Anesthesia; Adverse Effect Clinical Trial
Official title:
Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial
Verified date | June 2023 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 500 |
Est. completion date | July 2025 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachussetts Eye and Ear Harvard Medical School | Boston | Massachusetts |
United States | The University of Virginia | Charlottesville | Virginia |
United States | Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
United States | Lucile Packard Children's Hospital Stanford | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children's Hospital, Nationwide Children's Hospital, UC Davis Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | 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 | |
Primary | Group differences 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 | Duration of surgery or procedure by second, which is generally less than 2 hours | |
Primary | Relative incidence of desaturations <90% or defined by a 5% fall from baseline if baseline saturation < 94%. | Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second adjusted for post surgical diagnosis | Duration of surgery or procedure, which is generally less than 2 hours | |
Primary | Incidence of oxygen desaturation | Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second | Duration of surgery or procedure by second, which is generally less than 2 hours | |
Secondary | Duration and severity of desaturations <90% | Duration and severity of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% | Duration of surgery or procedure by second | |
Secondary | Relative number of surgical interruptions due to desaturation | Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to intervene to improve patient's oxygen saturation, normalized to case length | Duration of surgery or procedure | |
Secondary | Relative number and severity of airway interventions due to desaturation | Number of Jaw thrust, bag mask ventilation, and/or endotracheal intubations due to desaturation, normalized by case length | Duration of surgery or procedure by second, which is generally less than 2 hours |
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