- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07813104
Comparative Analysis of a Preoperative Airway Ultrasound Protocol and Direct Laryngoscopy in Oncologic Surgery Patients
This prospective observational study evaluated the predictive performance of the Difficult Airway Evaluation with Sonography (DARES) protocol for identifying difficult laryngoscopy and other airway management difficulties in adult patients undergoing elective oncologic surgery.
Preoperative airway ultrasonography was performed together with conventional clinical airway assessment. Ultrasound parameters included the distance from skin to epiglottis (DSE), hyomental distance (HMD) measured in different head positions, hyomental distance ratios (HMDR1 and HMDR2), and tongue thickness (TT). Conventional airway assessment parameters were also recorded.
The primary objective was to evaluate the ability of ultrasound-derived airway parameters to predict difficult laryngoscopy, defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4) during direct laryngoscopy, and to compare their predictive performance with conventional clinical airway assessment methods.
Secondary objectives included evaluating the relationship between ultrasound parameters and difficult mask ventilation, assessed using the Han scale; investigating their relationship with difficulties or complications encountered during extubation; and exploring differences in airway ultrasound parameters and their predictive performance across oncologic patient subgroups.
Přehled studie
Postavení
Detailní popis
This prospective observational cohort study evaluated the predictive performance of the previously described Difficult Airway Evaluation with Sonography (DARES) protocol in adult patients undergoing elective oncologic surgery.
The study was conducted at the Department of Anesthesiology and Reanimation, Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital. A total of 118 participants were enrolled. All participants underwent preoperative airway assessment and perioperative airway management according to routine clinical practice.
The DARES protocol incorporates selected sonographic parameters used for difficult airway assessment. Preoperative airway ultrasonography was performed in the premedication unit using a Mindray® ultrasound system. Sonographic measurements included skin-to-epiglottis distance (DSE), hyomental distance (HMD) measured in different head positions, hyomental distance ratios (HMDR1 and HMDR2), and tongue thickness (TT). DSE was measured using a 5-14 MHz linear probe, while HMD and TT were measured using a 4-10 MHz curvilinear probe. Ultrasound examinations were performed by a single trained investigator to minimize interobserver variability.
In addition to the ultrasonographic measurements, conventional clinical airway assessment parameters were recorded. Mallampati classification was assessed preoperatively. Mask ventilation difficulty was evaluated using the Han scale, and laryngoscopic view was assessed using the Cormack-Lehane grading system during direct laryngoscopy. Difficult laryngoscopy was defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4). Difficulties and complications encountered during extubation were also prospectively recorded.
For patient safety, the results of the preoperative ultrasonographic airway assessment were made available to the anesthesiologist responsible for airway management, allowing appropriate precautions to be taken when difficult airway management was anticipated. Therefore, the anesthesiologist performing airway management was not blinded to the ultrasound findings. To reduce measurement-related observer variability, preoperative ultrasound measurements and intraoperative airway assessments were performed and recorded by different individuals.
The primary objective was to evaluate the predictive performance of ultrasound-derived airway parameters for difficult laryngoscopy and to compare their performance with conventional clinical airway assessment. Secondary evaluations included the relationship between sonographic airway parameters and mask ventilation difficulty, difficulties or complications encountered during extubation, and exploratory analyses according to oncologic tumor type.
Collected data included age, sex, body mass index, comorbidities, oncologic history, previous surgery and radiotherapy, Mallampati classification, previous anesthesia history, American Society of Anesthesiologists (ASA) physical status, Cormack-Lehane grade, Han mask ventilation grade, anesthesia type and duration, difficulties encountered during mask ventilation, and difficulties or complications encountered during extubation. Data were recorded using a dedicated case report form together with standard anesthesia records.
Statistical analyses were performed using IBM SPSS Statistics version 25.0. The distribution of continuous variables was assessed using the Shapiro-Wilk or Kolmogorov-Smirnov test, as appropriate, and homogeneity of variances was assessed using Levene's test. Continuous variables were summarized using appropriate descriptive statistics according to their distribution, while categorical variables were presented as frequencies and percentages.
