Difficult IntubationNCT05399147
Tube 1st Technique for Easy Fiberoptic Intubation
A study testing fiberoptic intubation classic technique and fiberoptic intubation tube 1st technique in people with Difficult Intubation, run by Ain Shams University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- fiberoptic intubation classic technique and fiberoptic intubation tube 1st technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Oct 2022
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 and 60 years,
- ASA Class I\& II,
- Maxillofacial surgeries ex: mandibular surgery, orthognathic surgery and dental extraction surgery,
- Other surgeries like: oral graft surgery, facial trauma, limited mouth opening ex: submandibular and facial abscess.
Who cannot join
- Patient's refusal,
- ASA III or more,
- Intrinsic and idiopathic coagulopathy,
- known allergy to any of the study medications,
- furthermore, patients were excluded if they had severe hypoxemias due to sever cardiac or lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tube First Technique as a Conduit for Easy and Fast Firberoptic Intubation
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].
- Conditions
- Difficult Intubation
- Being tested
- fiberoptic intubation classic technique, fiberoptic intubation tube 1st technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic intubation classic techniqueOther
classic fiberoptic intubation
fiberoptic intubation tube 1st techniqueOther
tube 1st technique
| Study group | Role | What they receive |
|---|---|---|
| classic group (CL group) | Other | 20 patients will be enrolled to be intubated using the classic usual technique Receives: Other: fiberoptic intubation classic technique |
| tube 1st group (TF group) | Other | 20 patients will be enrolled to be intubated using the tube 1st technique Receives: Other: fiberoptic intubation tube 1st technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
time 1
time 1 = time from start from start of introducing the bronchoscope till viewing the vocal cord measured in seconds.
Measured: baseline
Secondary outcomes (1)
other measures
- total dose of propofol during procedure measured in mg
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jul 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gaber, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399147
- Sponsor's protocol ID
- fiberoptic intubation
- Status last verified
- Oct 2022
- First submitted
- 19 Mar 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 11883389Allahyary 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 3354936Apfelbaum 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 23364566Wheeler 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tube First Technique as a Conduit for Easy and Fast Firberoptic Intubation
- ClinicalTrials.gov ID
- NCT05399147
- Acronym / sponsor ID
- fiberoptic intubation
- Conditions
- Difficult Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 1 Jun 2022 (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.
the aim of this work is to study how this technique will make nasal fiberoptic intubation easier and faster than the usual classic technique
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].
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic group (CL group) | Other | Other: fiberoptic intubation classic technique20 patients will be enrolled to be intubated using the classic usual technique |
| tube 1st group (TF group) | Other | Other: fiberoptic intubation tube 1st technique20 patients will be enrolled to be intubated using the tube 1st technique |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 and 60 years,
- ASA Class I\& II,
- Maxillofacial surgeries ex: mandibular surgery, orthognathic surgery and dental extraction surgery,
- Other surgeries like: oral graft surgery, facial trauma, limited mouth opening ex: submandibular and facial abscess.
Key exclusion criteria (5 listed)
- Patient's refusal,
- ASA III or more,
- Intrinsic and idiopathic coagulopathy,
- known allergy to any of the study medications,
- furthermore, patients were excluded if they had severe hypoxemias due to sever cardiac or lung disease
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 |
|---|---|---|
| fiberoptic intubation classic techniqueclassic fiberoptic intubation | Other | classic group (CL group) |
| fiberoptic intubation tube 1st techniquetube 1st technique | Other | tube 1st group (TF group) |
Primary outcome
time 1
Time frame: baseline
time 1 = time from start from start of introducing the bronchoscope till viewing the vocal cord measured in seconds.
1 secondary outcome
other measures
Time frame: baseline
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 14 Oct 2022.
- Background: PubMed 11883389Mak 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.
- BackgroundAllahyary 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.
- Background: PubMed 3354936Fontanarosa 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.
- Background: PubMed 23364566Apfelbaum 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.
- BackgroundWheeler 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.
- BackgroundMurphy 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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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiberoptic intubation classic technique and fiberoptic intubation tube 1st technique in people with Difficult Intubation, run by Ain Shams 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 5 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 14 Oct 2022. 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 1 (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05399147, which also lists 6 linked publications.
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 14 Oct 2022.