Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459076
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-01
Brief Title:
Application of THRIVE in Burn Children With Suspected Difficult Airway
Sponsor:
Shuxiu Wang
Organization:
The First Affiliated Hospital of Air Force Medicial University
Study Overview
Official Title:
Application of Transnasal Humidified Rapid-insufflation Ventilatory Exchange THRIVE in Burn Children With Suspected Difficult AirwayA Single-center Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 techniqueTHRIVE in children aged between 0 and 18 years who with head face and neck injuries by fire scalding chemical electricexplosions 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 childrens face and a THRIVE nasal plug was placed During intubation the Routine care group had no oxygen supplyand the THRIVE group will be maintained throughout the apnoeic period with selected flow rates during intubation attempts
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 childrens face and a THRIVE nasal plug was placed During intubation the Routine care group had no oxygen supplyand 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 obstructionespecially for these who burned with headface 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 HoweverIn 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 phaseTransnasal 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 thesniffing position with a 2-25 cm pad placed under shoulder in order to maintain upper airway patency Intravenous anesthesia was induced with fentanyl 2ugkg-1 and propofol 2-3mgkg-1 and vecuronium 01 mgkg-1 respectivelyfor children without or with difficulty in set up vein line 8 sevoflurane was inhaled and after IV access was establishedSevoflurane were discontinuedfollowed 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 90the 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-1and 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
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 phaseTransnasal 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 thesniffing position with a 2-25 cm pad placed under shoulder in order to maintain upper airway patency Intravenous anesthesia was induced with fentanyl 2ugkg-1 and propofol 2-3mgkg-1 and vecuronium 01 mgkg-1 respectivelyfor children without or with difficulty in set up vein line 8 sevoflurane was inhaled and after IV access was establishedSevoflurane were discontinuedfollowed 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 90the 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-1and 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None