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THRIVE Use in Pediatric Populations- Multi Site

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ClinicalTrials.gov Identifier: NCT04322994
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
University of Virginia
Massachusetts Eye and Ear Infirmary
University of California, Davis
University of Chicago
Information provided by (Responsible Party):
Thomas Caruso, Stanford University

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.

Condition or disease Intervention/treatment Phase
Oxygen Deficiency Desaturation of Blood Hypoventilation Anesthesia; Adverse Effect Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Populations: A Randomized Prospective Multi-Site Trial
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: Control
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.
Experimental: Intervention

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

Device: Transnasal Humidified Rapid-Insufflation Ventilatory Echange
The use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.




Primary Outcome Measures :
  1. Group differences in oxygen desaturation index [ Time Frame: Duration of surgery or procedure by second, 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

  2. Relative incidence of desaturations <90% or defined by a 5% fall from baseline if baseline saturation < 94%. [ 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

  3. Incidence of oxygen desaturation [ Time Frame: Duration of surgery or procedure by second, which is generally less than 2 hours ]
    Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second


Secondary Outcome Measures :
  1. Duration and severity of desaturations <90% [ Time Frame: Duration of surgery or procedure by second ]
    Duration and severity of oxygen desaturation less than 90% as measured by pulse oximetry by second by analyzing area under curve less than 90%

  2. Relative number of surgical interruptions due to desaturation [ Time Frame: Duration of surgery or procedure ]
    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

  3. Relative number and severity of airway interventions due to desaturation [ Time Frame: Duration of surgery or procedure by second, which is generally less than 2 hours ]
    Number of Jaw thrust, bag mask ventilation, and/or endotracheal intubations due to desaturation, normalized by case length


Other Outcome Measures:
  1. Gas pain or bloating [ Time Frame: 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

  2. Nasal irritation [ Time Frame: 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

  3. Sinus pressure / pain [ Time Frame: 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

  4. Headache [ Time Frame: 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

  5. Other adverse events [ Time Frame: 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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322994


Contacts
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Contact: Thomas Caruso, MD 6282750341 tjcaruso@stanford.edu
Contact: Ahtziri Foseca, BS 6282750341 afonseca@stanfordchildrens.org

Locations
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United States, California
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States, 94304
Contact: Thomas Caruso, MD    628-275-0341    tjcaruso@stanford.edu   
Contact: Ahtziri Fonseca, BS    6282750341    afonseca@stanfordchildrens.org   
United States, Illinois
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Contact: Michael Evans       mievans@luriechildrens.org   
United States, Massachusetts
Massachussetts Eye and Ear Harvard Medical School
Boston, Massachusetts, United States, 02114
Contact: Nita Sahani       nita_sahani@meei.harvard.edu   
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Contact: Vanessa Olbretch       vanessa.olbrecht@cchmc.org   
United States, Virginia
The University of Virginia
Charlottesville, Virginia, United States, 22903
Contact: Stephen Flynn       sgf5q@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
Stanford University
Children's Hospital Medical Center, Cincinnati
University of Virginia
Massachusetts Eye and Ear Infirmary
University of California, Davis
University of Chicago
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Responsible Party: Thomas Caruso, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04322994    
Other Study ID Numbers: 50881
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Hypoventilation
Hypoxia
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory