An interventional study of High-flow nasal cannula in Oxygen Deficiency, Desaturation of Blood and Hypoventilation, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-08-06.
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 safely prevent desaturation events in children under anesthesia.
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's enrollment of 78 is above the median of 45 across 769 interventional studies indexed under Hypoxia.
Browse Hypoxia studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 1-2L/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.
Device: High-flow nasal cannula
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 2L/kg/min with a maximum of 70L/min. This will be only for the duration of the surgery or procedure.
Number of Surgical Interruptions
Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.
Time frame: Duration of surgery (generally less than 2 hours)
Oxygen Desaturation Index
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
Time frame: Duration of surgery (generally less than 2 hours)
Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%.
Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis
Time frame: Duration of surgery (generally less than 2 hours)
Incidence of Oxygen Desaturation
Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second
Time frame: Duration of surgery (generally less than 2 hours)
Incidence of Adverse Events
Time frame: Up to 12 hours
End-Tidal Carbon Dioxide (ETCO2)
Ventilation was measured with transcutaneous carbon dioxide sensor
Time frame: Duration of surgery (generally less than 2 hours)
Post-surgical Diagnosis
Location of lesion(s) according to post-surgical diagnosis
Time frame: Duration of surgery (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.
| Milestone | Standard of Care | THRIVE |
|---|---|---|
| Started | 40 | 38 |
| Completed | 18 | 21 |
| Not completed | 22 | 17 |
Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.
| Interruptions | Standard of Care | THRIVE |
|---|---|---|
| Number of Surgical Interruptions | 0.645 (0.308 to 1.35) | 0.302 (0.121 to 0.753) |
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
| Events | Standard of Care | THRIVE |
|---|---|---|
| Oxygen Desaturation Index | 1.09 (0.415 to 2.86) | 0.312 (0.100 to 0.976) |
Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis
| Events | Standard of Care | THRIVE |
|---|---|---|
| Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%. | 0.536 (0.195 to 1.473) | 0.268 (0.087 to 0.826) |
Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second
No measurements were reported for this outcome.
| Events | Standard of Care | THRIVE |
|---|---|---|
| Incidence of Adverse Events | 0.183 (0.061 to 0.547) | 0.268 (0.107 to 0.672) |
Ventilation was measured with transcutaneous carbon dioxide sensor
| mmHg | Standard of Care | THRIVE |
|---|---|---|
| End-Tidal Carbon Dioxide (ETCO2) | 51.6 (46.5 to 56.7) | 52.8 (48.2 to 57.4) |
Location of lesion(s) according to post-surgical diagnosis
| Participants | Standard of Care | THRIVE |
|---|---|---|
| Supraglottic | 2 | 10 |
| Infraglottic | 13 | 10 |
| Both Supraglottic and Infraglottic | 3 | 1 |
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 12 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/40 (0%) | 0/40 (0%) | 3/40 (7.5%) |
| THRIVE | 0/38 (0%) | 0/38 (0%) | 4/38 (10.5%) |
| Event | Standard of Care | THRIVE |
|---|---|---|
| NauseaGastrointestinal disorders | 2/40 | 2/38 |
| Throat PainRespiratory, thoracic and mediastinal disorders | 0/40 | 2/38 |
| Sinus PainRespiratory, thoracic and mediastinal disorders | 0/40 | 1/38 |
| Nose BleedingRespiratory, thoracic and mediastinal disorders | 0/40 | 1/38 |
| EmesisGastrointestinal disorders | 1/40 | 0/38 |
| Nasal PainRespiratory, thoracic and mediastinal disorders | 1/40 | 0/38 |
Participants who completed the protocol are included in the analysis
| Age, Continuous(years) | Standard of Care | THRIVE | Total |
|---|---|---|---|
| Mean | 5.1 ± 4.6 | 6.6 ± 6.2 | 5.5 ± 5.5 |
| Sex: Female, Male(Participants) | Standard of Care | THRIVE | Total |
|---|---|---|---|
| Female | 6 | 8 | 14 |
| Male | 12 | 13 | 25 |
| Race/Ethnicity, Customized(Participants) | Standard of Care | THRIVE | Total |
|---|---|---|---|
| White | 13 | 12 | 25 |
| Asian | 2 | 3 | 5 |
| Unknown/Unreported | 3 | 6 | 9 |
| Region of Enrollment(Participants) | Standard of Care | THRIVE | Total |
|---|---|---|---|
| United States | 18 | 21 | 39 |
| Percent Oxygen Saturation(Percent Saturation) | Standard of Care | THRIVE | Total |
|---|---|---|---|
| Mean | 99.7 ± 0.6 | 99.3 ± 1.5 | 99.5 ± 1.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — We are discussing with other facilities conducting research similar in description to or study for a possible multi-center study. If such coordination takes place, we anticipate all deidentified data collected with participating investigators.
Ran from Feb 2018 to primary completion in Oct 2018, 7 months.
Results were first posted in Aug 2020, 1 year 10 months after primary completion.
Of 321 non-industry interventional studies with no phase under Hypoxia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 7 months is below that.
Counting every sponsor, half of 351 studies reached it within 12 months; a quarter within 3 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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