Difficult AirwayNCT06836388
Using Ultrasound for Bougie Insertion in Difficult Airway Management
A study testing ultrasound guided bougie insertion and Conventional methods for bougie insertion in people with Difficult Airway, run by Mohammed Gaber Saad at 1 site in Egypt.
Trial summary
Difficult airway management remains one of the biggest challenges in anesthesia practice. The Gum elastic bougie, an intubation tool, is frequently used to facilitate intubation in difficult situations. Recently, ultrasound-guided airway management has been used as a potential method to improve the intubation process. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Difficult Airway
- What is being tested?
- ultrasound guided bougie insertion and Conventional methods for bougie insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Sep 2024to 30 Apr 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults aged 15 -75 years.
- Elective surgical operation.
- ASA (American Society of Anesthesiologists) physical status I-III.
- Predicted difficult airway.
Who cannot join
- Emergency intubations.
- Patients with contraindications to the use of bougie.
- Patients with a known allergy to local anesthetics or ultrasound gel.
- Pregnancy.
- Craniofacial anomaly
- Patients with obstructive sleep apnea
- BMI > 35.
- Patient with gastroesophageal reflux disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculity of medicine - Al-Azhar University hospitals
Cairo, Cairo Governorate, 11884
About this study
Official title: Ultrasound-Guided Bougie Insertion Technique and Conventional Method in Difficult Intubation: A Randomized Controlled Study
Difficult airway management remains one of the biggest challenges in anesthesia practice. The Gum elastic bougie, an intubation tool, is frequently used to facilitate intubation in difficult situations. Recently, ultrasound-guided airway management has been used as a potential method to improve the intubation process. This study aims to compare the efficacy of ultrasound-guided bougie insertion with the conventional method regarding the duration of endotracheal tube (ETT) insertion and the number of attempts required in a difficult intubation population.
The goal of this clinical trial is to learn if using ultrasound during bougie insertion in difficult airway patients will improve the success rate and reduce the time of insertion. The main questions it aims to answer are:
Read more
Does using ultrasound reduce the number of insertion attempts? Does using ultrasound reduce the duration of bougie insertion?
Researchers will compare the ultrasound-guided technique to the conventional bougie insertion method. They will also assess both groups' hemodynamic parameters during and after the procedure and the success rate from the first trial.
- Conditions
- Difficult Airway
- Being tested
- ultrasound guided bougie insertion, Conventional methods for bougie insertion
- Keywords
- ultrasound, Difficult airways, Bougie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided bougie insertionProcedure or surgery
The anesthesiologist will use a high-frequency linear ultrasound probe at the level of the suprasternal notch to identify the tracheal rings. The probe will then be moved cephalad and placed over the cricothyroid membrane to visualize the vocal folds in the transverse view with the patient in the supine position. Using a C-mac laryngoscope, the intubator will assess the difficulty of visualization using the Cormack Lehan score; if the score is three or more, the bougie will be gently inserted with the curved tip anteriorly into the trachea and assess the real-time visualization of the bougie on the ultrasound screen as a linear echogenic structure moving through the hypoechoic lumen of the trachea then the tube will railed on the bougie and connected to the capnograph for endotracheal positioning confirmation when the square waveform will be maintained for five breaths.
Conventional methods for bougie insertionProcedure or surgery
The anesthesiologist will perform the bougie insertion using a C-mac laryngoscope, and he will assess the difficulty of visualization using the Cormack Lehan score; if the score is three or more, the bougie will be gently inserted with the curved tip anteriorly into the trachea while feeling the tracheal clicks as a sign of correct its placement, the intubator will advance it gently till feel resistance then withdraw 2-3 centimeters. If the depth of the bougie reaches 30 centimeters from the angle of the mouth without feeling the resistance, the bougie will be removed and reinserted. Then, the tube will be railed on the bougie and connected to the capnograph for endotracheal positioning confirmation when the square waveform is maintained for five breaths.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Ultrasound-guided bougie insertion | Active comparator | the ultrasound will be used to provide a real-life observation of the bougie advancement into the trachea to confirm its correct placement. Receives: Procedure: ultrasound guided bougie insertion |
| Group B: Conventional bougie insertion | Placebo comparator | using the conventional method for bougie insertion Receives: Procedure: Conventional methods for bougie insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of bougie insertion.
