Difficult IntubationNCT04311775
Laryngeal Mask, Video Laryngoscopy
An observational study of Difficult Intubation, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA insertion technique was defined when it was first produced by Archie Brain . Accordingly, it is recommended to advance the device to the level where resistance is felt blindly. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation
- What is being tested?
- larengeal mask insertion with video laryngoscopy and laryngeal mask insertion
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2021to 27 Feb 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA1,2,3 group patients to insertion of laryngeal mask
Who may be able to join
- Patients between 18-65 years old
- ASA1,2,3 group patients
- Patients undergoing general anesthesia Patients scheduled for elective surgery
Who cannot join
- The patient's refusal to participate in the study
- Contraindication for placement of the laryngeal mask
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Video Laryngoscope in Laryngeal Mask Placement
LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA insertion technique was defined when it was first produced by Archie Brain . Accordingly, it is recommended to advance the device to the level where resistance is felt blindly. However, placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation. To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies . Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.
Read the detailed description
LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA insertion technique was defined when it was first produced by Archie Brain . Accordingly, it is recommended to advance the device to the level where resistance is felt blindly. However, placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation. To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies . Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.In cases where difficulties are found in laryngeal mask placement, using direct laryngoscope or videosingoscope, placement is frequently applied in anesthesia practice. Kim GW et al investigated LMA placement with direct laryngoscope. However, there is no study investigating the effectiveness of videongoscopes. Videoingoscopes have wide viewing angles through their cameras located at the blade tips. For this reason, we think that it will be advantageous in placing a laryngeal mask.
- Conditions
- Difficult Intubation
- Being tested
- larengeal mask insertion with video laryngoscopy, laryngeal mask insertion
- Keywords
- laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
larengeal mask insertion with video laryngoscopyDevice
it is a method of inserting a laryngeal mask into the airway with videolaryngoscopy
laryngeal mask insertionOther
laryngeal mask is a method of inserting atube into the upper airway
| Study group | Role | What they receive |
|---|---|---|
| video laryngoscopy | video laryngoscope is a camera laryngoscope system used to see the larynx with camera Receives: Device: larengeal mask insertion with video laryngoscopy | |
| laryngoscopy | laryngoscopy is a method used to see the larynx. Receives: Other: laryngeal mask insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The role of Videeolaryngoscope in Placement of Laryngeal Mask
video laryngoscopy use in Larengeal Mask insertion, prevent complications of Larengeal mask.
Measured: the study will comlete in two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start20 Jan 2021
- Primary completion20 Feb 2021
- Study completion27 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tahsin Şimşek, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311775
- Sponsor's protocol ID
- 2019/514/150/21
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2020
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Video Laryngoscope in Laryngeal Mask Placement
- ClinicalTrials.gov ID
- NCT04311775
- Acronym / sponsor ID
- 2019/514/150/21
- Conditions
- Difficult Intubation
- Keywords
- laryngeal mask
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Feb 2021 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 17 Mar 2020 (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.
LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA insertion technique was defined when it was first produced by Archie Brain . Accordingly, it is recommended to advance the device to the level where resistance is felt blindly. However, placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation. To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies . Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.
Detailed description
LMA insertion provide an intact airway for many surgeries during general anesthesia . LMA insertion technique was defined when it was first produced by Archie Brain . Accordingly, it is recommended to advance the device to the level where resistance is felt blindly. However, placing LMA may not always be smooth and uncomplicated. Thus, gas leaks may occur and intragastric pressure increase may occur due to gastric insufflation. To overcome these difficulties, the placement of the LMA under direct vision using a laryngoscope has been described in several studies . Previous studies have shown that the reliability of the laryngeal mask can be demonstrated by the oropharyngeal cuff leak test . In addition, the classification of the image of the laryngeal structures mediated by fiberoptic imaging and vocal cords from the LMA gives us information about the availability of effective positive pressure ventilation.In cases where difficulties are found in laryngeal mask placement, using direct laryngoscope or videosingoscope, placement is frequently applied in anesthesia practice. Kim GW et al investigated LMA placement with direct laryngoscope. However, there is no study investigating the effectiveness of videongoscopes. Videoingoscopes have wide viewing angles through their cameras located at the blade tips. For this reason, we think that it will be advantageous in placing a laryngeal mask.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video laryngoscopy | – | Device: larengeal mask insertion with video laryngoscopyvideo laryngoscope is a camera laryngoscope system used to see the larynx with camera |
| laryngoscopy | – | Other: laryngeal mask insertionlaryngoscopy is a method used to see the larynx. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA1,2,3 group patients to insertion of laryngeal mask
Key inclusion criteria (3 listed)
- Patients between 18-65 years old
- ASA1,2,3 group patients
- Patients undergoing general anesthesia Patients scheduled for elective surgery
Key exclusion criteria (2 listed)
- The patient's refusal to participate in the study
- Contraindication for placement of the laryngeal mask
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| larengeal mask insertion with video laryngoscopyit is a method of inserting a laryngeal mask into the airway with videolaryngoscopy | Device | video laryngoscopy |
| laryngeal mask insertionlaryngeal mask is a method of inserting atube into the upper airway | Other | laryngoscopy |
Primary outcome
The role of Videeolaryngoscope in Placement of Laryngeal Mask
Time frame: the study will comlete in two month
video laryngoscopy use in Larengeal Mask insertion, prevent complications of Larengeal mask.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Difficult Intubation, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 24 Aug 2021. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The role of Videeolaryngoscope in Placement of Laryngeal Mask (time frame: the study will comlete in two month). 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 24 Aug 2021.