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Using Ultrasound for Bougie Insertion in Difficult Airway Management

Ultrasound-Guided Bougie Insertion Technique and Conventional Method in Difficult Intubation: A Randomized Controlled Study

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06836388
Enrollment
100
Registered
2025-02-20
Start date
2024-09-23
Completion date
2025-04-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Airway

Keywords

ultrasound, Difficult airways, Bougie

Brief 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. 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.

Interventions

PROCEDUREultrasound guided 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.

PROCEDUREConventional methods for bougie insertion

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.

Sponsors

Mohammed Gaber Saad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Adults aged 15 -75 years. * Elective surgical operation. * ASA (American Society of Anesthesiologists) physical status I-III. * Predicted difficult airway.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of bougie insertion.during the insertion of bougiethe time in seconds from the start of the bougie insertion to successful ETT placement
Number of attempts required for successful bougie insertionduring the insertion of bougieAs 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.

Secondary

MeasureTime frameDescription
Systolic and daistolic blood pressure changes during intubationT1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmationThe systolic blood pressure in mmHg at T1, T2 and T3. The diastolic blood pressure in mmHg at T1, T2 and T3
Success rate of the first attemptduring the insertion of bougieCount the cases in which the insertion of bougie was confirmed from the first insertion trial.
Hemodynamic changes during intubationT1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmationThe 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
Heart rate during the procedurePulse rate per minute T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmationThe pulse rate per minute will be observed and documented at T1, T2 and T3

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026