Anesthesia; Adverse Effect, Desaturation of Blood, Hypoventilation, Oxygen Deficiency
Conditions
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 prevent desaturation events in children under anesthesia and improve the outcomes of that surgery.
Interventions
DEVICETransnasal 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.
Sponsors
Nationwide Children's Hospital
Ann & Robert H Lurie Children's Hospital of Chicago
Boston Children's Hospital
UC Davis Children's Hospital
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index | 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. |
| Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation | 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. |
| Number of Participants With Desaturations <90% | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-normalized Area Under Curve (AUC) of Desaturations <90% | 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. |
| Number of Participants With Surgical Interruptions Due to Desaturation | 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. |
| Minimum Oxygen Saturation as a Measure of Desaturation Severity | 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
| Measure | Time frame | Description |
|---|---|---|
| Sinus Pressure / Pain | 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 |
| Nasal Irritation | 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 |
| Headache | 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 |
| Other Adverse Events | 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 |
| Gas Pain or Bloating | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Participants undergo their scheduled procedure and recovery with the usual care. | 71 |
| 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. | 73 |
| Total | 144 |
Baseline characteristics
| Characteristic | Control | High-flow Nasal Cannula | Total |
|---|---|---|---|
| Age, Continuous | 5.6 years STANDARD_DEVIATION 5.2 | 4.7 years STANDARD_DEVIATION 5.1 | 5.1 years STANDARD_DEVIATION 5.1 |
| Race/Ethnicity, Customized Asian | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 13 Participants | 18 Participants | 31 Participants |
| Race/Ethnicity, Customized Missing | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Multirace | 2 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 44 Participants | 43 Participants | 87 Participants |
| Region of Enrollment United States | 71 Participants | 73 Participants | 144 Participants |
| Sex: Female, Male Female | 28 Participants | 20 Participants | 48 Participants |
| Sex: Female, Male Male | 43 Participants | 53 Participants | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 0 / 87 |
| other Total, other adverse events | 0 / 88 | 0 / 87 |
| serious Total, serious adverse events | 0 / 88 | 0 / 87 |
Outcome results
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Population: Participants who completed the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation | Any event | 19 Participants |
| Control | Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation | 1 event | 3 Participants |
| Control | Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation | 2+ events | 16 Participants |
| High-flow Nasal Cannula | Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation | Any event | 13 Participants |
| High-flow Nasal Cannula | Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation | 1 event | 3 Participants |
| High-flow Nasal Cannula | Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation | 2+ events | 10 Participants |
Comparison: Analysis of between-group difference for participants with any qualifying event.p-value: 0.28Chi-squared
Comparison: Analysis of between-group difference for participants with 1 qualifying event versus 2 or more events.p-value: 0.38Chi-squared
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Population: Participants who completed the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index | Any event | 18 Participants |
| Control | Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index | 1 event | 13 Participants |
| Control | Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index | 2+ events | 5 Participants |
| High-flow Nasal Cannula | Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index | Any event | 11 Participants |
| High-flow Nasal Cannula | Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index | 1 event | 9 Participants |
| High-flow Nasal Cannula | Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index | 2+ events | 2 Participants |
Comparison: Analysis of between-group difference for participants with any desaturation event.p-value: 0.18Chi-squared
Comparison: Analysis of between-group difference for participants with 1 desaturation event versus 2 or more events.p-value: 0.26Chi-squared
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Population: Participants who completed the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Desaturations <90% | Any event | 17 Participants |
| Control | Number of Participants With Desaturations <90% | 1 event | 8 Participants |
| Control | Number of Participants With Desaturations <90% | 2+ events | 9 Participants |
| High-flow Nasal Cannula | Number of Participants With Desaturations <90% | Any event | 11 Participants |
| High-flow Nasal Cannula | Number of Participants With Desaturations <90% | 1 event | 9 Participants |
| High-flow Nasal Cannula | Number of Participants With Desaturations <90% | 2+ events | 2 Participants |
Comparison: Analysis of between-group difference for participants with at any qualifying desaturation event.p-value: 0.26Chi-squared
Comparison: Analysis of between-group difference for participants with 1 qualifying desaturation event versus 2 or more qualifying events.p-value: 0.08Chi-squared
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.
Time frame: Duration of surgery or procedure by second, which is generally less than 2 hours
Population: Participants who completed the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 0-50% O2 saturation | 2 Participants |
| Control | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 50-70% O2 saturation | 3 Participants |
| Control | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 70-90% O2 saturation | 12 Participants |
| Control | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 90-100% O2 saturation | 54 Participants |
| High-flow Nasal Cannula | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 90-100% O2 saturation | 62 Participants |
| High-flow Nasal Cannula | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 0-50% O2 saturation | 2 Participants |
| High-flow Nasal Cannula | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 70-90% O2 saturation | 7 Participants |
| High-flow Nasal Cannula | Minimum Oxygen Saturation as a Measure of Desaturation Severity | 50-70% O2 saturation | 2 Participants |
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Population: Participants who completed the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Number of Participants With Surgical Interruptions Due to Desaturation | Any event | 14 Participants |
| Control | Number of Participants With Surgical Interruptions Due to Desaturation | 1 event | 11 Participants |
| Control | Number of Participants With Surgical Interruptions Due to Desaturation | 2+ events | 3 Participants |
| High-flow Nasal Cannula | Number of Participants With Surgical Interruptions Due to Desaturation | Any event | 7 Participants |
| High-flow Nasal Cannula | Number of Participants With Surgical Interruptions Due to Desaturation | 1 event | 5 Participants |
| High-flow Nasal Cannula | Number of Participants With Surgical Interruptions Due to Desaturation | 2+ events | 2 Participants |
Comparison: Analysis of between-group difference for participants with any surgical interruption.p-value: 0.14Chi-squared, Corrected
Comparison: Analysis of between-group difference for participants with 1 surgical interruption versus 2 or more interruptions.p-value: 0.21Chi-squared
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.
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Population: Participants who experienced desaturation less than 90%
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Time-normalized Area Under Curve (AUC) of Desaturations <90% | 0.3 % of blood oxygen saturation | Standard Error 0.91 |
| High-flow Nasal Cannula | Time-normalized Area Under Curve (AUC) of Desaturations <90% | 0.28 % of blood oxygen saturation | Standard Error 1.19 |
Comparison: Analysis of between-group difference for participants with at any qualifying desaturation event.p-value: 0.88t-test, 2 sided
Other Pre-specified
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
Other Pre-specified
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 Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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