Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05680909 |
| Other study ID # |
RNN/104/22/KB |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 20, 2022 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
January 2023 |
| Source |
Medical University of Lodz |
| Contact |
Tomasz Gaszynski, Prof |
| Phone |
+48 42 6783748 |
| Email |
tomasz.gaszynski[@]umed.lodz.pl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
SaCo videolaryngeal mask airway is a novel third generation supraglottic device allowing for
continuous observation of entrance to larynx via inserted in special channel videoscope
connected with cable with external monitor. In obese patients airway management can be
difficult so use of new devices that improve safety and potentially efficacy of airway
management is indicated. In prospective observational study the SaCo VLM will be evaluated in
terms of maintaining airway patency and effectiveness of intubation through it's lumen in
morbidly obese scheduled for elective general surgery under general anesthesia.
Description:
Morbidly obese patients pose challenge to operator when airway management is needed.
Additionally they are at increased risk of complications related to failed airway management,
hypoxia and following brain injury. SaCo videolaryngeal mask airway is a nowvel third
generation supraglottic device allowing for continuous observation of entrance to larynx via
inserted in special channel videoscope connected with cable with external monitor. In obese
patients airway management can be difficult so use of new devices that improve safety and
potentially efficacy of airway management is indicated.
In prospective observational study the SaCo VLM will be evaluated in terms of maintaining
airway patency and effectiveness of intubation through it's lumen in morbidly obese scheduled
for elective general surgery under general anesthesia.
After induction to general anesthesia SaCo VLM will be inserted with continuous visualisation
through camera channel and inserted videoscope and mechanical ventilation will be commenced.
Ease of SaCo VLM insertion will be recorded in 5 grade scale: 1- very easy, 2- easy, 3-
neutral, 4 - difficult, 5 - very difficult. Time of insertion will be recorded as time from
grabbing device and opening of patient's mouth to connecting SaCo VLM to ventilator and
confirming of patient's ventilation. Parameters of mechanical ventilation will be recorded:
Peak pressure, Lung Compliance - from respirator monitoring system and Seal pressure
(measured with following method: fresh gas flow 5 l/min, valve set at 40cmH2O,
manual/spontaneuous ventilation mode - with increasing airway pressure when the leak will be
recognized achieved maximum pressure will be recorded). The visualisation of entrance to
larynx will be assessed on device's monitor in 4-grade scale: 1- best view - all structures
of vocal cords visible, 2 - vocal cords partialy visible, 3 - only lower part of entrance to
larynx visible, 4 - no visualisation of entrance to larynx). Necessary adjustements will be
reorded like external pressure on thyroid cartilage, changing of SaCo VLM mask position. In
case of not adequate ventilation following steps will be taken: reposition of SaCo VLM,
changing of size of SaCo VLM, endotracheal intubation using videolaryngoscope. After
measurements the endotracheal intubation efforts will be commensed under continuous
visualisation of entrance to larynx with SaCo VLM videoscope system. Time of intubation will
be recorded. Ease of intubation will be recorded in 5 grade scale: 1- very easy, 2- easy, 3-
neutral, 4 - difficult, 5 - very difficult. After successful endotracheal intubation
confirmed with EtCO2 the standard general anesthesia will continue. After surgery and
anesthesia the possible complications will be evaluated: track of blood on device,
laryngospasm, sore throat.
