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

Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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.
- 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
- 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

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 |
Principal Investigator: | Thomas J Caruso, M.D., M.Ed. | Associate Clinical Professor |
Documents provided by Thomas Caruso, Stanford University:
Publications:
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. |
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 |
high-flow nasal cannula laryngoscopy otolaryngology |
oxygen desaturation anesthesia pediatric |
Hypoventilation Hypoxia Respiratory Insufficiency |
Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |