Oxygen DeficiencyNCT04322994
THRIVE Use in Pediatric Populations- Multi Site
A study testing Transnasal Humidified Rapid-Insufflation Ventilatory Echange in people with Oxygen Deficiency and Desaturation of Blood, run by Stanford University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Deficiency, Desaturation of Blood, Hypoventilation
- What is being tested?
- Transnasal Humidified Rapid-Insufflation Ventilatory Echange
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Oct 2020to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachussetts Eye and Ear Harvard Medical School
Boston, Massachusetts, 02114
The University of Virginia
Charlottesville, Virginia, 22903
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial
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.
- Being tested
- Transnasal Humidified Rapid-Insufflation Ventilatory Echange
- Medical subject headings
- Hypoxia, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal Humidified Rapid-Insufflation Ventilatory EchangeDevice
The use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| 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 1-4L/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.
Intervention: Device: High-flow nasal cannula Receives: Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 4% Decrease From Baseline 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; data were recorded every 2 seconds while the procedure was being performed.
Measured: Duration of surgery or procedure, which is generally less than 2 hours
Number of Participants With Desaturations <90%
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.
Measured: Duration of surgery or procedure, which is generally less than 2 hours
Number of Participants Who Ever Either Fall Below 90% O2 or Drop 4% Below Baseline Saturation
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.
Measured: Duration of surgery or procedure, which is generally less than 2 hours
Secondary outcomes (3)
Time-normalized Area Under Curve (AUC) of Desaturations <90%
Duration of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90% (in those participants who experienced desaturation less than 90%), normalized as area under the curve / total time.
Measured: Duration of surgery or procedure, which is generally less than 2 hours
Number of Participants With Surgical Interruptions Due to Desaturation
Number of surgical interruptions due to desaturation defined by a pause in surgical procedures due to need to provide airway intervention to improve patient's oxygen saturation, normalized to case length. Airway interventions may include jaw thrust, bag mask ventilation, and/or endotracheal intubations.
Measured: Duration of surgery or procedure, which is generally less than 2 hours
Minimum Oxygen Saturation as a Measure of Desaturation Severity
Number of participants categorized by lowest oxygen saturation level during surgery (nadir). Lower saturation levels correspond to a lower level of oxygen in red blood cells.
Measured: Duration of surgery or procedure by second, which is generally less than 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start21 Oct 2020
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeficiencyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children's Hospital, UC Davis Children's Hospital
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322994
- Sponsor's protocol ID
- 50881
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2020
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wang EY, Renuart AJ, Flynn SG, Van Pelt H, Devavaram P, Bulich LA, Stein ML, Ravula NR, Dhamrait RS, Kennedy KM, Suen MY, Jackson C, Gupta K, Swanger A, Yun R, Evans MA, Olbrecht VA, Caruso TJ. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) use in a pediatric population: A prospective, randomized controlled trial. J Clin Anesth. 2026 Feb;109:112117. doi: 10.1016/j.jclinane.2025.112117. Epub 2026 Jan 3.
PubMed 41485361
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial
- ClinicalTrials.gov ID
- NCT04322994
- Acronym / sponsor ID
- 50881
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Boston Children's Hospital, UC Davis Children's Hospital
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Transnasal Humidified Rapid-Insufflation Ventilatory EchangeTreatment 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 1-4L/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. Intervention: Device: High-flow nasal cannula |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients less than 18 years of age undergoing general anesthesia for procedures or surgeries
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal Humidified Rapid-Insufflation Ventilatory EchangeThe use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia. | Device | Intervention |
Primary outcome
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.
3 secondary outcomes
Time-normalized Area Under Curve (AUC) of Desaturations <90%
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Number of Participants With Surgical Interruptions Due to Desaturation
Time frame: Duration of surgery or procedure, which is generally less than 2 hours
Minimum Oxygen Saturation as a Measure of Desaturation Severity
Time frame: Duration of surgery or procedure by second, which is generally less than 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41485361Wang EY, Renuart AJ, Flynn SG, Van Pelt H, Devavaram P, Bulich LA, Stein ML, Ravula NR, Dhamrait RS, Kennedy KM, Suen MY, Jackson C, Gupta K, Swanger A, Yun R, Evans MA, Olbrecht VA, Caruso TJ. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) use in a pediatric population: A prospective, randomized controlled trial. J Clin Anesth. 2026 Feb;109:112117. doi: 10.1016/j.jclinane.2025.112117. Epub 2026 Jan 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal Humidified Rapid-Insufflation Ventilatory Echange in people with Oxygen Deficiency and Desaturation of Blood, run by Stanford University at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.