Video-assistedNCT06776900
Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery
A study testing Supine position and Lateral position in people with Video-assisted and Head and Neck Surgery, run by Cairo University at 1 site in Egypt.
Trial summary
Fiberoptic intubation was first described in the late 1960s and has since become an effective and well-established technique for airway management in awake, sedated, and anesthetized patients. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Video-assisted, Head and Neck Surgery, Intubation
- What is being tested?
- Supine position and Lateral position
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-10 years old.
- Both genders.
- ASA physical status I and II.
- Elective non-head-and-neck surgeries.
Who cannot join
- Refusal of patients.
- Head and neck surgeries or with history of previous ones.
- Head, neck and lung congenital deformities or pathologies.
- Patients with expected difficult intubation (based on examination).
- Patients with neuromuscular disorders.
- Hypoxia: defined as low oxygen saturation (SpO2) ≤ 95% on room air.
- Trauma patients or patients requiring emergency procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo
Kareem MA Nawwar, +201003878369, drknawwar@cu.edu.eg
About this study
Official title: Video-assisted Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery: a Randomized Controlled Non-inferiority Trial
Fiberoptic intubation was first described in the late 1960s and has since become an effective and well-established technique for airway management in awake, sedated, and anesthetized patients. This technique is especially useful in patients with known or suspected difficult airways such as those with limited mouth opening, reduced neck mobility, cervical spine injury, obesity, or an elevated risk for aspiration. The benefits of fiberoptic intubation also include fewer complications such as tooth injury and oropharyngeal bleeding; and the opportunity for optimal positioning of double-lumen tubes in patients undergoing thoracic surgery.
Anesthesiologists may be confronted with situations in which patients in a lateral position during surgery experience an accidental loss of airway patency. Intubation with direct laryngoscopy is more challenging and time-consuming in patients in the lateral position than in the supine position, particularly when there is an abrupt loss of airway patency, as demonstrated by prior research. These observations suggest that there is an unmet need for a reliable method of airway management for patients in the lateral position. Although the airway is of a larger caliber and ventilation renders less peak and better oxygenation when patients are in the lateral position, glottic view was unfavorable for intubation when Macintosh direct laryngoscope was used in this position. This could be the reason why such a procedure is unfamiliar in anesthesia even when it is the most needed in special situations. Flexible fiberoptic intubation in lateral position would be convenient in emergency situations like accidental extubation during surgery or inadequate regional anesthesia requiring general anesthesia. Flexible fiberoptic intubation in lateral position would be of significant assistance in neurosurgical patients especially those with occipital lesions and patients with difficult airway scores with limited mouth opening or neck extension.
After thorough literature review, we found that studies comparing flexible video-assisted fiberoptic intubation in the lateral versus supine position in pediatrics are lacking.
- Conditions
- Video-assisted, Head and Neck Surgery, Intubation
- Being tested
- Supine position, Lateral position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine positionProcedure or surgery
An assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10).
The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to glide the suitable ETT into the trachea. Once the ETT is connected to the mechanical ventilator, chest auscultation and capnography waves will be used to confirm a successful intubation.
At any intubation attempt where SpO2 reaches 90%, the procedure will be suspended and mechanical ventilation via a facemask applied till SpO2 of 100% achieved.
Lateral positionProcedure or surgery
An assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10).
The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to glide the suitable ETT into the trachea. Once the ETT is connected to the mechanical ventilator, chest auscultation and capnography waves will be used to confirm a successful intubation.
At any intubation attempt where SpO2 reaches 90%, the procedure will be suspended and mechanical ventilation via a facemask applied till SpO2 of 100% achieved.
| Study group | Role | What they receive |
|---|---|---|
| Supine group | Active comparator | the patient will be kept in supine position with the head placed neutrally and a roll under the shoulders Receives: Procedure: Supine position |
| Lateral group | Active comparator | the patient will be positioned in the lateral position with head and neck physiologically aligned with head positioner. The dependent leg will be flexed at the hip and knee and the upper leg will be straight with a pillow between both legs Receives: Procedure: Lateral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to intubation
time from inserting the endoscope between teeth in the first intubation attempt, till successful display of end tidal carbon dioxide (ETCO2) waveform on capnography
Measured: 5 minutes from endoscope insertion between teeth
Secondary outcomes (4)
Rate of successful intubation at first attempt.
each intubation trial will be labelled as successful from first, second or third attempt or failed
Measured: 5 minutes from endoscope insertion between teeth
Overall number of intubation attempts
each intubation trial will be labelled as successful from first, second or third attempt or failed
Measured: 5 minutes from endoscope insertion between teeth
Incidence of complications
Oesophageal intubation, Lip, tongue or dental injury, Oxygen desaturation (SpO2 ≤ 92%), or Bronchospasm
Measured: 10 minutes from endoscope insertion between teeth
Oxygen saturation
just before and immediately after successful intubation
Measured: 5 minutes from endoscope insertion between teeth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start18 Jan 2025
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assistedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Mohammed Assem Nawwar, Cairo University
- Investigators
- Mariam KE Mohammed, MBBCh, Principal investigator, Cairo UniversityKarim KF Girgis, M.D., Study chair, Cairo UniversitySherif M Soaida, M.D., Study director, Cairo UniversityKareem MA Nawwar, M.D., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776900
- Sponsor's protocol ID
- MS-526-2024
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-assisted Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery: a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06776900
- Acronym / sponsor ID
- MS-526-2024
- Conditions
- Video-assisted, Head and Neck Surgery, Intubation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jan 2025 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 15 Jan 2025 (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.
Fiberoptic intubation was first described in the late 1960s and has since become an effective and well-established technique for airway management in awake, sedated, and anesthetized patients. This technique is especially useful in patients with known or suspected difficult airways such as those with limited mouth opening, reduced neck mobility, cervical spine injury, obesity, or an elevated risk for aspiration. The benefits of fiberoptic intubation also include fewer complications such as tooth injury and oropharyngeal bleeding; and the opportunity for optimal positioning of double-lumen tubes in patients undergoing thoracic surgery.
Anesthesiologists may be confronted with situations in which patients in a lateral position during surgery experience an accidental loss of airway patency. Intubation with direct laryngoscopy is more challenging and time-consuming in patients in the lateral position than in the supine position, particularly when there is an abrupt loss of airway patency, as demonstrated by prior research. These observations suggest that there is an unmet need for a reliable method of airway management for patients in the lateral position. Although the airway is of a larger caliber and ventilation renders less peak and better oxygenation when patients are in the lateral position, glottic view was unfavorable for intubation when Macintosh direct laryngoscope was used in this position. This could be the reason why such a procedure is unfamiliar in anesthesia even when it is the most needed in special situations. Flexible fiberoptic intubation in lateral position would be convenient in emergency situations like accidental extubation during surgery or inadequate regional anesthesia requiring general anesthesia. Flexible fiberoptic intubation in lateral position would be of significant assistance in neurosurgical patients especially those with occipital lesions and patients with difficult airway scores with limited mouth opening or neck extension.
After thorough literature review, we found that studies comparing flexible video-assisted fiberoptic intubation in the lateral versus supine position in pediatrics are lacking.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine group | Active comparator | Procedure: Supine positionthe patient will be kept in supine position with the head placed neutrally and a roll under the shoulders |
| Lateral group | Active comparator | Procedure: Lateral positionthe patient will be positioned in the lateral position with head and neck physiologically aligned with head positioner. The dependent leg will be flexed at the hip and knee and the upper leg will be straight with a pillow between both legs |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 2-10 years old.
- Both genders.
- ASA physical status I and II.
- Elective non-head-and-neck surgeries.
Key exclusion criteria (7 listed)
- Refusal of patients.
- Head and neck surgeries or with history of previous ones.
- Head, neck and lung congenital deformities or pathologies.
- Patients with expected difficult intubation (based on examination).
- Patients with neuromuscular disorders.
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 |
|---|---|---|
| Supine positionAn assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10). The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to glide the suitable ETT into the trachea. Once the ETT is connected to the mechanical ventilator, chest auscultation and capnography waves will be used to confirm a successful intubation. At any intubation attempt where SpO2 reaches 90%, the procedure will be suspended and mechanical ventilation via a facemask applied till SpO2 of 100% achieved. | Procedure or surgery | Supine group |
| Lateral positionAn assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10). The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to glide the suitable ETT into the trachea. Once the ETT is connected to the mechanical ventilator, chest auscultation and capnography waves will be used to confirm a successful intubation. At any intubation attempt where SpO2 reaches 90%, the procedure will be suspended and mechanical ventilation via a facemask applied till SpO2 of 100% achieved. | Procedure or surgery | Lateral group |
Primary outcome
Time to intubation
Time frame: 5 minutes from endoscope insertion between teeth
time from inserting the endoscope between teeth in the first intubation attempt, till successful display of end tidal carbon dioxide (ETCO2) waveform on capnography
4 secondary outcomes
Rate of successful intubation at first attempt.
Time frame: 5 minutes from endoscope insertion between teeth
Overall number of intubation attempts
Time frame: 5 minutes from endoscope insertion between teeth
Incidence of complications
Time frame: 10 minutes from endoscope insertion between teeth
Oxygen saturation
Time frame: 5 minutes from endoscope insertion between teeth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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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.
Mariam KE Mohammed, MBBCh principal investigator
Cairo University
Karim KF Girgis, M.D. study chair
Cairo University
Sherif M Soaida, M.D. study director
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 Supine position and Lateral position in people with Video-assisted and Head and Neck Surgery, run by Cairo University 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kareem MA Nawwar, M.D. (+201003878369, drknawwar@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to intubation (time frame: 5 minutes from endoscope insertion between teeth). 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 22 Jan 2025.