Intubating Condition
Conditions
Keywords
USB, cervical immobilization, rigid collar
Brief summary
In patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of availability, need for expertise in the use, difficulty with non-cooperative patients, or presence of blood or secretions in the airway. Two devices are commonly used to facilitate tracheal intubation: a stylet or a tracheal tube introducer (bougie).
Detailed description
The Universal Stylet Bougie, or USB™, represents a significant advance in the design and development of tracheal introducers (bougies) and stylets. Traditionally, the design requirements of styles and bougies have always been considered incompatible. A stylet requires sufficient rigidity to allow the tracheal tube to be manipulated to a variety of angles, whereas a bougie needs to be flexible enough to allow positive tracheal ring feedback to allow correct placement. The unique design of the USB™ means the device can be used as a stylet or as a bougie. It consists of two metals inserted on both sides and a flexible middle section. The USB can easily be manipulated to a variety of angles when used as a stylet, yet has the flexibility when used as a bougie. In addition, the hexagonal shape provides less contact with the inner surface of the tracheal tube, providing particularly easy insertion and removal. In this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar. Subsequently, we will assess whether using the USB device could improve the successful rate of intubation in these patients.
Interventions
DEVICEUSB as a stylet
USB used as a bougie
DEVICEUSB as a bougie
USB used as a bougie
Sponsors
Theodor Bilharz Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
the investigator responsible for data collection and the patients participating in the study will not be aware of the group assignment.
Intervention model description
Patients will be allocated, according to the study group into: 1. Bougie Group: (Group A) Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie. 2. Stylet Group: ( Group B) Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet. 3. Control Group: (Group C) Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. ASA (American society of Anesthesiologists) physical status 1-2. 2. Age 18- 60 years old of both sexes. 3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.
Exclusion criteria
1. Age \< 18 years and ≥ 60 years 2. Pregnancy 3. Patients with BMI \>35 kg m-2 4. Emergency surgery or full stomach 5. Patients with suspected difficult airway {e.g., high neck circumference, airway masses, mouth scars, neck scars, or history of snoring). 6. Patients with cervical spine pathology 7. Patients with any cardiac disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time required for intubation. | 30 seconds - 2 minutes |
Secondary
| Measure | Time frame |
|---|---|
| number of attempts | 30 seconds to 2 minutes |
Countries
Egypt
Outcome results
None listed