Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 175
- Locations
- 10
- Primary Endpoint
- Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
Time Frame: 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 With Desaturations <90%
Time Frame: 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.
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
Time Frame: 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.
Secondary Outcomes
- Number of Participants With Surgical Interruptions Due to Desaturation(Duration of surgery or procedure, which is generally less than 2 hours)
- Time-normalized Area Under Curve (AUC) of Desaturations <90%(Duration of surgery or procedure, which is generally less than 2 hours)
- Minimum Oxygen Saturation as a Measure of Desaturation Severity(Duration of surgery or procedure by second, which is generally less than 2 hours)
Investigators
Thomas Caruso
Clinical Associate Professor
Stanford University