Comparisons between two independent groups were performed using the independent-samples t-test or Mann-Whitney U test, as appropriate. Comparisons involving more than two groups were performed using one-way analysis of variance (ANOVA) or the Kruskal-Wallis test. Categorical variables were compared using the Pearson chi-square test or Fisher's exact test, as appropriate.
The discriminatory performance of sonographic airway parameters, including DSE, HMD, HMDR1, HMDR2, and TT, was evaluated using receiver operating characteristic (ROC) curve analysis. Areas under the ROC curve (AUCs) were calculated, and optimal cutoff values were determined using the Youden Index. Diagnostic performance measures, including sensitivity, specificity, positive predictive value, and negative predictive value, were calculated where appropriate. Associations between continuous variables were evaluated using appropriate correlation analyses. A two-sided p value <0.05 was considered statistically significant.
No study-specific therapeutic intervention was performed, and participation did not require deviation from routine perioperative airway management.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Ankara, Turecko (Türkiye), 06170
- Ankara Dr. Abdurrahman Yurtaslan Onkoloji Eğitim ve Araştırma Hastanesi
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Age ≥18 years Undergoing elective oncologic surgery ASA physical status I-III No history of previous head or neck surgery No history of radiotherapy to the head or neck region
Exclusion Criteria:
Age <18 years Emergency surgery ASA physical status IV Previous head or neck surgery Previous radiotherapy to the head or neck region Missing data in patient study forms
Patients scheduled to undergo head and neck surgery were not excluded if they had no history of previous head or neck surgery or radiotherapy to the head and neck region.
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Association Between Preoperative Airway Ultrasound Measurements and Cormack-Lehane Grade During Direct Laryngoscopy
Časové okno: Preoperative assessment through direct laryngoscopy during induction of general anesthesia
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The association between preoperative airway ultrasound measurements and laryngoscopic difficulty was assessed.
Ultrasound measurements included skin-to-epiglottis distance (DSE, measured in millimeters), hyomental distance (HMD, measured in millimeters) in neutral, ramped, and maximally extended head positions, hyomental distance ratios (HMDR1 and HMDR2, dimensionless ratios), and tongue thickness (TT, measured in millimeters).
Laryngoscopic difficulty was assessed during direct laryngoscopy using the Cormack-Lehane grading system (grades 1, 2a, 2b, 3, and 4).
Difficult laryngoscopy was defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4).
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Preoperative assessment through direct laryngoscopy during induction of general anesthesia
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Association Between Preoperative Airway Ultrasound Parameters and Difficult Mask Ventilation Assessed Using the Han Scale
Časové okno: During induction of general anesthesia
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The association between preoperative airway ultrasound measurements and difficult mask ventilation was evaluated.
Ultrasound parameters included skin-to-epiglottis distance (DSE, measured in millimeters), hyomental distance (HMD, measured in millimeters), hyomental distance ratios (HMDR1 and HMDR2, dimensionless ratios), and tongue thickness (TT, measured in millimeters).
Mask ventilation difficulty was assessed using the Han scale (grades 1-4).
Difficult mask ventilation was defined as Han grade 3 or 4. Ultrasound measurements were compared between participants with and without difficult mask ventilation.
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During induction of general anesthesia
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Association Between Difficult Laryngoscopy and Extubation Difficulties or Complications
Časové okno: Postoperative assessment
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Difficult laryngoscopy was assessed using the Cormack-Lehane grading system during direct laryngoscopy and was defined as a Cormack-Lehane grade >2a (grades 2b, 3, or 4).
Participants were classified as having either difficult or non-difficult laryngoscopy.
Extubation difficulties or complications were prospectively recorded as present or absent during extubation.
The proportion of participants experiencing extubation difficulties or complications was compared between the difficult and non-difficult laryngoscopy groups.
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Postoperative assessment
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Sencer Uçar, MD, Ankara Dr. Abdurrahman Yurtaslan Onkoloji Eğitim ve Araştırma Hastanesi
- Ředitel studie: Tuğba Aşkın, MD, Ankara Dr. Abdurrahman Yurtaslan Onkoloji Eğitim ve Araştırma Hastanesi
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další identifikační čísla studie
- AbdurrahmanYAOTRH-AR-TA-01
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- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
- CSR
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