Evaluation of SaCo Videolaryngeal Mask Airway in Morbidly Obese

NCT ID: NCT05680909

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2023-08-01

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.

Conditions

Morbid Obesity; Airway Complication of Anesthesia; Intubation Complication; Intubation; Difficult or Failed

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

SaCo VLM evaluation

Prospective group of morbidly obese patients scheduled for elective bariatric procedure with the use of SaCo VLM for airway management.

The following features related to SoCo VLM use will be recorded: insertion of SaCo VLM, evaluation of ventilation parameters, attempt of endotracheal intubation via SaCo VLM's lumen under continuouis visualisation of entrance to larynx using videoscope intergatred system

No interventions assigned to this group

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomasz Gaszynski, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz, Poland

Locations

Medical University of Lodz, Poland

Lodz, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Tomasz Gaszynski, Prof

Role: CONTACT

tomasz.gaszynski@umed.lodz.pl

+48 42 6783748

Facility Contacts

Tomasz Gaszynski, professor

Role: primary

tomasz.gaszynski@umed.lodz.pl

Other Identifiers

RNN/104/22/KB

Identifier Type: -

Identifier Source: org_study_id