Application of THRIVE in Burn Children With Suspected Difficult Airway

NCT ID: NCT06459076

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-05-31

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.

Detailed Description

The incidence of burns is four times higher in children than in adults: burn injuries account for about 25% of all paediatric hospitalisations. Approximately 70 percent of children who attend hospital with burns or scalds are less than five years of age. The most common cause is hot liquids. Direct heat and steam injury to the upper airway can lead to marked swelling of the face, tongue, epiglottis, and glottic opening, resulting in airway obstruction,especially for these who burned with head,face and neck. Dressings and nasogastric tubes may make face mask seal difficult, facial wounds may be painful, and exudate and topical antibiotics may make for a slippery surface and difficult for anesthesiologist to holding the mask during preoxygenation phase. However,In children, awake intubation is not a viable option. Therefore, intubation is often attempted after Rapid Sequence Intubation (RSI) by set up a vein line after inhalation anesthesia in the operating room. But the lower functional residual capacity and greater metabolic demand of children made the onset of desaturation in apnoeic children occurs much faster than in adults at induction of anaesthesia and is known to be age dependent. If the desaturation occurs, oxygen mask is often required to manually assist ventilation, until SPO2 recovery after another attempt to intubation. Attempting more than two tracheal intubations in children with difficult endotracheal intubation is associated with a high failure rate and increased incidence of complications.

Preoxygenation does not supply an ongoing gas exchange and therefore there is an urgent need for newer methods to continue improved oxygenation during the apnoeic phase.Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) has potential in pre-oxygenation for RSI anaesthesia since it provides high-flow humidified oxygen through nasal cannulae and allows continued peri-laryngoscopy oxygen delivery during apnoea.

Therefore, investigator propose the hypothesis that children with head, face, and neck burns or thermal scalds use THRIVE during endotracheal intubation after anesthesia induction, It can prolong the safe apnoea oxygenation time and increase the success rate of the first intubation without SPO2 decrease ≤90%.

No sedative was applied before patients entering the operating room. All patients were put in the"sniffing" position with a 2-2.5 cm pad placed under shoulder in order to maintain upper airway patency. Intravenous anesthesia was induced with fentanyl 2ug/kg-1 and propofol 2-3mg/kg-1 and vecuronium 0.1 mg/kg-1, respectively,(for children without or with difficulty in set up vein line, 8% sevoflurane was inhaled, and after I.V. access was established,Sevoflurane were discontinued,followed by Intravenous induction), (The preoxygenation phase is defined as the period in preparation for intubation where oxygen is delivered to The patient to maximize oxygen concentration in the functional residual capacity of The lung), and wait 2-3 min for vecuronium to takes effect after reaching end-expiratory oxygen saturation > 90%,the manual ventilation is stopped and according to different groups, different intervention was performed. Routine care group: after stopping manual ventilation, the inestigators immediately removed the mask and placed the nasal plug in place but without oxygen supply, and the anesthesiologist began to intubation; THRIVE group: after stopping manual ventilation, the investigators immediately ceasing assisted ventilation, 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: 0-15kg, 2litres KG-1 Min-1; 15-30kg, 35litres Min-1; 30-50kg, 40litres Min-1; and & GT; 50kg, 50litres Min-1,and start to tracheal intubation.

If SPO2 ≤ 90% appears during intubation, then perform manual ventilation immediately until SPO2 returned to 100% endotracheal intubation was performed again and recorded as second attempt intubation.

Monitoring of anesthetic depth was not possible because The surgical site involved The head and face.

Conditions

Intubation; Difficult or Failed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Routine Care group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

THRIVE group

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

Group Type: EXPERIMENTAL

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)

Intervention Type: 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.

Interventions

Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shuxiu Wang

OTHER

Sponsor Role: lead

Responsible Party

Shuxiu Wang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

shuxiu wang, PH.D

Role: PRINCIPAL_INVESTIGATOR

The Xijing Hospital of Air Force Military Medical University

Central Contacts

dandan cheng, PH.D

Role: CONTACT

wangshuxiuzi@163.com

+86 029 84775343

References

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.

Reference Type: RESULT

PMID: 32147581 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24034453 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25485468 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26705976 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25388828 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28100527 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35476651 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30401594 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22424653 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/32147581/

PubMed ID:32147581

https://pubmed.ncbi.nlm.nih.gov/24034453/

PubMed ID:24034453

https://pubmed.ncbi.nlm.nih.gov/25485468/

PubMed ID:25485468

https://pubmed.ncbi.nlm.nih.gov/26705976/

PubMed ID:26705976

https://pubmed.ncbi.nlm.nih.gov/25388828/

PubMed ID:25388828

https://pubmed.ncbi.nlm.nih.gov/28100527/

PubMed ID:28100527

https://pubmed.ncbi.nlm.nih.gov/35476651/

PubMed ID:35476651

https://pubmed.ncbi.nlm.nih.gov/30401594/

PubMed ID:30401594

https://pubmed.ncbi.nlm.nih.gov/22424653/

PubMed ID:22424653

Other Identifiers

1stAHAirforceMedicalU

Identifier Type: -

Identifier Source: org_study_id