An interventional study of ultrasound guided bougie insertion and Conventional methods for bougie insertion in Difficult Airway, sponsored by Mohammed Gaber Saad. Active, not recruiting at 1 site in Egypt. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Mohammed Gaber Saad · Not applicable, Interventional, and Treatment
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.
Mohammed Gaber Saad is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the ultrasound will be used to provide a real-life observation of the bougie advancement into the trachea to confirm its correct placement.
Procedure: ultrasound guided bougie insertion
using the conventional method for bougie insertion
Procedure: Conventional methods for bougie insertion
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.
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.
Duration of bougie insertion.
the time in seconds from the start of the bougie insertion to successful ETT placement
Time frame: 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.
Time frame: during the insertion of bougie
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
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
Count the cases in which the insertion of bougie was confirmed from the first insertion trial.
Time frame: 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
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
The pulse rate per minute will be observed and documented at T1, T2 and T3
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
Plan to share: Undecided
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Mohammed Gaber Saad