None listed
Conditions
Brief summary
An endotracheal tube (ETT) is used to safely and securely manage a patient's airway during anaesthesia. Sometimes these can be difficult to insert, requiring the use of an introducer - something smaller and solid that fits inside the ETT, and is easier to insert into the trachea ('wind pipe') than the tube initially. One of the problems that exists with this technique is that any gap between the ETT and the introducer can lead to the ETT getting caught on structures around the vocal cords as it is railroaded over the introducer. Our study uses a novel ETT/guidewire system that was developed to overcome these problems. The ETT has a channel for the guidewire in its wall, and the rate of deformation of the ETT matches the rate of deformation of the guidewire. This allows the ETT to follow the path of the guidewire easily. We will use an accepted technique of visualising the vocal cords (using a video laryngoscope) to pass the guidewire into the 'wind pipe', and then railroad the ETT over the guidewire under vision. Our hypothesis is that this system will have a very low rate of ETT hold-up or impingement on entering the 'wind pipe', and therefore provide reliable and atraumatic intubation. We will record the incidence of all complications, including trauma to any airway structures, misplacement of the tube, difficulty placing the tube in the 'wind pipe', problems with oxygen levels during the procedure, and the time taken for the procedure. We expect the system to be very effective and reliable, based on preliminary studies on manikins and cadavers, and also based on one human study done overseas using this system.
Interventions
Assessment of a new wire-guided endotracheal tube (ETT).
Our hypothesis is that this device will provide reproducible railroading of the ETT over the guidewire, with minimal hold-up and a very low rate of endotracheal tube impingement on entering the glottic inlet. This will therefore provide reliable and atraumatic endotracheal intubation.
This ETT is designed to have the same rate of deformation as the guidewire over which it will be passed, with the channel for the guidewire located within th
Assessment of a new wire-guided endotracheal tube (ETT). Our hypothesis is that this device will provide reproducible railroading of the ETT over the guidewire, with minimal hold-up and a very low rate of endotracheal tube impingement on entering the glottic inlet. This will therefore provide reliable and atraumatic endotracheal intubation. This ETT is designed to have the same rate of deformation as the guidewire over which it will be passed, with the channel for the guidewire located within the wall of the ETT. Traditional introducers/bougies are passed through the glottic inlet, and then an ETT is passed (railroaded) over the introducer. This is a standard (and commonly used) technique in anaesthesia practice, however it has its drawbacks - namely there is often a gap between the introducer and the ETT due to differences in the diameters of the introducer and the ETT lumen. This can result in the ETT catching on laryngeal (or other) structures during the railroading process, and potentially results in tissue trauma. The non-kinking guidewire in this new system acts as an introducer, but the design reduces issues relating to the gap between traditional 'introducers/bougies' and the ETT. We hypothesise that this, along with the ETT's soft silicone tip, will help to minimise ETT 'hold-up' and tissue trauma. Additionally, because the rate of deformation of the ETT matches the rate of deformation of the guidewire we also hypothesise that it will reduce the risk of ETT misplacement. The system (ETT and guidewire) will be used in patients who require an endotracheal tube for their surgery. The procedure will involve using a Karl Storz C-Mac D-blade to insert an adequate length of the guidewire in the trachea, and then railroading the ETT from the oropharynx (under vision) into the trachea, and confirming correct placement via standard methods. The study will be conducted at Royal Hobart Hospital by a small group of consultant anaesthetists, with recruitment of 300 patients expected to take approximately 2 years. Elective surgery patients will be screened on upcoming operating lists and recruited on lists involving the study anaesthetists (investigators). With regard to "strategies used to assess or monitor fidelity...[of]...the intervention", we have a departmental research nurse who will be involved in observing the procedures and in data collection. Apart from following the study protocol and recording the information on a specific Case Record Form for each procedure, there are no other specific strategies relaying to this.
Sponsors
Dr Michael Challis
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- ASA 1 –3; - older than 18 years of age; - fasted at least 6 hours for solids and 2 hours for clear liquids; - undergoing elective procedures requiring endotracheal intubation with an expected easy intubation.
Exclusion criteria
- predicted difficult intubation; - predicted difficult bag-mask ventilation; - morbid obesity (BMI> 35); - significant pulmonary disease; - decreased cervical spine mobility; - known pathology or previous major surgery in the mouth, pharynx or larynx; - patients where a ‘rapid sequence’ or ‘modified rapid sequence’ induction is deemed clinically appropriate.
Outcome results
None listed