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NCT Number: NCT06836388

Using Ultrasound for Bougie Insertion in Difficult Airway Management

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Difficult Airway

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculity of medicine - Al-Azhar University hospitals

Cairo, Cairo Governorate, 11884, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ultrasound guided bougie insertion

Procedure

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 insertion

Procedure

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

    The systolic blood pressure in mmHg at T1, T2 and T3. The diastolic blood pressure in mmHg at T1, T2 and T3

  2. Success rate of the first attempt

    Time frame: during the insertion of bougie

    Count the cases in which the insertion of bougie was confirmed from the first insertion trial.

  3. 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

    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

  4. 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

    The pulse rate per minute will be observed and documented at T1, T2 and T3

Sponsors and collaborators

Lead sponsor

Mohammed Gaber Saad

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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