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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
| Boston Children's Hospital | OTHER |
| UC Davis Children's Hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Duration of surgery or procedure, which is generally less than 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Duration of surgery or procedure, which is generally less than 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Gas Pain or Bloating | Incidence of gas pain or bloating as measured by post-operative survey | Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively |
| Nasal Irritation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | 94304 | United States | ||
| Lurie Children's Hospital of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41485361 | Derived | Wang EY, Renuart AJ, Flynn SG, Van Pelt H, Devavaram P, Bulich LA, Stein ML, Ravula NR, Dhamrait RS, Kennedy KM, Suen MY, Jackson C, Gupta K, Swanger A, Yun R, Evans MA, Olbrecht VA, Caruso TJ. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) use in a pediatric population: A prospective, randomized controlled trial. J Clin Anesth. 2026 Feb;109:112117. doi: 10.1016/j.jclinane.2025.112117. Epub 2026 Jan 3. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants undergo their scheduled procedure and recovery with the usual care. |
| FG001 | High-flow Nasal Cannula | Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants undergo their scheduled procedure and recovery with the usual care. |
| BG001 | High-flow Nasal Cannula | Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who completed the protocol. | Posted | Count of Participants | Participants | Duration of surgery or procedure, which is generally less than 2 hours |
|
Up to 2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants undergo their scheduled procedure and recovery with the usual care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Thomas Caruso, MD, PhD | Stanford University | 6507235728 | tjcaruso@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2020 | Dec 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012131 | Respiratory Insufficiency |
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| UNKNOWN |
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| 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. | 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. | Duration of surgery or procedure by second, which is generally less than 2 hours |
Incidence of nasal irritation as measured by post-operative survey
| 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 | 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 | 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 | Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachussetts Eye and Ear Harvard Medical School | Boston | Massachusetts | 02114 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| The University of Virginia | Charlottesville | Virginia | 22903 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | Participants who completed the protocol. | Posted | Count of Participants | Participants | Duration of surgery or procedure, which is generally less than 2 hours |
|
|
|
|
| Primary | 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. | Participants who completed the protocol. | Posted | Count of Participants | Participants | Duration of surgery or procedure, which is generally less than 2 hours |
|
|
|
|
| Secondary | 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. | Participants who experienced desaturation less than 90% | Posted | Mean | Standard Error | % of blood oxygen saturation | Duration of surgery or procedure, which is generally less than 2 hours |
|
|
|
|
| Secondary | 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. | Participants who completed the protocol. | Posted | Count of Participants | Participants | Duration of surgery or procedure, which is generally less than 2 hours |
|
|
|
|
| Secondary | 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. | Participants who completed the protocol. | Posted | Count of Participants | Participants | Duration of surgery or procedure by second, which is generally less than 2 hours |
|
|
|
| Other Pre-specified | Gas Pain or Bloating | Incidence of gas pain or bloating as measured by post-operative survey | Not Posted | Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively | Participants |
| Other Pre-specified | Nasal Irritation | Incidence of nasal irritation as measured by post-operative survey | Not Posted | Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively | Participants |
| Other Pre-specified | Sinus Pressure / Pain | Incidence of sinus pressure and/or pain as measured by post-operative survey | Not Posted | Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively | Participants |
| Other Pre-specified | Headache | Incidence of headache as measured by post-operative survey | Not Posted | Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively | Participants |
| Other Pre-specified | Other Adverse Events | Other adverse events as measured by post-operative survey | Not Posted | Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively | Participants |
| 0 |
| 88 |
| 0 |
| 88 |
| 0 |
| 88 |
| EG001 | High-flow Nasal Cannula | Participants undergo their scheduled procedure, and also have a high-flow nasal cannula applied prior to the start of the procedure and removed following the procedure's conclusion. | 0 | 87 | 0 | 87 | 0 | 87 |
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| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| 2+ events |
|
Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events. |
| Chi-squared |
Chi-squared test of independence |
| 0.08 |
The a priori threshold for statistical significance was 0.05. |
| Other |
| 2+ events |
|
| Chi-squared |
| 0.38 |
The a priori threshold for statistical significance was 0.05. |
| Other |
| 2+ events |
|
Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions. |
| Chi-squared |
Chi-squared test of independence |
| 0.21 |
The a priori threshold for statistical significance was 0.05. |
| Other |
| 70-90% O2 saturation |
|
| 90-100% O2 saturation |
|