IntubationNCT06300437
The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program
A study testing jaw thrust in people with Intubation, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Intubation
- What is being tested?
- jaw thrust
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children more than 1-year of age
- American Society of Anesthesiologists physical status I-II
- scheduled for elective surgery under general anesthesia.
Who cannot join
- Patients known or suspected difficult intubation.
- Patients with syndrome known to be associated with difficult intubation.
- Patients with severe pulmonary or cardiac diseases.
- Patients at risk of aspiration (patients with lower esophageal disease such as Hiatus hernia, or GERD and DM).
- Body mass index (BMI) greater than 35 kg/m2.
- Refusal of the patient guardians.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program, a Randomized Controlled Trial
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.
Read the 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 0.01mg/kg with a minimum of 0.1mg will be given and anesthesia will be completed with 1µ/kg fentanyl and 0.5 mg/kg Atracurium. Children will then be preoxygenated using appropriate mask and volume-controlled ventilation (VCV) using (G.E-Datex-Ohmeda, Avance CS2, USA). Ventilation will be set at 6 ml/kg, 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) 4.0 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 child's 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.
- Conditions
- Intubation
- Being tested
- jaw thrust, control (sub laxed jaw)
- Keywords
- fiberoptic, intubation, children, training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
jaw thrustProcedure or surgery
children who will receive jaw thrusting during fiberoptic intubation
control (sub laxed jaw)Procedure or surgery
children who will not receive jaw thrusting (just sub laxed open mouth)
| Study group | Role | What they receive |
|---|---|---|
| Group jaw thrust | Experimental | will include the children who will receive jaw thrusting during fiberoptic intubation. Receives: Procedure: jaw thrust |
| Group control | Active comparator | will include the children who will not receive jaw thrusting (just sub laxed open mouth) Receives: Procedure: control (sub laxed jaw) |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to successful endotracheal tube insertion
time to successful endotracheal tube insertion (defined as time from face mask removal until direct visualization of the ETT in the trachea by the fiberscope after sliding of the ETT over the fiberscope).
Measured: 3 minutes
Secondary outcomes (2)
Number of attempts to successful intubation
Number of attempts to successful intubation
Measured: 3 minutes
Complication
example: airway trauma, severe desaturation SPO2 below 90%
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start3 Mar 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
- Investigators
- Khaled Sarhan, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300437
- Sponsor's protocol ID
- MS-372-2023
- Status last verified
- Aug 2025
- First submitted
- 3 Mar 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06300437
- Acronym / sponsor ID
- MS-372-2023
- Conditions
- Intubation
- Keywords
- fiberoptic, intubation, children, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 0.01mg/kg with a minimum of 0.1mg will be given and anesthesia will be completed with 1µ/kg fentanyl and 0.5 mg/kg Atracurium. Children will then be preoxygenated using appropriate mask and volume-controlled ventilation (VCV) using (G.E-Datex-Ohmeda, Avance CS2, USA). Ventilation will be set at 6 ml/kg, 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) 4.0 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 child's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model 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)
| Arm | Type | Receives |
|---|---|---|
| Group jaw thrust | Experimental | Procedure: jaw thrustwill include the children who will receive jaw thrusting during fiberoptic intubation. |
| Group control | Active comparator | Procedure: control (sub laxed jaw)will include the children who will not receive jaw thrusting (just sub laxed open mouth) |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children more than 1-year of age
- American Society of Anesthesiologists physical status I-II
- scheduled for elective surgery under general anesthesia.
Key exclusion criteria (6 listed)
- Patients known or suspected difficult intubation.
- Patients with syndrome known to be associated with difficult intubation.
- Patients with severe pulmonary or cardiac diseases.
- Patients at risk of aspiration (patients with lower esophageal disease such as Hiatus hernia, or GERD and DM).
- Body mass index (BMI) greater than 35 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| jaw thrustchildren who will receive jaw thrusting during fiberoptic intubation | Procedure or surgery | Group jaw thrust |
| control (sub laxed jaw)children who will not receive jaw thrusting (just sub laxed open mouth) | Procedure or surgery | Group control |
Primary outcome
time to successful endotracheal tube insertion
Time frame: 3 minutes
time to successful endotracheal tube insertion (defined as time from face mask removal until direct visualization of the ETT in the trachea by the fiberscope after sliding of the ETT over the fiberscope).
2 secondary outcomes
Number of attempts to successful intubation
Time frame: 3 minutes
Complication
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Intubation
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Vagal Stimulator to Reduce Nasogastric Tube Use
Nasogastric Tube Intubation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khaled Sarhan principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing jaw thrust in people with Intubation, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to successful endotracheal tube insertion (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.