Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300437
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-03
Brief Title:
The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program
Sponsor:
Kasr El Aini Hospital
Organization:
Kasr El Aini Hospital
Study Overview
Official Title:
The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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 this study the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program
Detailed Description:
In this study children undergoing elective surgery under general anesthesia will be randomized into 2 groups
Group J will include the children who will receive jaw thrusting during fiberoptic intubation
Group C will include the children who will not receive jaw thrusting just sub laxed open mouth Following approval from the Research and Ethics Committee of the anesthesia department Faculty of Medicine Cairo University and obtaining written informed consent from all participating children parents meeting the inclusion criteria children will be randomly assigned into two groups using a computer-generated random number list with a closed-sealed envelope
Group J will include the children who will receive jaw thrusting during fiberoptic intubation
Group C will include the children who will not receive jaw thrusting just sub laxed open mouth The day before the operation all children guardians will be instructed to follow institutional fasting guidelines a minimum of 2 h for clear fluids 4 h for breast milk and 6 h for formula feeding or light meals
All children will receive an inhalation induction with sevoflurane in oxygen 100 and will be monitored with pulse oximetry noninvasive blood pressure monitoring electrocardiography and end-tidal carbon dioxide monitoring An intravenous line will be inserted Atropine 001mgkg with a minimum of 01mg will be given and anesthesia will be completed with 1µkg fentanyl and 05 mgkg Atracurium Children will then be preoxygenated using appropriate mask and volume-controlled ventilation VCV using GE-Datex-Ohmeda Avance CS2 USA Ventilation will be set at 6 mlkg respiratory rate of 20 and PEEP 3 cmH2O with 100 O2 and 2 sevoflurane for at least 3 min before intubation attempts Adequate ventilation will be ensured using end-tidal carbon dioxide monitoring At least 4 randomly selected residents will participate in the study The residents performing the fiberoptic intubations will not be involved in induction of anesthesia for the children Each resident had completed at least 2 years of anesthesia residency training program and had at least 5 fiberoptic intubation on mannequin under supervision of the airway management committee members in Kasr Alainy Cairo University All residents will receive the same orientation to using fiberscopes in children before their first intubation attempt Each resident will attempt fiberoptic intubation in at least 10 patients in each group randomly under direct guidance of the same attending senior anesthesiologist The fiberoptic Storz Flexible intubation video endoscope FIVE 40 mmx65cm attached to the multifunctional C-MAC monitor will be prepared by an anesthesia nurse using an antifogging solution and a suction catheter will be applied to the suction channel and connected to the wall vacuum All endotracheal tubes will be loaded onto the fiberscope with the Murphy eye up bevel facing down which will be kept in position using adhesive tape throughout the whole procedure to facilitate successful placement of endotracheal tube into the trachea The supervising anesthesiologist not blinded to the assigned group will secure the childs head in a neutral position and held the mouth open and the jaw sub laxed while providing verbal instruction to the assigned resident in the controlled group while in the jaw thrust group the supervising anesthesiologist will maintain the jaw thrusted while giving instruction to the training resident by placing the index and middle fingers to push the posterior aspects of the lower jaw upwards while his thumbs push down on the chin to open the mouth Instruction for the residents will be based on the shared view of the airway on the fiberoptic screen during the course of intubation During intubation the anesthesia nurse will use a stopwatch to measure the duration of each intubation attempt and the time from mask removal to confirmation of endotracheal tube placement by direct visualization of the ETT in the trachea An intubation attempt will be aborted if there is a decrease in oxygen saturation to 93 before completion of intubation or if the attempt takes longer than 3 min The patients will be ventilated with 100 O2 and 3 sevoflurane for 3 min between attempts Three attempts will be permitted for fiberoptic intubation If 3 attempts for fiberoptic intubation failed the child will be intubated using direct laryngoscope and the child will be excluded from the study The number of attempts required for successful completion of intubation will be recorded the failure rate and the cause of failure failure to correctly place the fiberscope or failure to thread the endotracheal tube into the trachea will be recorded
Group J will include the children who will receive jaw thrusting during fiberoptic intubation
Group C will include the children who will not receive jaw thrusting just sub laxed open mouth Following approval from the Research and Ethics Committee of the anesthesia department Faculty of Medicine Cairo University and obtaining written informed consent from all participating children parents meeting the inclusion criteria children will be randomly assigned into two groups using a computer-generated random number list with a closed-sealed envelope
Group J will include the children who will receive jaw thrusting during fiberoptic intubation
Group C will include the children who will not receive jaw thrusting just sub laxed open mouth The day before the operation all children guardians will be instructed to follow institutional fasting guidelines a minimum of 2 h for clear fluids 4 h for breast milk and 6 h for formula feeding or light meals
All children will receive an inhalation induction with sevoflurane in oxygen 100 and will be monitored with pulse oximetry noninvasive blood pressure monitoring electrocardiography and end-tidal carbon dioxide monitoring An intravenous line will be inserted Atropine 001mgkg with a minimum of 01mg will be given and anesthesia will be completed with 1µkg fentanyl and 05 mgkg Atracurium Children will then be preoxygenated using appropriate mask and volume-controlled ventilation VCV using GE-Datex-Ohmeda Avance CS2 USA Ventilation will be set at 6 mlkg respiratory rate of 20 and PEEP 3 cmH2O with 100 O2 and 2 sevoflurane for at least 3 min before intubation attempts Adequate ventilation will be ensured using end-tidal carbon dioxide monitoring At least 4 randomly selected residents will participate in the study The residents performing the fiberoptic intubations will not be involved in induction of anesthesia for the children Each resident had completed at least 2 years of anesthesia residency training program and had at least 5 fiberoptic intubation on mannequin under supervision of the airway management committee members in Kasr Alainy Cairo University All residents will receive the same orientation to using fiberscopes in children before their first intubation attempt Each resident will attempt fiberoptic intubation in at least 10 patients in each group randomly under direct guidance of the same attending senior anesthesiologist The fiberoptic Storz Flexible intubation video endoscope FIVE 40 mmx65cm attached to the multifunctional C-MAC monitor will be prepared by an anesthesia nurse using an antifogging solution and a suction catheter will be applied to the suction channel and connected to the wall vacuum All endotracheal tubes will be loaded onto the fiberscope with the Murphy eye up bevel facing down which will be kept in position using adhesive tape throughout the whole procedure to facilitate successful placement of endotracheal tube into the trachea The supervising anesthesiologist not blinded to the assigned group will secure the childs head in a neutral position and held the mouth open and the jaw sub laxed while providing verbal instruction to the assigned resident in the controlled group while in the jaw thrust group the supervising anesthesiologist will maintain the jaw thrusted while giving instruction to the training resident by placing the index and middle fingers to push the posterior aspects of the lower jaw upwards while his thumbs push down on the chin to open the mouth Instruction for the residents will be based on the shared view of the airway on the fiberoptic screen during the course of intubation During intubation the anesthesia nurse will use a stopwatch to measure the duration of each intubation attempt and the time from mask removal to confirmation of endotracheal tube placement by direct visualization of the ETT in the trachea An intubation attempt will be aborted if there is a decrease in oxygen saturation to 93 before completion of intubation or if the attempt takes longer than 3 min The patients will be ventilated with 100 O2 and 3 sevoflurane for 3 min between attempts Three attempts will be permitted for fiberoptic intubation If 3 attempts for fiberoptic intubation failed the child will be intubated using direct laryngoscope and the child will be excluded from the study The number of attempts required for successful completion of intubation will be recorded the failure rate and the cause of failure failure to correctly place the fiberscope or failure to thread the endotracheal tube into the trachea will be recorded
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