Clinical trial NCT06836388: Using Ultrasound for Bougie Insertion in Difficult Airway Management
Official title: Ultrasound-Guided Bougie Insertion Technique and Conventional Method in Difficult Intubation: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Difficult Airway
Keywords: ultrasound
Difficult airways
Bougie
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Duration of bougie insertion.
timeFrame: during the insertion of bougie
measure: Number of attempts required for successful bougie insertion
timeFrame: during the insertion of bougie
Secondary outcomes:
measure: Systolic and daistolic blood pressure changes during intubation
timeFrame: T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
measure: Success rate of the first attempt
timeFrame: during the insertion of bougie
measure: Hemodynamic changes during intubation
timeFrame: T1: 5 minutes before induction of anesthesia. T2: 5 minutes after tube positioning confirmation. T3:15 minutes after tube positioning confirmation
measure: Heart rate during the procedure
timeFrame: 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
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculity of medicine - Al-Azhar University hospitals
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.