Clinical trial NCT04322994: THRIVE Use in Pediatric Populations- Multi Site
Official title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Deficiency
Desaturation of Blood
Hypoventilation
Anesthesia; Adverse Effect
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Boston Children's Hospital
name: UC Davis Children's Hospital
First posted: 2020-03-26
Enrollment: 175
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With 4% Decrease From Baseline in Oxygen Desaturation Index
timeFrame: Duration of surgery or procedure, which is generally less than 2 hours
measure: Number of Participants With Desaturations <90%
timeFrame: Duration of surgery or procedure, which is generally less than 2 hours
measure: Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
timeFrame: Duration of surgery or procedure, which is generally less than 2 hours
Secondary outcomes:
measure: Time-normalized Area Under Curve (AUC) of Desaturations <90%
timeFrame: Duration of surgery or procedure, which is generally less than 2 hours
measure: Number of Participants With Surgical Interruptions Due to Desaturation
timeFrame: Duration of surgery or procedure, which is generally less than 2 hours
measure: Minimum Oxygen Saturation as a Measure of Desaturation Severity
timeFrame: Duration of surgery or procedure by second, which is generally less than 2 hours
Other outcomes:
measure: Gas Pain or Bloating
timeFrame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
measure: Nasal Irritation
timeFrame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
measure: Sinus Pressure / Pain
timeFrame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
measure: Headache
timeFrame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
measure: Other Adverse Events
timeFrame: Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Massachussetts Eye and Ear Harvard Medical School
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Charlottesville
country: United States
facility: The University of Virginia
state: Virginia
Study officials:
References: