Application of THRIVE in Burn Children With Suspected Difficult Airway
NCT Number: NCT06459076
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intubation; Difficult or Failed
Interventions: DEVICE: Transnasal humidified rapid-insufflation ventilatory exchange (THRIVE)
Sponsor: Shuxiu Wang
Sex: ALL
Age: CHILD, ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2026-05

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.

Primary Outcome Measures: 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 Outcome Measures: 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 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