Clinical trial NCT05680909: Evaluation of SaCo Videolaryngeal Mask Airway in Morbidly Obese
Official title: Evaluation of SaCo Videolaryngeal Mask Airway for Airway Management and Intubation in Morbidly Obese Anesthetized for Elective Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Airway Complication of Anesthesia
Intubation Complication
Intubation; Difficult or Failed
Keywords: morbid obesity
endotracheal intubation
laryngeal mask airway
airway management
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: morbidly obese patients scheduled for elective bariatric procedure

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* morbid obesity defined as BMI\>40 kg/m2
* scheduled for elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* lack of conscent
* airway abnormalities like for example tumors in mouth, tongue, airway injury,
* surgery on airway,
* emergency surgery,

Primary outcomes:
measure: effectiveness of insertion of SaCo VLM for airway management in morbidly obese
timeFrame: immediate - right after performing insertion of SaCo mask
measure: effectiveness of ventillation using SaCo mask in morbidly obese
timeFrame: immediate - right after insertion of SaCo mask
measure: effectiveness of visualisation of larynx using SaCo VLM in morbidly obese
timeFrame: immediate - right after insertion of SaCo VLM
measure: seal pressure of SaCo VLM in morbidly obese
timeFrame: immediate - right after insertion of SaCo VLM
Secondary outcomes:
measure: effectiveness of SaCo VLM for endotracheal intubation in morbidly obese
timeFrame: immediate - right after endotracheal intubation through SaCo mask
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Medical University of Lodz, Poland
Study officials:
affiliation: Medical University of Lodz, Poland
name: Tomasz Gaszynski, Prof
role: PRINCIPAL_INVESTIGATOR
References: