Using Ultrasound for Bougie Insertion in Difficult Airway Management

Not Applicable

Active, not recruiting

• Conditions: Difficult Airway

• Registration Number: NCT06836388
• Lead Sponsor: Mohammed Gaber Saad

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-23
• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-20
• Primary Completion: 2025-03-30
• Last Update Submitted: 2025-04-28
• Study Completion: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of bougie insertion.	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	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 Outcome Measures

Name	Time	Method
Heart rate during the procedure	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
Systolic and daistolic blood pressure changes during intubation	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
Success rate of the first attempt	during the insertion of bougie	Count the cases in which the insertion of bougie was confirmed from the first insertion trial.
Hemodynamic changes during intubation	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

Trial Locations

Locations (1)

Faculity of medicine - Al-Azhar University hospitals; 🇪🇬 Cairo, Egypt