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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 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.
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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 1-2L/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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal cannula | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Surgical Interruptions | Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length. | Duration of surgery (generally less than 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-surgical Diagnosis | Location of lesion(s) according to post-surgical diagnosis | Duration of surgery (generally less than 2 hours) |
| Gas Pain or Bloating | Incidence of gas pain or bloating as measured by post-operative survey |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas J Caruso, M.D., M.Ed. | Associate Clinical Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28393433 | Background | Humphreys S, Rosen D, Housden T, Taylor J, Schibler A. Nasal high-flow oxygen delivery in children with abnormal airways. Paediatr Anaesth. 2017 Jun;27(6):616-620. doi: 10.1111/pan.13151. Epub 2017 Apr 10. | |
| 27546740 | Background | Doyle AJ, Stolady D, Mariyaselvam M, Wijewardena G, Gent E, Blunt M, Young P. Preoxygenation and apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for emergency intubation. J Crit Care. 2016 Dec;36:8-12. doi: 10.1016/j.jcrc.2016.06.011. Epub 2016 Jun 23. |
| Label | URL |
|---|---|
| Anticipated Australian study of similar protocol | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Control subjects will undergo their scheduled procedure and recovery with the usual standard care. |
| FG001 | THRIVE | Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the protocol are included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Control subjects will undergo their scheduled procedure and recovery with the usual standard care. |
| BG001 | THRIVE | Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). |
| 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 Surgical Interruptions | Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length. | Participants who completed the protocol are included in the analysis | Posted | Mean | 95% Confidence Interval | Interruptions | Duration of surgery (generally less than 2 hours) |
|
Up to 12 hours
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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 | Standard of Care | Control subjects will undergo their scheduled procedure and recovery with the usual standard care. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Enrollment did not meet the threshold needed for statistical significance
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Caruso, MD, MEd | Stanford University | (626) 275-0341 | 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 | Yes | No | No | Study Protocol | Jan 9, 2018 | Jul 9, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 9, 2020 | Jul 15, 2020 | SAP_001.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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Patients are randomized at time of enrollment to either the control or intervention arms.
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|
Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis |
| 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 | Duration of surgery (generally less than 2 hours) |
| Incidence of Adverse Events | Up to 12 hours |
| End-Tidal Carbon Dioxide (ETCO2) | Ventilation was measured with transcutaneous carbon dioxide sensor | Duration of surgery (generally less than 2 hours) |
| 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 | 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. |
| 28035669 | Background | Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30. |
| 28100527 | Background | Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401. |
| 28403407 | Background | Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036. |
| 28622152 | Background | Desai N, Fowler A. Use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Emergent Surgical Tracheostomy: A Case Report. A A Case Rep. 2017 Nov 1;9(9):268-270. doi: 10.1213/XAA.0000000000000589. |
| 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 |
|
| Percent Oxygen Saturation | 3 participants in the THRIVE group were missing baseline values | Mean | Standard Deviation | Percent Saturation |
|
|
|
|
| Secondary | 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 | Participants who completed the protocol are included in the analysis | Posted | Mean | 95% Confidence Interval | Events | Duration of surgery (generally less than 2 hours) |
|
|
|
|
| Secondary | 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 | Participants who completed the protocol are included in the analysis | Posted | Mean | 95% Confidence Interval | Events | Duration of surgery (generally less than 2 hours) |
|
|
|
|
| Secondary | Incidence of Oxygen Desaturation | Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second | This outcome measure was removed from the analysis plan during the course of the study. | Posted | Duration of surgery (generally less than 2 hours) |
|
|
| Secondary | Incidence of Adverse Events | Participants who completed the protocol are included in the analysis | Posted | Mean | 95% Confidence Interval | Events | Up to 12 hours |
|
|
|
|
| Secondary | End-Tidal Carbon Dioxide (ETCO2) | Ventilation was measured with transcutaneous carbon dioxide sensor | Participants who completed the protocol are included in the analysis | Posted | Mean | 95% Confidence Interval | mmHg | Duration of surgery (generally less than 2 hours) |
|
|
|
|
| Other Pre-specified | Post-surgical Diagnosis | Location of lesion(s) according to post-surgical diagnosis | Participants who completed the protocol are included in the analysis | Posted | Count of Participants | Participants | Duration of surgery (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 |
| 40 |
| 0 |
| 40 |
| 3 |
| 40 |
| EG001 | THRIVE | Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). | 0 | 38 | 0 | 38 | 4 | 38 |
| Sinus Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nose Bleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Emesis | Gastrointestinal disorders | Systematic Assessment |
|
| Throat Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Unconfirmed |
|
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| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| Both Supraglottic and Infraglottic |
|