the time in seconds from the start of the bougie insertion to successful ETT placement
Measured: during the insertion of bougie
Number of attempts required for successful bougie insertion
As each separate insertion of the bougie: if the bougie cannot visualized by the ultrasound in (group A) OR if the depth of the bougie reaches 30 centimeters depth from the angle of the mouth without feeling the resistance in (group B), the bougie will be withdrawn and reinserted again.
Measured: during the insertion of bougie
Secondary outcomes (4)
Systolic and daistolic blood pressure changes during intubation
The systolic blood pressure in mmHg at T1, T2 and T3. The diastolic blood pressure in mmHg at T1, T2 and T3
Measured: T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
Success rate of the first attempt
Count the cases in which the insertion of bougie was confirmed from the first insertion trial.
Measured: during the insertion of bougie
Hemodynamic changes during intubation
The systolic blood pressure in mmHg at T1, T2 and T3. The diastolic blood pressure in mmHg at T1, T2 and T3 Heart rate per minute at T1, T2 and T3
Measured: T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
Heart rate during the procedure
The pulse rate per minute will be observed and documented at T1, T2 and T3
Measured: Pulse rate per minute T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start23 Sep 2024
- Primary completion30 Mar 2025
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Difficult AirwayStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammed Gaber Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Gaber Saad, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836388
- Sponsor's protocol ID
- Anesth-.0434/2024 Med research
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Huan C, Pan H, Fu S, Xu W, Gao Q, Wang X, Gao S, Chen C, Liu X. Characterization and evolution of the coronavirus porcine epidemic diarrhoea virus HLJBY isolated in China. Transbound Emerg Dis. 2020 Jan;67(1):65-79. doi: 10.1111/tbed.13321. Epub 2019 Aug 22.
PubMed 31381232Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.
PubMed 21345104Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
PubMed 29800096Kristensen MS. Ultrasonography in the management of the airway. Acta Anaesthesiol Scand. 2011 Nov;55(10):1155-73. doi: 10.1111/j.1399-6576.2011.02518.x. Epub 2011 Sep 7.
PubMed 22092121
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Bougie Insertion Technique and Conventional Method in Difficult Intubation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06836388
- Acronym / sponsor ID
- Anesth-.0434/2024 Med research
- Conditions
- Difficult Airway
- Keywords
- ultrasound, Difficult airways, Bougie
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mohammed Gaber SaadUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 20 Feb 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.
Difficult airway management remains one of the biggest challenges in anesthesia practice. The Gum elastic bougie, an intubation tool, is frequently used to facilitate intubation in difficult situations. Recently, ultrasound-guided airway management has been used as a potential method to improve the intubation process. This study aims to compare the efficacy of ultrasound-guided bougie insertion with the conventional method regarding the duration of endotracheal tube (ETT) insertion and the number of attempts required in a difficult intubation population.
The goal of this clinical trial is to learn if using ultrasound during bougie insertion in difficult airway patients will improve the success rate and reduce the time of insertion. The main questions it aims to answer are:
Does using ultrasound reduce the number of insertion attempts? Does using ultrasound reduce the duration of bougie insertion?
Researchers will compare the ultrasound-guided technique to the conventional bougie insertion method. They will also assess both groups' hemodynamic parameters during and after the procedure and the success rate from the first trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Ultrasound-guided bougie insertion | Active comparator | Procedure: ultrasound guided bougie insertionthe ultrasound will be used to provide a real-life observation of the bougie advancement into the trachea to confirm its correct placement. |
| Group B: Conventional bougie insertion | Placebo comparator | Procedure: Conventional methods for bougie insertionusing the conventional method for bougie insertion |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 15 -75 years.
