An interventional study of Transnasal Humidified Rapid-Insufflation Ventilatory Echange in Oxygen Deficiency, Desaturation of Blood and Hypoventilation, sponsored by Stanford University. Completed at 5 sites in United States. Open to participants aged Up to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
Exclusion Criteria:
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
Device: 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.
Number of Participants With 4% Decrease From Baseline 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; data were recorded every 2 seconds while the procedure was being performed.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Number of Participants With Desaturations <90%
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Time-normalized Area Under Curve (AUC) of Desaturations <90%
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Number of Participants With Surgical Interruptions Due to Desaturation
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Minimum Oxygen Saturation as a Measure of Desaturation Severity
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.
Time frame: Duration of surgery or procedure by second, which is generally less than 2 hours
Gas Pain or Bloating
Incidence of gas pain or bloating as measured by post-operative survey
Time frame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Nasal Irritation
Incidence of nasal irritation as measured by post-operative survey
Time frame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Sinus Pressure / Pain
Incidence of sinus pressure and/or pain as measured by post-operative survey
Time frame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Headache
Incidence of headache as measured by post-operative survey
Time frame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Other Adverse Events
Other adverse events as measured by post-operative survey
Time frame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Participants were recruited from six pediatric sites (Lucile Packard Children's Hospital, Cincinnati Children's hospital, Lurie Children's Hospital, University of Virginia Children's Hospital, Massachusetts Eye and Ear Infirmary, and Boston Children's Hospital between October 2020 and January 2024. The first participant was enrolled on October 21, 2020 and the last participant was enrolled in January 19, 2024.
| Milestone | Control | High-flow Nasal Cannula |
|---|---|---|
| Started | 88 | 87 |
| Completed | 71 | 73 |
| Not completed | 17 | 14 |
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.
| Participants | Control | High-flow Nasal Cannula |
|---|---|---|
| Any event | 18 | 11 |
| 1 event | 13 | 9 |
| 2+ events | 5 | 2 |
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 | Control | High-flow Nasal Cannula |
|---|---|---|
| Any event | 17 | 11 |
| 1 event | 8 | 9 |
| 2+ events | 9 | 2 |
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.
| Participants | Control | High-flow Nasal Cannula |
|---|---|---|
| Any event | 19 | 13 |
| 1 event | 3 | 3 |
| 2+ events | 16 | 10 |
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.
| % of blood oxygen saturation | Control | High-flow Nasal Cannula |
|---|---|---|
| Time-normalized Area Under Curve (AUC) of Desaturations <90% | 0.3 ± 0.91 | 0.28 ± 1.19 |
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.
| Participants | Control | High-flow Nasal Cannula |
|---|---|---|
| Any event | 14 | 7 |
| 1 event | 11 | 5 |
| 2+ events | 3 | 2 |
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.
| Participants | Control | High-flow Nasal Cannula |
|---|---|---|
| 0-50% O2 saturation | 2 | 2 |
| 50-70% O2 saturation | 3 | 2 |
| 70-90% O2 saturation | 12 | 7 |
| 90-100% O2 saturation | 54 | 62 |
Incidence of gas pain or bloating as measured by post-operative survey
Results for this outcome have not been posted.
Incidence of nasal irritation as measured by post-operative survey
Results for this outcome have not been posted.
Incidence of sinus pressure and/or pain as measured by post-operative survey
Results for this outcome have not been posted.
Incidence of headache as measured by post-operative survey
Results for this outcome have not been posted.
Other adverse events as measured by post-operative survey
Results for this outcome have not been posted.
Collected over Up to 2 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/88 (0%) | 0/88 (0%) | 0/88 (0%) |
| High-flow Nasal Cannula | 0/87 (0%) | 0/87 (0%) | 0/87 (0%) |
Participants who completed the protocol.
| Age, Continuous(years) | Control | High-flow Nasal Cannula | Total |
|---|---|---|---|
| Mean | 5.6 ± 5.2 | 4.7 ± 5.1 | 5.1 ± 5.1 |
| Sex: Female, Male(Participants) | Control | High-flow Nasal Cannula | Total |
|---|---|---|---|
| Female | 28 | 20 | 48 |
| Male | 43 | 53 | 96 |
| Race/Ethnicity, Customized(Participants) | Control | High-flow Nasal Cannula | Total |
|---|---|---|---|
| White | 44 | 43 | 87 |
| Black | 1 | 2 | 3 |
| Hispanic | 13 | 18 | 31 |
| Asian | 5 | 2 | 7 |
| Multirace | 2 | 4 | 6 |
| Missing | 6 | 4 | 10 |
| Region of Enrollment(Participants) | Control | High-flow Nasal Cannula | Total |
|---|---|---|---|
| United States | 71 | 73 | 144 |
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