomes

  1. Gas Pain or Bloating

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

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

  2. Nasal Irritation

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

    Incidence of nasal irritation as measured by post-operative survey

  3. Sinus Pressure / Pain

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

    Incidence of sinus pressure and/or pain as measured by post-operative survey

  4. Headache

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

    Incidence of headache as measured by post-operative survey

  5. Other Adverse Events

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

    Other adverse events as measured by post-operative survey

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2020
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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