Application of THRIVE in Burn Children With Suspected Difficult Airway

July 2, 2024 updated by: Shuxiu Wang

Application of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) in Burn Children With Suspected Difficult Airway：A Single-center, Randomized Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Study Population

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.These children with head,face and neck injury,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 holding the mask for the anesthesiologist ;In the early stage of burn, the direct injury of hot liquid or the inhalation of steam will cause the edema of mouth,lips and tongue , epiglottis even glottis;

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of successful intubation on the first attempt without physiological instability
Time Frame: through study completion, an average of 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: through study completion, an average of 2 years

Time to desaturation was defined as the time in seconds from ceasing assisted ventilation until the SpO2 first dropped below 90%.

The duration of desaturation the time from the initial drop below 90% until the SpO2 rose above 100% again.

An intubation attempt was defined as the insertion of the laryngoscope blade beyond the patient's lips until its removal from the patient's mouth, whether or not an attempt was made to insert an endotracheal tube. or where there is a change in operator during the procedure even if the device is not removed.

Intubation time was defined as the time from the start of laryngoscopy, when the blade was introduced between the teeth, until the first breath with the tracheal tube in place, verified by capnography.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shuxiu Wang

Investigators

  • Principal Investigator: shuxiu wang, PH.D, The Xijing Hospital of Air Force Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 1, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1stAHAirforceMedicalU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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