- Elective surgical operation.
- ASA (American Society of Anesthesiologists) physical status I-III.
- Predicted difficult airway.
Key exclusion criteria (8 listed)
- Emergency intubations.
- Patients with contraindications to the use of bougie.
- Patients with a known allergy to local anesthetics or ultrasound gel.
- Pregnancy.
- Craniofacial anomaly
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 |
|---|---|---|
| ultrasound guided bougie insertionThe anesthesiologist will use a high-frequency linear ultrasound probe at the level of the suprasternal notch to identify the tracheal rings. The probe will then be moved cephalad and placed over the cricothyroid membrane to visualize the vocal folds in the transverse view with the patient in the supine position. Using a C-mac laryngoscope, the intubator will assess the difficulty of visualization using the Cormack Lehan score; if the score is three or more, the bougie will be gently inserted with the curved tip anteriorly into the trachea and assess the real-time visualization of the bougie on the ultrasound screen as a linear echogenic structure moving through the hypoechoic lumen of the trachea then the tube will railed on the bougie and connected to the capnograph for endotracheal positioning confirmation when the square waveform will be maintained for five breaths. | Procedure or surgery | Group A: Ultrasound-guided bougie insertion |
| Conventional methods for bougie insertionThe anesthesiologist will perform the bougie insertion using a C-mac laryngoscope, and he will assess the difficulty of visualization using the Cormack Lehan score; if the score is three or more, the bougie will be gently inserted with the curved tip anteriorly into the trachea while feeling the tracheal clicks as a sign of correct its placement, the intubator will advance it gently till feel resistance then withdraw 2-3 centimeters. If the depth of the bougie reaches 30 centimeters from the angle of the mouth without feeling the resistance, the bougie will be removed and reinserted. Then, the tube will be railed on the bougie and connected to the capnograph for endotracheal positioning confirmation when the square waveform is maintained for five breaths. | Procedure or surgery | Group B: Conventional bougie insertion |
Primary outcome
Duration of bougie insertion.
Time frame: during the insertion of bougie
the time in seconds from the start of the bougie insertion to successful ETT placement
Number of attempts required for successful bougie insertion
Time frame: during the insertion of bougie
As each separate insertion of the bougie: if the bougie cannot visualized by the ultrasound in (group A) OR if the depth of the bougie reaches 30 centimeters depth from the angle of the mouth without feeling the resistance in (group B), the bougie will be withdrawn and reinserted again.
4 secondary outcomes
Systolic and daistolic blood pressure changes during intubation
Time frame: T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
Success rate of the first attempt
Time frame: during the insertion of bougie
Hemodynamic changes during intubation
Time frame: T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
Heart rate during the procedure
Time frame: Pulse rate per minute T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
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 30 Apr 2025.
- Background: PubMed 31381232Huan C, Pan H, Fu S, Xu W, Gao Q, Wang X, Gao S, Chen C, Liu X. Characterization and evolution of the coronavirus porcine epidemic diarrhoea virus HLJBY isolated in China. Transbound Emerg Dis. 2020 Jan;67(1):65-79. doi: 10.1111/tbed.13321. Epub 2019 Aug 22.
- Background: PubMed 21345104Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.
- Background: PubMed 29800096Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.
- Background: PubMed 22092121Kristensen MS. Ultrasonography in the management of the airway. Acta Anaesthesiol Scand. 2011 Nov;55(10):1155-73. doi: 10.1111/j.1399-6576.2011.02518.x. Epub 2011 Sep 7.
- Individual participant dataSharing planned: Undecided
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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 ultrasound guided bougie insertion and Conventional methods for bougie insertion in people with Difficult Airway, run by Mohammed Gaber Saad 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 8 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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. Some participants in this study may receive a placebo. 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?
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?
Duration of bougie insertion. (time frame: during the insertion of bougie). The study lists 2 primary outcomes in all. 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 NCT06836388, which also lists 4 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 30 Apr 2025.