Application of THRIVE in Burn Children With Suspected Difficult Airway

NCT06459076 | Not Yet Recruiting DMC

• 1 other identifier: 1stAHAirforceMedicalU
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

In order to improve intubation conditions in burn children, our aim is to investigate the efficacy of transnasal humidified rapid-insufflation ventilatory exchange technique（THRIVE) in children aged between 0 and 18 years who with head, face, and neck injuries by fire, scalding, chemical, electric,explosions, and others. We hypothesise that THRIVE increases first attempt success without hypoxemia in intubation of children and compared with routine practice. Does the THRIVE can prolong apnoea time and delay the onset of desaturation to increase the success rate of the first tracheal intubation without desaturation? Researchers will compare THRIVE group with Routine care group to see successful intubation on the first attempt without desaturation. Participants will received intravenous anesthesia induction, followed by 2-3 minutes preoxygenation, before intubation, the mask was removed from the children's face and a THRIVE nasal plug was placed. During intubation, the Routine care group had no oxygen supply,and the THRIVE group will be maintained throughout the apnoeic period with selected flow rates during intubation attempts.

Conditions

Intubation; Difficult or Failed

Keywords

THRIVE; burn children; airway; intubation

Outcome Measures

Primary Outcomes (1)

• Rate of successful intubation on the first attempt without physiological instability

  Physiological instability is defined as SPO2≤90% at any time after induction of anesthesia until endotracheal intubation is completed. A successful first attempt intubation is defined as a successful intubation at first attempt without any desaturation (SpO2≤90% or saturation difference ≥10% for who after pre-oxygenation SpO2 cannot reach 100%). Successful intubation was defined as completion of the intubation attempt with correct placement of the endotracheal tube, as confirmed by the detection of expired carbon dioxide with a colorimetric detector.

  through study completion, an average of 2 years

Secondary Outcomes (1)

• Rate of hypoxemia; time to and duration of desaturation during the intubation attempt; the duration and number of intubation attempts; nadir SPO2 and heart rate during intubation attempt.

  through study completion, an average of 2 years

Study Arms (2)

Routine Care group

NO INTERVENTION

After induction of general intravenous anesthesia, 100% oxygen mask ventilation was used for pre-oxygenation, wait 2-3 min to vecuronium take effect and reaching end-expiratory oxygen saturation \> 90%, the Optiflow THRIVETM system nasal plug is placed in the proper position, but without oxygen supply, and the tracheal intubation is started.

THRIVE group

EXPERIMENTAL

After induction of general intravenous anesthesia, 100% oxygen mask ventilation was used for pre-oxygenation, wait 2-3 min to vecuronium take effect and reaching end-expiratory oxygen saturation \> 90%, Immediately after ceasing assisted ventilation, the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using the(Transnasal humidified rapid-insufflation ventilatory exchange, THRIVE) Optiflow THRIVE TM system. The flow rates applied were as follows: 0-15 kg, 2 litres kg-1 min-1；15-30 kg, 35 litres min-1; 30-50 kg, 40 litres min-1; and\>50 kg, 50 litres min-1,and the tracheal intubation is started

Device: Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)

Interventions

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) DEVICE

Immediately after ceasing assisted ventilation, before intubation the age-appropriate nasal prongs were applied and weight-specific high flow rates delivered using the Optiflow THRIVETM system. The flow rates applied were as follows: 0-15 kg, 2 litres kg-1 min-1；15-30 kg, 35 litres min-1; 30-50 kg, 40 litres min-1; and\>50 kg, 50 litres min-1.

THRIVE group

Eligibility Criteria

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

You may qualify if:

• \< 18 years
• ASA Grade I \~ III
• Children with head, face and neck scald or burn or flame or electrical c hemical or other

You may not qualify if:

• Refusal or failure to sign an informed consent
• Proposed to transnasal intubation
• Fracture of the nasal bone, nasal bleeding, nasal deformity or obstruction
• Tracheotomy status or severe head, face and neck burn or burn scar (difficult airway)
• Unsuitable for rapid sequence induction
• Basicranial fracture
• Cyanotic congenital heart defect
• At risk of malignant hyperthermia
• And is participating in other clinical studies

Sponsors & Collaborators

• Shuxiu Wang: lead

Related Publications (9)

• Legrand M, Barraud D, Constant I, Devauchelle P, Donat N, Fontaine M, Goffinet L, Hoffmann C, Jeanne M, Jonqueres J, Leclerc T, Lefort H, Louvet N, Losser MR, Lucas C, Pantet O, Roquilly A, Rousseau AF, Soussi S, Wiramus S, Gayat E, Blet A. Management of severe thermal burns in the acute phase in adults and children. Anaesth Crit Care Pain Med. 2020 Apr;39(2):253-267. doi: 10.1016/j.accpm.2020.03.006. Epub 2020 Mar 5.

  PMID: 32147581 RESULT

• Jeschke MG, Herndon DN. Burns in children: standard and new treatments. Lancet. 2014 Mar 29;383(9923):1168-78. doi: 10.1016/S0140-6736(13)61093-4. Epub 2013 Sep 11.

  PMID: 24034453 RESULT

• Bittner EA, Shank E, Woodson L, Martyn JA. Acute and perioperative care of the burn-injured patient. Anesthesiology. 2015 Feb;122(2):448-64. doi: 10.1097/ALN.0000000000000559.

  PMID: 25485468 RESULT

• Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.

  PMID: 26705976 RESULT

• Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10.

  PMID: 25388828 RESULT

• 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 RESULT

• Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.

  PMID: 35476651 RESULT

• Overmann KM, Boyd SD, Zhang Y, Kerrey BT. Apneic oxygenation to prevent oxyhemoglobin desaturation during rapid sequence intubation in a pediatric emergency department. Am J Emerg Med. 2019 Aug;37(8):1416-1421. doi: 10.1016/j.ajem.2018.10.030. Epub 2018 Oct 18.

  PMID: 30401594 RESULT

• Kerrey BT, Rinderknecht AS, Geis GL, Nigrovic LE, Mittiga MR. Rapid sequence intubation for pediatric emergency patients: higher frequency of failed attempts and adverse effects found by video review. Ann Emerg Med. 2012 Sep;60(3):251-9. doi: 10.1016/j.annemergmed.2012.02.013. Epub 2012 Mar 15.

  PMID: 22424653 RESULT

Related Links

• PubMed ID:32147581
• PubMed ID:24034453
• PubMed ID:25485468
• PubMed ID:26705976
• PubMed ID:25388828
• PubMed ID:28100527
• PubMed ID:35476651
• PubMed ID:30401594
• PubMed ID:22424653

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• shuxiu wang, PH.D

  The Xijing Hospital of Air Force Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

dandan cheng, PH.D

CONTACT

+86 029 84775343; wangshuxiuzi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 14, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share