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Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures

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ClinicalTrials.gov Identifier: NCT03430206
Recruitment Status : Completed
First Posted : February 12, 2018
Results First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
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 safely prevent desaturation events in children under anesthesia.

Condition or disease Intervention/treatment Phase
Oxygen Deficiency Desaturation of Blood Hypoventilation Anesthesia; Adverse Effect Device: High-flow nasal cannula Not Applicable

Detailed Description:
Patients undergoing select procedures in the LPCH operating rooms or ambulatory procedure unit, as identified by review of the daily schedule will be reviewed for potential study enrollment. Study personnel will work with preoperative nurses to identify potential participants. When potential candidates are identified, the investigators will discuss with the surgeon or proceduralist and request that he/she talk with patients about study participation to introduce the idea. On the day of surgery, potential subjects will arrive to preoperative intake areas and proceed through the usual preoperative processes. Once in the preoperative intake area, potential participants will be approached by study personnel at least 30 minutes prior to their scheduled procedure for further explanation of the study and obtaining consent and assent. At this time, potential subjects will be evaluated for interval changes in health that may exclude them from the study. A random number generator will be used to enroll participants into either the usual care (control) or THRIVE (treatment) arm. Control subjects will undergo their scheduled procedure and recovery with the usual care. 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 1-2L/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. The intraoperative vital signs and post-operative course will be analyzed with any patient data stored in a deidentified manner on Stanford- compliant encrypted devices.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized at time of enrollment to either the control or intervention arms.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures
Actual Study Start Date : February 21, 2018
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : October 2, 2018

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 1-2L/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.
Device: High-flow nasal cannula
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 2L/kg/min with a maximum of 70L/min. This will be only for the duration of the surgery or procedure.




Primary Outcome Measures :
  1. Number of Surgical Interruptions [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.


Secondary Outcome Measures :
  1. Oxygen Desaturation Index [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Oxygen desaturation index is defined as the number of times a patient has a 4% decrease in saturation from a 120 second rolling mean for greater than 10 seconds

  2. Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%. [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Relative incidence of oxygen desaturation as measured by pulse oximetry by second adjusted for post surgical diagnosis

  3. Incidence of Oxygen Desaturation [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second

  4. Incidence of Adverse Events [ Time Frame: Up to 12 hours ]
  5. End-Tidal Carbon Dioxide (ETCO2) [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Ventilation was measured with transcutaneous carbon dioxide sensor


Other Outcome Measures:
  1. Post-surgical Diagnosis [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Location of lesion(s) according to post-surgical diagnosis

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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:   No
Criteria

Inclusion Criteria:

  • Pediatric patients less than or equal to 18 years old undergoing general anesthesia for procedures or surgeries at Lucile Packard Children's Hospital.

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), papillomatosis, tracheostomy, 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): NCT03430206


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Thomas J Caruso, M.D., M.Ed. Associate Clinical Professor
  Study Documents (Full-Text)

Documents provided by Thomas Caruso, Stanford University:
Study Protocol  [PDF] January 9, 2018
Statistical Analysis Plan  [PDF] July 9, 2020

Additional Information:
Publications:

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Responsible Party: Thomas Caruso, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03430206    
Other Study ID Numbers: IRB-43220
First Posted: February 12, 2018    Key Record Dates
Results First Posted: August 6, 2020
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are discussing with other facilities conducting research similar in description to or study for a possible multi-center study. If such coordination takes place, we anticipate all deidentified data collected with participating investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Thomas Caruso, Stanford University:
high-flow
nasal cannula
laryngoscopy
otolaryngology
oxygen
desaturation
anesthesia
pediatric
Additional relevant MeSH terms:
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Hypoventilation
Hypoxia
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory