- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07776847
The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults
21. august 2026 opdateret af: Gizem Demir Şenoğlu, Duzce University
The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults: A Prospective Observational Study
This prospective observational study aims to compare ultrasonographic upper-airway measurements and age-related anatomical differences between young adults (18-40 years) and older adults (>65 years), and to evaluate their effects on laryngeal mask airway (LMA) placement success and position accuracy.
Preoperative airway ultrasonography measurements will be assessed, followed by evaluation of LMA placement, ventilation efficacy, insertion attempts, placement time, and complications.
Ultrasonography will also be used to assess LMA position after placement, with confirmation by leak testing and fiberoptic evaluation.
Preoperative and postoperative gastric volume will additionally be assessed.
Studieoversigt
Status
Rekruttering
Detaljeret beskrivelse
Laryngeal mask airway use is common in general anesthesia.
Age-related anatomical and physiological changes of the upper airway may influence LMA placement in older adults.
The study will prospectively evaluate patients undergoing procedures suitable for LMA placement at Düzce University Faculty of Medicine.
Participants will be divided into young adults (18-40 years) and older adults (>65 years).
Demographic, anthropometric, clinical airway assessment and ultrasonographic airway measurements will be recorded.
Following standardized induction, a ProSeal LMA will be placed by an anesthesia research resident with at least three years of experience.
The number of insertion attempts and placement time will be recorded.
LMA position will be assessed by ultrasonography and compared with leak testing and fiberoptic confirmation.
Ventilation parameters, cuff pressure, LMA position changes, gastric volume and postoperative complications will also be recorded.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
188
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Zennur Güven, Assistant Researcher
- Telefonnummer: +90 5459740213
- E-mail: zennurguven@gmail.com
Studiesteder
-
-
Düzce
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Düzce, Düzce, Tyrkiet (Türkiye)
- Rekruttering
- Düzce University
-
Kontakt:
- Gizem demir şenoğlu, Ass. Prof
- Telefonnummer: 05059313588
- E-mail: gizem123demir@hotmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult patients scheduled for elective surgery under general anesthesia with planned laryngeal mask airway use will be enrolled.
The study population will include two age-based groups: young adults aged 18-40 years with ASA physical status I-II, and older adults aged 65 years or above with ASA physical status I-III.
Eligible participants will be patients with intact neck anatomy and clinical suitability for supraglottic airway management.
Patients with BMI >35 kg/m², pregnancy, known obstructive sleep apnea, significant neck deformity or prior diagnostic/therapeutic neck procedures, or mouth opening <2.5 cm will be excluded.
Beskrivelse
Inclusion Criteria:
- Patient or legally appropriate representative/relative accepts participation as applicable.
- Surgery suitable for LMA placement.
- Age 18-40 years or >65 years.
Exclusion Criteria:
- Pregnancy
- Age <18 years
- History of upper airway surgery
- Gastroesophageal reflux disease, ulcer, or gastrointestinal bleeding history
- Inadequate fasting duration
- Emergency surgery
- Requirement for nasogastric tube placement
- Unstable teeth
- Mouth opening <3 cm
- Recent pulmonary infection
- Recent upper airway infection
- Pulmonary disease associated with increased airway pressures (cystic fibrosis, COPD, interstitial lung disease)
- Restricted cervical movement / inability to achieve required extension
- Ultrasound gel allergy
- Refusal to participate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
young patient
Young adult patients aged 18-40
|
|
older patient
Adult patients over the age of 65
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
First-attempt successful LMA placement rate
Tidsramme: During LMA insertion
|
The primary outcome will compare the proportion of successful first-attempt ProSeal LMA placements between young and older adult groups.
|
During LMA insertion
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2025
Primær færdiggørelse (Anslået)
30. juli 2027
Studieafslutning (Anslået)
30. august 2027
Datoer for studieregistrering
Først indsendt
17. august 2026
Først indsendt, der opfyldte QC-kriterier
17. august 2026
Først opslået (Faktiske)
20. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2025/157
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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