Using Ultrasound for Bougie Insertion in Difficult Airway Management

NCT06836388 | Active Not Recruiting

• 1 other identifier: Anesth-.0434/2024 Med research
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Airway

Keywords

ultrasound; Difficult airways; Bougie

Outcome Measures

Primary Outcomes (2)

• Duration of bougie insertion.

  the time in seconds from the start of the bougie insertion to successful ETT placement

  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30 centimeters depth from the angle of the mouth without feeling the resistance in (group B), the bougie will be withdrawn and reinserted again.

  during the insertion of bougie

Secondary Outcomes (4)

• 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

• Success rate of the first attempt

  during the insertion of bougie

• 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

• 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

Study Arms (2)

Group A: Ultrasound-guided bougie insertion

ACTIVE COMPARATOR

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

Group B: Conventional bougie insertion

PLACEBO COMPARATOR

using the conventional method for bougie insertion

Procedure: Conventional methods for bougie insertion

Interventions

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.

Group A: Ultrasound-guided bougie insertion

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.

Group B: Conventional bougie insertion

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohammed Gaber Saad: lead

Study Sites (1)

Faculity of medicine - Al-Azhar University hospitals

Cairo, Cairo Governorate, 11884, Egypt

Location

Related Publications (4)

• Huan C, Pan H, Fu S, Xu W, Gao Q, Wang X, Gao S, Chen C, Liu X. Characterization and evolution of the coronavirus porcine epidemic diarrhoea virus HLJBY isolated in China. Transbound Emerg Dis. 2020 Jan;67(1):65-79. doi: 10.1111/tbed.13321. Epub 2019 Aug 22.

  PMID: 31381232 BACKGROUND

• Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.

  PMID: 21345104 BACKGROUND

• Driver BE, Prekker ME, Klein LR, Reardon RF, Miner JR, Fagerstrom ET, Cleghorn MR, McGill JW, Cole JB. Effect of Use of a Bougie vs Endotracheal Tube and Stylet on First-Attempt Intubation Success Among Patients With Difficult Airways Undergoing Emergency Intubation: A Randomized Clinical Trial. JAMA. 2018 Jun 5;319(21):2179-2189. doi: 10.1001/jama.2018.6496.

  PMID: 29800096 BACKGROUND

• Kristensen MS. Ultrasonography in the management of the airway. Acta Anaesthesiol Scand. 2011 Nov;55(10):1155-73. doi: 10.1111/j.1399-6576.2011.02518.x. Epub 2011 Sep 7.

  PMID: 22092121 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lcturer of anesthesia, intensive care and pain medicine

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 20, 2025
• Study Start: September 23, 2024
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-01

Locations

EG (1)