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Completed

NCT Number: NCT03430206

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

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.

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Key information

Conditions

Oxygen Deficiency Anesthesia; Adverse Effect Desaturation of Blood Hypoventilation Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-flow nasal cannula

Device

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 12, 2018
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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