Using Ultrasound for Bougie Insertion in Difficult Airway Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Difficult Airway

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A: Ultrasound-guided bougie insertion

the ultrasound will be used to provide a real-life observation of the bougie advancement into the trachea to confirm its correct placement.

Group Type ACTIVE_COMPARATOR

ultrasound guided bougie insertion

Intervention Type 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.

Group B: Conventional bougie insertion

using the conventional method for bougie insertion

Group Type PLACEBO_COMPARATOR

Conventional methods for bougie insertion

Intervention Type 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.

Interventions

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ultrasound 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.

Intervention Type PROCEDURE

Conventional 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No