Morbid ObesityNCT05680909
Evaluation of SaCo Videolaryngeal Mask Airway in Morbidly Obese
An observational study of Morbid Obesity and Airway Complication of Anesthesia, run by Medical University of Lodz at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Airway Complication of Anesthesia, Intubation Complication
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 20 May 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: morbidly obese patients scheduled for elective bariatric procedure
Who may be able to join
- morbid obesity defined as BMI>40 kg/m2
- scheduled for elective surgery under general anesthesia with endotracheal intubation
Who cannot join
- lack of conscent
- airway abnormalities like for example tumors in mouth, tongue, airway injury,
- surgery on airway,
- emergency surgery,
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Lodz, Poland
Lodz, 90-153
Tomasz Gaszynski, professor, tomasz.gaszynski@umed.lodz.pl
Tomasz Gaszynski, MD PhD
About this study
Official title: Evaluation of SaCo Videolaryngeal Mask Airway for Airway Management and Intubation in Morbidly Obese Anesthetized for Elective Surgery.
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.
Read the 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
- Keywords
- morbid obesity, endotracheal intubation, laryngeal mask airway, airway management
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of insertion of SaCo VLM for airway management in morbidly obese
evaluation of insertion effectiveness: proper insertion confirmend by presence of EtCO2
Measured: immediate - right after performing insertion of SaCo mask
effectiveness of ventillation using SaCo mask in morbidly obese
evaluation of ventillation effectiveness indicated by proper ventilation parameters
Measured: immediate - right after insertion of SaCo mask
effectiveness of visualisation of larynx using SaCo VLM in morbidly obese
visualisation of entrance to larynx with intergrated SaCo VLM videoscope system - evaluated in 4 grade scale: 1 - best visualisation - all structures of entrance to larynx visible, 4 - only epiglottis visible
Measured: immediate - right after insertion of SaCo VLM
seal pressure of SaCo VLM in morbidly obese
seal pressure - measured on anesthesia machine
Measured: immediate - right after insertion of SaCo VLM
Secondary outcomes (1)
effectiveness of SaCo VLM for endotracheal intubation in morbidly obese
evaluation of endotracheal intubation through SaCo VLM lumen: intubation confirmed by proper positioning of tube visible on monitor of device and confirmed by proper ventilation and presence of EtCO2; evaluation of easiness of ET insetion - if additional maneouvers were necessary like external pressure on thyroid cartilage.
Measured: immediate - right after endotracheal intubation through SaCo mask
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start20 May 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tomasz Gaszynski, Prof, Principal investigator, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680909
- Sponsor's protocol ID
- RNN/104/22/KB
- Status last verified
- Jan 2023
- First submitted
- 18 Jul 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SaCo Videolaryngeal Mask Airway for Airway Management and Intubation in Morbidly Obese Anesthetized for Elective Surgery.
- ClinicalTrials.gov ID
- NCT05680909
- Acronym / sponsor ID
- RNN/104/22/KB
- Conditions
- Morbid Obesity, Airway Complication of Anesthesia, Intubation Complication, Intubation; Difficult or Failed
- Keywords
- morbid obesity, endotracheal intubation, laryngeal mask airway, airway management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- morbidly obese patients scheduled for elective bariatric procedure
Key inclusion criteria (2 listed)
- morbid obesity defined as BMI>40 kg/m2
- scheduled for elective surgery under general anesthesia with endotracheal intubation
Key exclusion criteria (4 listed)
- lack of conscent
- airway abnormalities like for example tumors in mouth, tongue, airway injury,
- surgery on airway,
- emergency surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effectiveness of insertion of SaCo VLM for airway management in morbidly obese
Time frame: immediate - right after performing insertion of SaCo mask
evaluation of insertion effectiveness: proper insertion confirmend by presence of EtCO2
effectiveness of ventillation using SaCo mask in morbidly obese
Time frame: immediate - right after insertion of SaCo mask
evaluation of ventillation effectiveness indicated by proper ventilation parameters
effectiveness of visualisation of larynx using SaCo VLM in morbidly obese
Time frame: immediate - right after insertion of SaCo VLM
visualisation of entrance to larynx with intergrated SaCo VLM videoscope system - evaluated in 4 grade scale: 1 - best visualisation - all structures of entrance to larynx visible, 4 - only epiglottis visible
seal pressure of SaCo VLM in morbidly obese
Time frame: immediate - right after insertion of SaCo VLM
seal pressure - measured on anesthesia machine
1 secondary outcome
effectiveness of SaCo VLM for endotracheal intubation in morbidly obese
Time frame: immediate - right after endotracheal intubation through SaCo mask
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Gaszynski, Prof principal investigator
Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Airway Complication of Anesthesia, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Gaszynski, Prof (+48 42 6783748, tomasz.gaszynski@umed.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of insertion of SaCo VLM for airway management in morbidly obese (time frame: immediate - right after performing insertion of SaCo mask). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.