Airway Management
Conditions
Keywords
Airway Management, Extraglottic airway device, Laryngeal mask airway, Spritztube
Brief summary
The study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized adult patients. The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula. In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed. The investigators hypothesize that the LMA Supreme™ versus the Spritztube® tracheal cannula will similarly perform during anesthetized adult patients despite differences in their structural design.
Detailed description
A new extraglottic airway device, the Spritztube® \[tracheal cannula, Med Europe s.r.l\], was developed combining the ability to perform both EAD ventilation and oro-tracheal fibreoptic intubation using the same device. The Spritztube® consists of a silicone cannula with two low-pressure cuffs: a proximal cuff, designed to seal the pharynx cranially of the epiglottis and a distal cuff, designed to seal the oesophagus. The positioning of this device requires the aid of a spindle, that keep the cuffs on the same line and it is rigid enough to allow the passage through oropharynx tissue. That can be inserted blindly as extraglottic device or through the use of direct laryngoscopy or fibroscopy as tracheal cannula. The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula. In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.
Interventions
DEVICESpritztube®
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated
DEVICELMA Supreme™
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated
Sponsors
St. Bortolo Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
opening a sealed envelope, provided by an independent physician blinded to patient's allocation In addition, outcome assessor were blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anaesthesiologists (ASA) physical status classification I, II, and III; * Age \> 18 years * Elective surgery in the supine position
Exclusion criteria
* Pregnancy * Age \<18 years * Not eligibility for surgery * Predicted difficult airway management * Positive history for esophageal or pharyngeal diseases * Emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the successful placement of device in two groups | Intraoperative | A successful intubation attempt was recognized if the breathing circuit was connected, the breath sounds over the lung were present and the End tidal CO2 trace was revealed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion time (in seconds) | Intraoperative | The insertion time was measured from the insertion of device into the patient's mouth to connecting the breathing circuit. |
| Number of attempts | Intraoperative | If placement had failed after three attempts, the study was abandoned and the airway was maintained through a tracheal tube. |
| Easy to insert | Intraoperative | A successful insertion of device in just one attempt |
| number of complications at insertion | Intraoperative | air leak at induction, laryngospasm, obstruction after induction, gastric insufflation, failure device |
| number of complications at removal | Postoperative | dysphagia, hoarseness and sore throat |
Outcome results
None listed