Anesthesia; Adverse Effect, Desaturation of Blood, Hypoventilation, Oxygen Deficiency
Conditions
Keywords
high-flow, nasal cannula, laryngoscopy, otolaryngology, oxygen, desaturation, anesthesia, pediatric
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 safely prevent desaturation events in children under anesthesia.
Detailed description
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.
Interventions
DEVICEHigh-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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients are randomized at time of enrollment to either the control or intervention arms.
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients less than or equal to 18 years old undergoing general anesthesia for procedures or surgeries at Lucile Packard Children's Hospital.
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), papillomatosis, tracheostomy, 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 Surgical Interruptions | Duration of surgery (generally less than 2 hours) | Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Desaturation Index | Duration of surgery (generally less than 2 hours) | 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 |
| Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%. | Duration of surgery (generally less than 2 hours) | Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis |
| Incidence of Oxygen Desaturation | Duration of surgery (generally less than 2 hours) | Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second |
| Incidence of Adverse Events | Up to 12 hours | — |
| End-Tidal Carbon Dioxide (ETCO2) | Duration of surgery (generally less than 2 hours) | Ventilation was measured with transcutaneous carbon dioxide sensor |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical Diagnosis | Duration of surgery (generally less than 2 hours) | Location of lesion(s) according to post-surgical diagnosis |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Control subjects will undergo their scheduled procedure and recovery with the usual standard care. | 18 |
| THRIVE Participants received high flow nasal oxygen (THRIVE: active nasal oxygen delivery system). | 21 |
| Total | 39 |
Baseline characteristics
| Characteristic | Total | THRIVE | Standard of Care |
|---|---|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 5.5 | 6.6 years STANDARD_DEVIATION 6.2 | 5.1 years STANDARD_DEVIATION 4.6 |
| Percent Oxygen Saturation | 99.5 Percent Saturation STANDARD_DEVIATION 1.2 | 99.3 Percent Saturation STANDARD_DEVIATION 1.5 | 99.7 Percent Saturation STANDARD_DEVIATION 0.6 |
| Race/Ethnicity, Customized Asian | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown/Unreported | 9 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 25 Participants | 12 Participants | 13 Participants |
| Region of Enrollment United States | 39 Participants | 21 Participants | 18 Participants |
| Sex: Female, Male Female | 14 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Male | 25 Participants | 13 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 38 |
| other Total, other adverse events | 3 / 40 | 4 / 38 |
| serious Total, serious adverse events | 0 / 40 | 0 / 38 |
Outcome results
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.
Time frame: Duration of surgery (generally less than 2 hours)
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Number of Surgical Interruptions | 0.645 Interruptions |
| THRIVE | Number of Surgical Interruptions | 0.302 Interruptions |
p-value: 0.206Regression, Negative Binomial
Secondary
End-Tidal Carbon Dioxide (ETCO2)
Ventilation was measured with transcutaneous carbon dioxide sensor
Time frame: Duration of surgery (generally less than 2 hours)
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | End-Tidal Carbon Dioxide (ETCO2) | 51.6 mmHg |
| THRIVE | End-Tidal Carbon Dioxide (ETCO2) | 52.8 mmHg |
p-value: 0.738Regression, Negative Binomial
Secondary
Incidence of Adverse Events
Time frame: Up to 12 hours
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Incidence of Adverse Events | 0.183 Events |
| THRIVE | Incidence of Adverse Events | 0.268 Events |
p-value: 0.601Regression, Negative Binomial
Secondary
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)
Population: This outcome measure was removed from the analysis plan during the course of the study.
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
Time frame: Duration of surgery (generally less than 2 hours)
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%. | 0.536 Events |
| THRIVE | Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%. | 0.268 Events |
p-value: 0.371Regression, Negative Binomial
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
Time frame: Duration of surgery (generally less than 2 hours)
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard of Care | Oxygen Desaturation Index | 1.09 Events |
| THRIVE | Oxygen Desaturation Index | 0.312 Events |
p-value: 0.101Regression, Negative Binomial
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
Post-surgical Diagnosis
Location of lesion(s) according to post-surgical diagnosis
Time frame: Duration of surgery (generally less than 2 hours)
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard of Care | Post-surgical Diagnosis | Supraglottic | 2 Participants |
| Standard of Care | Post-surgical Diagnosis | Infraglottic | 13 Participants |
| Standard of Care | Post-surgical Diagnosis | Both Supraglottic and Infraglottic | 3 Participants |
| THRIVE | Post-surgical Diagnosis | Supraglottic | 10 Participants |
| THRIVE | Post-surgical Diagnosis | Infraglottic | 10 Participants |
| THRIVE | Post-surgical Diagnosis | Both Supraglottic and Infraglottic | 1 Participants |
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.