- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07642206
Combined Ultrasound and Upper Lip Bite Test Assessment of Difficult Laryngoscopy in Obese Patients
Ultrasound-Measured Hyomental Distance Ratio Combined With the Upper Lip Bite Test as a Predictor of Difficult Laryngoscopy in Obese Patients: A Prospective Observational Study
The aim of this observational study is to evaluate the accuracy of the HMDR combined with the ULBT as a predictor of difficult laryngoscopy in obese patients undergoing elective surgery under general anesthesia, regarding:
- Correlation of HMDR-ULBT values with Cormack-Lehane grades during laryngoscopy.
- Comparison of HMDR-ULBT with standard HMDR in predicting difficult laryngoscopy.
Přehled studie
Postavení
Podmínky
Detailní popis
Airway management is a cornerstone of safe anesthesia practice. Difficult laryngoscopy and intubation remain a critical challenge for anesthesiologists. The ability to predict difficult airway situations preoperatively remains crucial, particularly in high-risk populations such as obese patients. These patients have significantly higher rates of difficult mask ventilation and tracheal intubation.
Numerous bedside screening tests have been established to predict difficult laryngoscopy, including the Mallampati classification, thyromental distance, the upper lip bite test (ULBT), and hyomental distance (HMD) measurements. However, none of these tests alone possesses sufficient sensitivity or specificity, and their predictive performance in obese individuals remains variable .
The Hyomental Distance Ratio (HMDR), defined as the ratio of the hyomental distance in maximal head extension to that in the neutral position , is a dynamic parameter reflecting upper airway compliance and anatomical displacement. An HMDR value <1.2 has been associated with increased risk of difficult laryngoscopy in several studies . Traditionally, the HMDR is measured either manually with a ruler or more objectively using ultrasound.
The Upper Lip Bite Test (ULBT) is a simple, validated bedside test assessing mandibular protrusion and temporomandibular joint mobility, two key factors influencing the success of glottic visualization . The ULBT is performed in a conscious state, making it a practical tool in airway assessment.
Given that the ULBT involves active mandibular protrusion, it may mimic the anterior displacement of airway structures achieved during head extension or jaw thrust. Therefore, measuring the hyomental distance while the patient performs the ULBT could serve as a novel dynamic modification of the traditional HMDR-potentially offering a more functional and patient-cooperative measure.
Recent studies have validated the HMDR (extension/neutral) as a useful predictor of difficult laryngoscopy by ultrasound, due to its capacity to evaluate the anterior neck space and upper airway alignment . However, these studies primarily assess neck extension without incorporating mandibular movement, despite its key role in airway visualization. To date, no published studies have evaluated the hyomental distance combined with the ULBT using ultrasound or compared it with the traditional HMDR, leaving an interesting gap in the literature.
Combining the anatomical advantages of anterior neck space assessment with functional jaw mobility via the HMDR combined with the ULBT may yield a more comprehensive and accurate predictor of difficult airway, especially in obese or anatomically challenging patients. This novel approach may detect subtle impairments in upper airway dynamics not captured by the static HMDR alone. To our knowledge, this application has not yet been explored in existing literature.
This study, therefore, aims to evaluate the accuracy of the HMDR combined with the ULBT as a predictor of difficult laryngoscopy in obese patients undergoing elective surgery under general anesthesia, using difficult laryngoscopy-defined as Cormack-Lehane grade 3 or 4-as the primary outcome .
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Makarious Morris Aboelkheir, MSc
- Telefonní číslo: +201225246321
- E-mail: makariousmorris0@gmail.com
Studijní záloha kontaktů
- Jméno: Yasmin Khaled Ahmed, MD
- Telefonní číslo: +201095015566
- E-mail: dr_ykh@hotmail.com
Studijní místa
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypt
- Kasr Al-Ainy Hospital, Cairo University
-
Kontakt:
- Makarious Morris Aboelkheir, MSc
- Telefonní číslo: +201225246321
- E-mail: makariousmorris0@gmail.com
-
Kontakt:
- Yasmin Khalid Ahmed, MD
- Telefonní číslo: +201095015566
- E-mail: dr_ykh@hotmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adult obese patients aged 18 to 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II- III.
- Body Mass Index (BMI) ≥ 30 kg/m² (classified as obese).
- Scheduled for elective surgical procedures requiring general anesthesia with endotracheal intubation.
- Ability to understand and provide informed written consent.
- Cooperative and able to perform the ULBT on command.
- Normal dentition (presence of upper and lower incisors to perform ULBT accurately).
Exclusion Criteria:
- History of maxillofacial trauma, surgery, or congenital facial anomalies affecting mandibular movement or neck anatomy.
- Known or suspected difficult airway requiring awake intubation.
- Patients with limited neck mobility (e.g., cervical spine disease or immobilization).
- Temporomandibular joint disorders or restricted mandibular mobility.
- Pregnancy.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: HMD measured by US in neutral head position , maximum head extension and during upper lip bite test
Hyomental distance will be measured using ultrasound in three positions: neutral head position, maximum head extension, and during the upper lip bite test (ULBT).
|
Hyomental distance will be measured using ultrasound in three positions: neutral head position, maximum head extension, and during the upper lip bite test (ULBT).
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Prediction of difficult laryngoscopic view, defined as Cormack-Lehane Grade 3 or 4 on the first laryngoscopy attempt without external laryngeal manipulation.
Časové okno: Day of surgery from preoperative assessment to first laryngoscopy attempt after induction of general anethesia and after three minutes of mask ventilation.
|
Difficult laryngoscopic view is defined as Cormack-Lehane Grade III or IV during the first laryngoscopy attempt without external laryngeal manipulation Cormack-Lehane classification for laryngoscopic view : grade 1: most of the vocal cords is seen; grade 2: only the posterior part of the vocal cords or the arytenoid cartilages are seen; grade 3: only epiglottis is seen; grade 4: epiglottis is not seen. |
Day of surgery from preoperative assessment to first laryngoscopy attempt after induction of general anethesia and after three minutes of mask ventilation.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Determination of an optimal cutoff value for HMDR-ULBT to predict difficult laryngoscopy.
Časové okno: From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia on the day of surgery
|
Receiver operating characteristic (ROC) curve analysis will be performed to determine the optimal cutoff value of the hyomental distance ratio measured during the upper lip bite test (HMDR-ULBT) for predicting difficult laryngoscopic view, defined as Cormack-Lehane Grade III or IV on the first laryngoscopy attempt without external laryngeal manipulation.
The area under the ROC curve (AUC), sensitivity, specificity, positive predictive value, and negative predictive value corresponding to the optimal cutoff value will be calculated.
|
From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia on the day of surgery
|
|
Comparison of HMDR-ULBT with standard HMDR in predicting difficult laryngoscopy.
Časové okno: From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia.
|
The predictive performance of the hyomental distance ratio measured during the upper lip bite test (HMDR-ULBT) will be compared with that of the standard hyomental distance ratio (HMDR) for predicting difficult laryngoscopic view, defined as Cormack-Lehane Grade III or IV during the first laryngoscopy attempt without external laryngeal manipulation.
Diagnostic accuracy parameters, including sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve, will be compared between the two methods.
|
From preoperative airway assessment until completion of the first laryngoscopy attempt during induction of anesthesia.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Bhanushali A, Date A. Evaluation of upper lip bite test and thyromental height test for prediction of difficult laryngoscopy: A prospective observational study. Airway. 2021;4(3):621-42.
- Hrithma D, K R, Mahadevaiah DT, K N V. A Cross-Sectional Study on Hyomental Distance Ratio (HMDR) as a New Predictor of Difficult Laryngoscopy in ICU Patients. Cureus. 2022 May 28;14(5):e25435. doi: 10.7759/cureus.25435. eCollection 2022 May.
- Liaskou C, Vouzounerakis E, Trikoupi A, Staikou C. [Evaluation of bedside tests and proposal of a model for predicting difficult laryngoscopy: an observational prospective study]. Braz J Anesthesiol. 2020 Mar-Apr;70(2):125-133. doi: 10.1016/j.bjan.2020.02.007. Epub 2020 May 13.
- Liu Y, He Y, Wang X, Li J, Zhang Z, Zhuang X, et al. Advances in airway management in recent 10 years from 2013 to 2023. Anesthesiol Perioper Sci. 2023;1(4):27-30.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Airway Ultrasound
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Hodnocení dýchacích cest
-
Mead Johnson NutritionChulalongkorn University; Ministry of Health, ThailandZatím nenabírámeOutcome Assessment
-
National Taiwan University HospitalNábor
-
Derince Training and Research HospitalDokončenoSpokojenost pacienta | Outcome Assessment
-
University of ZurichDokončenoOutcome Assessment, Health CareŠvýcarsko
-
University of Texas Southwestern Medical CenterDokončenoInterrater Reliability mezi pupillary Assessment
-
Chang Gung Memorial HospitalNeznámýHemodynamické monitorování | Peroperační péče | Outcome Assessment
-
RANDAktivní, ne náborOutcome Assessment | Zdravotní služby pro matkyNigérie
-
National Cancer Institute (NCI)DokončenoNovotvar | Rozdíly ve zdravotnictví | Dostupnost zdravotnických služeb | Outcome AssessmentSpojené státy
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)DokončenoKvalita života | Paliativní péče | Outcome Assessment | Dětský novotvarSpojené státy
-
University of California, Los AngelesDokončenoOutcome Assessment | Anestézie bez opiátů | Opioidní analgezie | Kvalita obnovy (QoR-15)Spojené státy