Airway Complication of AnesthesiaNCT05673707
The Effect of Thyromental Height and Other Difficult Airway Evaluation Parameters
An observational study of Airway Complication of Anesthesia, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Many changes occur in the body with age. There are difficulties in endotracheal intubation and the placement of supraglottic airway devices (LMA) in elderly patients due to changes in the tooth and facial structure, and a decrease in temporomandibular joint and neck movements. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- Thyromental Height
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 30 Jan 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: all patients between 65-90 years old who had urological procedure
Who may be able to join
- over 65 years old
- elective operation
- using laryngeal mask device
Who cannot join
- younger than 65 years old
- urgent or emergency operation
- morbidity obese
- contraindications of all laryngeal mask devices using
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
Ankara, 06450
savaş altınsoy, +903125962523, savasaltinsoy@gmail.com
About this study
Official title: The Effect of Thyromental Height and Other Difficult Airway Evaluation Parameters on Laryngeal Mask Placement Success Rate in Elderly Patients
Many changes occur in the body with age. There are difficulties in endotracheal intubation and the placement of supraglottic airway devices (LMA) in elderly patients due to changes in the tooth and facial structure, and a decrease in temporomandibular joint and neck movements. In the literature, there are studies on the relationship between thyromental height measurement and endotracheal intubation difficulty, but there is no study on the relationship between thyromental height measurement and laryngeal mask placement difficulty.
Read the detailed description
Age, gender, height, body weight, body mass index, type of operation, and Mallampati score are recorded in the preoperative evaluations of all patients. For anthropometric measurements, thyromental height, thyromental distance, sterno-mental distance, neck circumference, and mouth opening are measured. After the laryngeal mask is placed after the induction of anesthesia, the location of the LMA is checked with the FOB (fiberoptic bronchoscopy). Ease of insertion was subjectively assessed using a grading score of 1-4 (1, no resistance; 2, mild resistance; 3, moderate resistance; 4, inability to insert the device) by the attending anesthesiologist who inserted the device. After successful placement of the device, the adjustable pressure limiting (APL) valve is adjusted to 30 cm H2O at 3L/minute fresh gas flow, and the airway pressure and leakage amount are measured.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- Thyromental Height
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyromental HeightDiagnostic test
its measure between thyroid and mentum
What is being measured
The primary outcome is the main question the study is designed to answer.
laryngeal mask placement success
The correlation between preoperative thyromental height measurement and laryngeal mask placement success
Measured: during insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jul 2022
- Primary completion30 Jul 2022
- Study completion30 Jan 2023 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673707
- Sponsor's protocol ID
- LMA
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thyromental Height and Other Difficult Airway Evaluation Parameters on Laryngeal Mask Placement Success Rate in Elderly Patients
- ClinicalTrials.gov ID
- NCT05673707
- Acronym / sponsor ID
- LMA
- Conditions
- Airway Complication of Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 6 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.
Many changes occur in the body with age. There are difficulties in endotracheal intubation and the placement of supraglottic airway devices (LMA) in elderly patients due to changes in the tooth and facial structure, and a decrease in temporomandibular joint and neck movements. In the literature, there are studies on the relationship between thyromental height measurement and endotracheal intubation difficulty, but there is no study on the relationship between thyromental height measurement and laryngeal mask placement difficulty.
Detailed description
Age, gender, height, body weight, body mass index, type of operation, and Mallampati score are recorded in the preoperative evaluations of all patients. For anthropometric measurements, thyromental height, thyromental distance, sterno-mental distance, neck circumference, and mouth opening are measured. After the laryngeal mask is placed after the induction of anesthesia, the location of the LMA is checked with the FOB (fiberoptic bronchoscopy). Ease of insertion was subjectively assessed using a grading score of 1-4 (1, no resistance; 2, mild resistance; 3, moderate resistance; 4, inability to insert the device) by the attending anesthesiologist who inserted the device. After successful placement of the device, the adjustable pressure limiting (APL) valve is adjusted to 30 cm H2O at 3L/minute fresh gas flow, and the airway pressure and leakage amount are measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- all patients between 65-90 years old who had urological procedure
Key inclusion criteria (3 listed)
- over 65 years old
- elective operation
- using laryngeal mask device
Key exclusion criteria (4 listed)
- younger than 65 years old
- urgent or emergency operation
- morbidity obese
- contraindications of all laryngeal mask devices using
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 |
|---|---|---|
| Thyromental Heightits measure between thyroid and mentum | Diagnostic test | – |
Primary outcome
laryngeal mask placement success
Time frame: during insertion
The correlation between preoperative thyromental height measurement and laryngeal mask placement success
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
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.
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 Airway Complication of Anesthesia, run by Diskapi Yildirim Beyazit 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 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 6 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact savaş altınsoy (+903125962523, savasaltinsoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
laryngeal mask placement success (time frame: during insertion). 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 6 Jan 2023.