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

NCT03430206 | Completed Results FDA Device

• 1 other identifier: IRB-43220
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxygen Deficiency; Desaturation of Blood; Hypoventilation; Anesthesia; Adverse Effect

Keywords

high-flow; nasal cannula; laryngoscopy; otolaryngology; oxygen; desaturation; anesthesia; pediatric

Outcome Measures

Primary Outcomes (1)

• Number of Surgical Interruptions

  Number of surgical interruptions defined by a pause in surgical procedures due to need to intervene, normalized to case length.

  Duration of surgery (generally less than 2 hours)

Secondary Outcomes (5)

• Oxygen Desaturation Index

  Duration of surgery (generally less than 2 hours)

• Number of Oxygen Desaturation Events <90% or Defined by a 5% Fall From Baseline if Baseline Saturation < 94%.

  Duration of surgery (generally less than 2 hours)

• Incidence of Oxygen Desaturation

  Duration of surgery (generally less than 2 hours)

• Incidence of Adverse Events

  Up to 12 hours

• End-Tidal Carbon Dioxide (ETCO2)

  Duration of surgery (generally less than 2 hours)

Other Outcomes (6)

• Post-surgical Diagnosis

  Duration of surgery (generally less than 2 hours)

• Gas Pain or Bloating

  Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.

• Nasal Irritation

  Evaluated postoperatively in post-anesthesia recovery unit prior to discharge, which is about 60 minutes postoperatively.

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (6)

• Humphreys S, Rosen D, Housden T, Taylor J, Schibler A. Nasal high-flow oxygen delivery in children with abnormal airways. Paediatr Anaesth. 2017 Jun;27(6):616-620. doi: 10.1111/pan.13151. Epub 2017 Apr 10.

  PMID: 28393433 BACKGROUND

• Doyle AJ, Stolady D, Mariyaselvam M, Wijewardena G, Gent E, Blunt M, Young P. Preoxygenation and apneic oxygenation using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for emergency intubation. J Crit Care. 2016 Dec;36:8-12. doi: 10.1016/j.jcrc.2016.06.011. Epub 2016 Jun 23.

  PMID: 27546740 BACKGROUND

• Mir F, Patel A, Iqbal R, Cecconi M, Nouraei SA. A randomised controlled trial comparing transnasal humidified rapid insufflation ventilatory exchange (THRIVE) pre-oxygenation with facemask pre-oxygenation in patients undergoing rapid sequence induction of anaesthesia. Anaesthesia. 2017 Apr;72(4):439-443. doi: 10.1111/anae.13799. Epub 2016 Dec 30.

  PMID: 28035669 BACKGROUND

• Humphreys S, Lee-Archer P, Reyne G, Long D, Williams T, Schibler A. Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) in children: a randomized controlled trial. Br J Anaesth. 2017 Feb;118(2):232-238. doi: 10.1093/bja/aew401.

  PMID: 28100527 BACKGROUND

• Gustafsson IM, Lodenius A, Tunelli J, Ullman J, Jonsson Fagerlund M. Apnoeic oxygenation in adults under general anaesthesia using Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) - a physiological study. Br J Anaesth. 2017 Apr 1;118(4):610-617. doi: 10.1093/bja/aex036.

  PMID: 28403407 BACKGROUND

• Desai N, Fowler A. Use of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange for Emergent Surgical Tracheostomy: A Case Report. A A Case Rep. 2017 Nov 1;9(9):268-270. doi: 10.1213/XAA.0000000000000589.

  PMID: 28622152 BACKGROUND

Related Links

• Anticipated Australian study of similar protocol

MeSH Terms

Conditions

Hypoxia; Hypoventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

Enrollment did not meet the threshold needed for statistical significance

Results Point of Contact

• Title: Thomas Caruso, MD, MEd
• Organization: Stanford University

tjcaruso@stanford.edu

(626) 275-0341

Study Officials

• Thomas J Caruso, M.D., M.Ed.

  Associate Clinical Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Patients are randomized at time of enrollment to either the control or intervention arms.

Study Record Dates

• First Submitted: January 20, 2018
• First Posted: February 12, 2018
• Study Start: February 21, 2018
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: August 6, 2020
• Results First Posted: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)