The primary objective is to quantify the overall success rate of intubation in prone position through an I-gel LMA.The secondary outcomes are time for insertion of the I-gel LMA, time for intubation, glottic view obtained by the VSSL, manoeuvres…
ID
Source
Brief title
Condition
- Other condition
- Lower respiratory tract disorders (excl obstruction and infection)
- Nervous system, skull and spine therapeutic procedures
Synonym
Health condition
Anesthesiologisch luchtwegmanagement
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall intubation success rate of VSSL use through the IILMA in subjects
in prone position.
Secondary outcome
Time for insertion of the I-gel LMA, time for intubation, glottic view obtained
by the VSSL, manoeuvres necessary for intubation, leakage of tidal volume by
ventilation through the I-gel LMA and the percentage of patients with
post-operative dysphonia and a sore throat on the recovery ward.
Background summary
Prone position ventilation is indicated in patients suffering from severe ARDS,
patients undergoing spine surgery and in out-of-hospital trauma scenes. When
accidental extubation occurs, there is a primary urge for ventilation since a
delay in ventilation causes hypoxia with possible fatal outcome.
One method to regain the ability for ventilation is to turn the patient to the
supine position and perform handbag ventilation, although this is time
consuming and sometimes impossible (during spine surgery). Another method is to
insert a LMA in prone position, and high success rate for ventilation are
achieved. Some patients, however, need to be intubated, because of the high
ventilation pressures, unfasted state or leakage of tidal volume. Inserting an
endotracheal tube through the LMA is the simplest method. However, success
rates are unknown and moreover, manoeuvres to increase this success rate have
not been investigated previously.
Some LMA*s, such as the FastTrach and the iLMA, are especially designed for
intubating through the LMA and high success rates are achieved. However,
successful insertion in prone position is limited with these devices. Since the
I-gel has a high success rate for ventilation in prone position, this device
could be the LMA of choice. However, intubating through the I-gel has lower
success rates in supine position. In prone position, this has not investigated
previously. Therefore, a study with intubation through the I-gel is necessary
to provide recommendations regarding this device.
One method to increase the intubation success rate is to use the VivaSight
Single Lumen tube (VVSL), which has a camera at the tip of tube. This allows to
alter the direction of the tube. The main disadvantage of this tube are the
required resources, such as the videoscreen, the availability of the tube and
the high costs compared to the simple Parker-tube. Therefore, this method is
likely to be unavailable in urgent situations. In this study, the view obtained
by the VVSL can be used to provide recommendations for manoeuvring the Parker
endotracheal tube.
Study objective
The primary objective is to quantify the overall success rate of intubation in
prone position through an I-gel LMA.
The secondary outcomes are time for insertion of the I-gel LMA, time for
intubation, glottic view obtained by the VSSL, manoeuvres necessary for
intubation, leakage of tidal volume by ventilation through the I-gel LMA and
the percentage of patients with post-operative dysphonia and a sore throat on
the recovery ward.
Study design
The study design is a prospective observational study.
Study burden and risks
The burden of this study is that participants have to endure extra pharyngeal
manoeuvres (up to three) which gives a slightly higher risk of a temporary sore
throat or temporary dysphonia. This manoeuvre happens under general anaesthesia.
There are no other burdens (e.g. questionnaires, additional site visits or
examinations).
There are no risks, since standard clinical safety measures are imbedded in
this study.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
all 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 fasted or diaphragm herniation.
- Professional voice usage.
- Unable to ventilate over the I-gel LMA in prone position
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL65936.098.18 |
OMON | NL-OMON23802 |