No registrations found.
ID
Source
Health condition
laryngeal mask airway, intubation, prone position
Sponsors and support
Intervention
Outcome measures
Primary outcome
Succesrate of tracheal intubation
Secondary outcome
, time for insertion of the I-gel LMA (seconds), time for intubation (seconds), glottic view obtained by the VSSL (description according to modified Cormack Lehane criteria from Gaitini: grade 1: full view of the arytenoids and glottis; grade 2: epiglottis, arytenoids or glottic opening are partly visible, the structure of cords is difficult to see; grade 3: dark areas indicating an open space; and grade 4: no part of the larynx can be identified)9, manoeuvres necessary for intubation (descriptive), leakage of tidal volume by ventilation through the I-gel LMA (millilitres) and the percentage of patients with post-operative dysphonia and a sore throat on the recovery ward.
Background summary
To be announced.
Study objective
We hypothesize a successrate lower than 70%
Study design
aug-2018: approval of METC
Jan-2018: start study
31-8-2019: Study ended prematurely for unable to achieve the primary outcome.
Intervention
The patient will receive general anesthesia in prone position and an I-gel LMA will be inserted, as is the normal clinical practice. The intervention will be an onscreen intubation of a VivaSight Single Lumen (VSSL) tube through I-gel LMA. This will consist of three attempts of intubation, all of which will be visualized by another person to limit the possibility for damage. As soon as tracheal intubation is achieved, further attempts will not be performed and the interventions for the purpose of the study will be ended.
Inclusion criteria
Inclusion criteria are patients scheduled for short-lasting (< 1 hour) elective spinal surgery.
Exclusion criteria
- Body mass index above 32.
- Edentulous state.
- Mouth opening of less than 3 centimeters.
- Aspiration risk due to not being sober or diaphragm herniation.
- Professional voice usage.
- Unable to ventilate over the I-gel LMA in prone position.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6387 |
| NTR-old | NTR7659 |
| CCMO | NL65936.098.18 |
| OMON | NL-OMON46187 |