Airway Complication of AnesthesiaNCT05430425
Comparison of the Efficiency of Classical and I-GEL LMAs Selected by Different Methods in Providing a Safe Airway
An observational study of Airway Complication of Anesthesia, run by Yunus Emre.
Trial summary
In recent years, the use of laryngeal masks has been increasing in operating room and non-operating room anesthesia applications. Patients with inappropriate LMA may develop high leakages, gastric distension and inadequate ventilation during ventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- respiratory safety
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2022to 22 Oct 2022
- 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: Cases aged between 18-65 years, whose elective consents have been obtained, and who will be placed under ASA I-II and LMA under general anesthesia will be included.
Who may be able to join
- Elective cases between the ages of 18-65,
- ASA I-II,
- who will be fitted with an LMA by the anesthesia clinic,
- and whose consent has been obtained
Who cannot join
- ->65 years old,
- excessive cachectic or body mass index (BMI) >30 kg/m2,
- those with high risk of regurgitation or aspiration (large hiatal hernia, Zenker's diverticulum, scleroderma, pregnancy, history of gastroesophageal reflux disease, uncontrolled diabetes mellitus and obesity),
- potentially difficult airway (history of airway difficulty, mouth opening <2 cm,
- Mallampati class 4,
- limited neck extension or cervical spine pathology),
Show all 10Show fewer
- airway pathology,
- decreased presence of pulmonary or chest wall compliance,
- preoperative sore throat,
- planned operation Patients with a duration of >2 hours and who need a prone position during surgery will not be included in the study.
About this study
In recent years, the use of laryngeal masks has been increasing in operating room and non-operating room anesthesia applications. Patients with inappropriate LMA may develop high leakages, gastric distension and inadequate ventilation during ventilation. If the laryngeal masks used to provide a safe airway in the patient are not selected in the appropriate size, adequate ventilation may not be provided, which may lead to various complications such as increased morbidity and mortality. In order to prevent and predict the bad results that may occur, we foresee which method can be chosen more appropriately for the patients and will guide the clinicians.
Read the detailed description
The laryngeal mask (LMA) is a subragglottic airway device commonly used to provide lung ventilation during general anesthesia. In this study, we aimed to compare the efficacy of classical and I-GEL LMA selected with different techniques.
Successful placement of the Laryngeal Mask Airway (LMA) largely depends on the correct size selection.
The size of the laryngeal mask airway is usually determined by the weight of the patient. However, in some cases an alternative method can be used. The weight of the patient is sometimes unknown (eg, obese, malnourished, sedentary or unconscious patients) and can be unpredictable, especially in children. Therefore, it will be useful to have alternative ways (according to 1. body weight, 2. thyromental distance, 3. dimensioning with three fingers) in determining the appropriate size of the laryngeal mask size. These different methods should be simple to perform and easy to remember.
LMA is increasingly used in elective surgery, resuscitation, difficult airway and emergency situations. Successful use of the LMA largely depends on the correct size selection, method of insertion, and cuff sealing. Placing an improperly sized LMA can result in incorrect positioning and incorrect ventilation
- Conditions
- Airway Complication of Anesthesia
- Being tested
- respiratory safety
- Keywords
- anesthesia, laryngeal mask, safe respiratory tract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory safetyOther
Which of the 3 lma selection methods is effective in ensuring respiratory safety?
| Study group | Role | What they receive |
|---|---|---|
| body weight | (grup VA; igel=n:40 clasic lma n=40), Receives: Other: respiratory safety | |
| thyromental distance | grup T; igel=n:40 clasic lma n=40) Receives: Other: respiratory safety | |
| resize with 3 fingers | grup p; igel=n:40 clasic lma n=40 Receives: Other: respiratory safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Selection of the appropriate supraglottic airway device for the patient
selecting the most appropriate laryngeal mask to ensure a safe airway. laryngeal mask; It can be selected according to body weight, thyromental distance and three finger size of the hand.Among these mask selection methods, the mask with the best effectiveness and the least complication will be selected
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start22 Jun 2022 (estimated)
- Primary completion7 Aug 2022 (estimated)
- Study completion22 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunus Emre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunus Emre, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430425
- Sponsor's protocol ID
- ytuncdemir-lma
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Classical and I-GEL LMAs Selected by Different Methods in Providing a Safe Airway
- ClinicalTrials.gov ID
- NCT05430425
- Acronym / sponsor ID
- ytuncdemir-lma
- Conditions
- Airway Complication of Anesthesia
- Keywords
- anesthesia, laryngeal mask, safe respiratory tract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Yunus EmreUniversity, hospital or other
- Study start
- 22 Jun 2022 (estimated)
- Primary completion
- 7 Aug 2022 (estimated)
- Study completion
- 22 Oct 2022 (estimated)
- First posted
- 24 Jun 2022 (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.
