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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

Tracking Information
First Submitted Date  ICMJE January 20, 2018
First Posted Date  ICMJE February 12, 2018
Results First Submitted Date  ICMJE July 16, 2020
Results First Posted Date  ICMJE August 6, 2020
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE February 21, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Relative Incidence of oxygen desaturation [ Time Frame: Duration of surgery or procedure by second ]
Relative incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second, normalized by case length.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • 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
  • 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
  • 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
  • Incidence of Adverse Events [ Time Frame: Up to 12 hours ]
  • End-Tidal Carbon Dioxide (ETCO2) [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Ventilation was measured with transcutaneous carbon dioxide sensor
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • 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%.
  • 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.
  • Relative number and severity of airway interventions due to desaturation [ Time Frame: Duration of surgery or procedure by second ]
    Number of Jaw thrust, bag mask ventilation, and/or endotracheal intubations due to desaturation, normalized by case length.
  • Incidence of Oxygen Desaturation [ Time Frame: Duration of surgery or procedure by second ]
    Absolute incidence of oxygen desaturation less than 90% as measured by pulse oximetry by second
Current Other Pre-specified Outcome Measures
 (submitted: July 16, 2020)
  • Post-surgical Diagnosis [ Time Frame: Duration of surgery (generally less than 2 hours) ]
    Location of lesion(s) according to post-surgical diagnosis
  • 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
  • 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
  • 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
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: February 5, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
 
Descriptive Information
Brief Title  ICMJE Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures
Official Title  ICMJE Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Use in Pediatric Procedures
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Oxygen Deficiency
  • Desaturation of Blood
  • Hypoventilation
  • Anesthesia; Adverse Effect
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: High-flow nasal cannula
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2020)
78
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2018)
40
Actual Study Completion Date  ICMJE October 2, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03430206
Other Study ID Numbers  ICMJE IRB-43220
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Thomas Caruso, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas J Caruso, M.D., M.Ed. Associate Clinical Professor
PRS Account Stanford University
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP