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CompletedNCT05399147Updated Oct 14, 2022

Tube 1st Technique for Easy Fiberoptic Intubation

An interventional study of fiberoptic intubation classic technique and fiberoptic intubation tube 1st technique in Difficult Intubation, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-14.

Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
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Study summary

the aim of this work is to study how this technique will make nasal fiberoptic intubation easier and faster than the usual classic technique

Read the detailed description

Difficult intubation is one of the most significant issues anesthesiologists deal with, occasionally. Among these, mandibulofacial deformities face the biggest challenge in intubation and make an anticipated difficult airway (1), due to short length of mandible (HLM), short thyromental distance (TMD), short inter horizontal -incisors gap (IIG) and high grade modified Mallampati test (MMT) (2).

There are several strategies to approach these patients and each technique has unique benefits that should be used on experience. Sitting endotracheal intubation is a useful technique for airway control, in patients with difficult airway or in patients in whom maintenance of the upright posture is beneficial (3), A difficult airway is defined as difficulty with facemask ventilation, difficulty with tracheal intubation, or both (3). According to new updates on difficult airway management, by the American Society of Anesthesiologists, there are non-invasive and invasive interventions for the management of difficult airway. Non-invasive interventions include, without being limited to: awake intubation, video-assisted laryngoscopy, intubating stylets or tube-changers, supraglottic airway (SGA) for ventilation (e.g., LMA, laryngeal tube), SGA for intubation (e.g., ILMA), rigid laryngoscopic blades of variousdesign and size, fiberoptic-guided intubation, and lighted stylets or light wands, while invasive interventions include surgical or percutaneous airway, jet ventilation and retrograde intubation (4).

Attaching a nasal airway to a breathing circuit as a tool to assist or control ventilation is a very helpful trick to have in challenging airway management situations.

Typically, Fiberoptic bronchoscope is passed through the more patent nostril to follow the major nasal pathway at the floor of the nose along the superior aspect of the hard palate, the lateral aspect of the nasal septum inferior to the lower turbinate to reach the nasopharynx where the operator identifies the pharyngeal structures, such as the base of the tongue and/or the epiglottis that are mostly "in-fall" precluding clear views of the larynx requiring a jaw thrust to visualize the laryngeal structures for patients planned to be intubated under general anesthesia [5,6].

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Conditions studied

  • Difficult Intubation
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In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age between 20 and 60 years,
  2. ASA Class I\& II,
  3. Maxillofacial surgeries ex: mandibular surgery, orthognathic surgery and dental extraction surgery,
  4. Other surgeries like: oral graft surgery, facial trauma, limited mouth opening ex: submandibular and facial abscess.

Exclusion criteria

Exclusion Criteria:

  1. Patient's refusal,
  2. ASA III or more,
  3. Intrinsic and idiopathic coagulopathy,
  4. known allergy to any of the study medications,
  5. furthermore, patients were excluded if they had severe hypoxemias due to sever cardiac or lung disease
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Other
    classic group (CL group)

    20 patients will be enrolled to be intubated using the classic usual technique

    Other: fiberoptic intubation classic technique

  • Other
    tube 1st group (TF group)

    20 patients will be enrolled to be intubated using the tube 1st technique

    Other: fiberoptic intubation tube 1st technique

Interventions

  • Otherfiberoptic intubation classic technique

    classic fiberoptic intubation

  • Otherfiberoptic intubation tube 1st technique

    tube 1st technique

06

What researchers measure

Primary outcomes

  1. time 1

    time 1 = time from start from start of introducing the bronchoscope till viewing the vocal cord measured in seconds.

    Time frame: baseline

Secondary outcomes

  1. other measures

    1. total dose of propofol during procedure measured in mg

    Time frame: baseline

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Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
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References and documents

Publications

  • Mak PH, Ooi RG. Submental intubation in a patient with beta-thalassaemia major undergoing elective maxillary and mandibular osteotomies. Br J Anaesth. 2002 Feb;88(2):288-91. doi: 10.1093/bja/88.2.288. PubMed 11883389 ↗
  • Allahyary E, Ghaemei SR, Azemati S. Comparison of six methods for predicting difficult intubation in obstetric patients. Iran Red Crescent Med J. 2008;10:197-204.
  • Fontanarosa PB, Goldman GE, Polsky SS, Schuckman HA, Poyle M. Sitting oral-tracheal intubation. Ann Emerg Med. 1988 Apr;17(4):336-8. doi: 10.1016/s0196-0644(88)80775-3. PubMed 3354936 ↗
  • Apfelbaum JL, Hagberg CA, Caplan RA, Blitt CD, Connis RT, Nickinovich DG, Hagberg CA, Caplan RA, Benumof JL, Berry FA, Blitt CD, Bode RH, Cheney FW, Connis RT, Guidry OF, Nickinovich DG, Ovassapian A; American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Practice guidelines for management of the difficult airway: an updated report by the American Society of Anesthesiologists Task Force on Management of the Difficult Airway. Anesthesiology. 2013 Feb;118(2):251-70. doi: 10.1097/ALN.0b013e31827773b2. No abstract available. PubMed 23364566 ↗
  • Wheeler M, Ovassapian A. Fiberoptic endoscopy-aided techniques. In: Benumof's airway management: principles and practice, 2nd ed., vol. 27(5). Mosby Elsevier Philadelphia; 2010. p. 461-67.
  • Murphy MF. Applied functional anatomy of the airway. In: Manual of emergency airway management, 3rd ed., vol. 3(2). USA: Lippincott Williams & Wilkins; 2008.p. 37-46.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05399147
Lead sponsor
Ain Shams University
Responsible party
Amr Gaber (lecturer, Ain Shams University) — Principal investigator
First posted
Jun 1, 2022
Start date
Jul 1, 2022
Primary completion
Sep 1, 2022
Completion
Oct 1, 2022
Last update
Oct 14, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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