In recent years, the use of laryngeal masks has been increasing in operating room and non-operating room anesthesia applications. Patients with inappropriate LMA may develop high leakages, gastric distension and inadequate ventilation during ventilation. If the laryngeal masks used to provide a safe airway in the patient are not selected in the appropriate size, adequate ventilation may not be provided, which may lead to various complications such as increased morbidity and mortality. In order to prevent and predict the bad results that may occur, we foresee which method can be chosen more appropriately for the patients and will guide the clinicians.
Detailed description
The laryngeal mask (LMA) is a subragglottic airway device commonly used to provide lung ventilation during general anesthesia. In this study, we aimed to compare the efficacy of classical and I-GEL LMA selected with different techniques.
Successful placement of the Laryngeal Mask Airway (LMA) largely depends on the correct size selection.
The size of the laryngeal mask airway is usually determined by the weight of the patient. However, in some cases an alternative method can be used. The weight of the patient is sometimes unknown (eg, obese, malnourished, sedentary or unconscious patients) and can be unpredictable, especially in children. Therefore, it will be useful to have alternative ways (according to 1. body weight, 2. thyromental distance, 3. dimensioning with three fingers) in determining the appropriate size of the laryngeal mask size. These different methods should be simple to perform and easy to remember.
LMA is increasingly used in elective surgery, resuscitation, difficult airway and emergency situations. Successful use of the LMA largely depends on the correct size selection, method of insertion, and cuff sealing. Placing an improperly sized LMA can result in incorrect positioning and incorrect ventilation
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| body weight | – | Other: respiratory safety(grup VA; igel=n:40 clasic lma n=40), |
| thyromental distance | – | Other: respiratory safetygrup T; igel=n:40 clasic lma n=40) |
| resize with 3 fingers | – | Other: respiratory safetygrup p; igel=n:40 clasic lma n=40 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases aged between 18-65 years, whose elective consents have been obtained, and who will be placed under ASA I-II and LMA under general anesthesia will be included.
Key inclusion criteria (4 listed)
- Elective cases between the ages of 18-65,
- ASA I-II,
- who will be fitted with an LMA by the anesthesia clinic,
- and whose consent has been obtained
Key exclusion criteria (10 listed)
- ->65 years old,
- excessive cachectic or body mass index (BMI) >30 kg/m2,
- those with high risk of regurgitation or aspiration (large hiatal hernia, Zenker's diverticulum, scleroderma, pregnancy, history of gastroesophageal reflux disease, uncontrolled diabetes mellitus and obesity),
- potentially difficult airway (history of airway difficulty, mouth opening <2 cm,
- Mallampati class 4,
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 |
|---|---|---|
| respiratory safetyWhich of the 3 lma selection methods is effective in ensuring respiratory safety? | Other | body weight, resize with 3 fingers, thyromental distance |
Primary outcome
Selection of the appropriate supraglottic airway device for the patient
Time frame: three month
selecting the most appropriate laryngeal mask to ensure a safe airway. laryngeal mask; It can be selected according to body weight, thyromental distance and three finger size of the hand.Among these mask selection methods, the mask with the best effectiveness and the least complication will be selected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Airway Complication of Anesthesia
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
Not yet recruiting
Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
Postoperative Pulmonary Complications
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia, run by Yunus Emre.
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 4 inclusion and 10 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Selection of the appropriate supraglottic airway device for the patient (time frame: three 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 Jun 2022.