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NCT06701253
Upper Airway Ultrasound Evaluation
trial testing point of care ultrasound in Airway Management in 500 participants. Currently enrolling.
18 November 2024
Quick facts
| Lead sponsor | University of Ioannina |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 8 November 2021 |
| Primary completion | 18 November 2024 |
| Estimated completion | 9 June 2025 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- point of care ultrasound
Conditions studied
- Airway Management — all drugs for Airway Management →
- Point of Care — all drugs for Point of Care →
- Ultrasound — all drugs for Ultrasound →
Sponsor
University of Ioannina
Who can join
Adults 18 to 99, any sex, with Airway Management or Point of Care. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Current guidelines support the use of predictive clinical tests in the evaluation of difficult airway, meaning either difficult bag and mask ventilation, conventional laryngoscopy and/or endotracheal intubation. However, despite the clinical use of these predictive tests, unpredictive difficult laryngoscopy complicates 1.5-13% of cases. Life threatening scenarios may be encountered in patients with difficult or impossible bag and mask ventilation. Anaesthesiologists are familiar with the use of ultrasound, with peripheral nerve blockade and central vascular access representing the most popular applications during the last decades. The ultrasound provides real time and accurate images. According to the current literature, there are only a handful of studies relevant to the application of point of care ultrasound (POCUS), as a new tool in the upper airway evaluation. It is a new field of research with high interest. This is a prospective observational study to investigate if specific ultrasound measurements of the anterior neck can serve as predictors of difficult airway. The ultrasound parameters will be measured preoperatively, during the preanaesthetic evaluation, along with standard clinical prognostic tools, like the mallampati score. The ultrasound parameters to be investigated are: 1. the distance from thyroid isthmus to skin surface, 2. the distance from the hyoid bone to the skin surface, 3. the distance from the anterior commissure of vocal cords to the skin surface, 4. the distance from skin to the trachea at the level of jugular notch, 5. the distance from skin to epiglottis corresponding to half of the distance between thyroid cartilage and hyoid bone, 6. and the angle between glottis and epiglottis. After the induction in anaesthesia, the Cormack Lehane score (grading of the laryngoscopy view) and the Han scale (grading of the degree of difficulty of bag and mask ventilation) will also be recorded. The goal of this study is the investigation of the role of POCUS in the evaluation of difficult bag and mask ventilation and difficult intubation. The primary endpoint is the incidence of difficult bag and mask ventilation and the incidence of difficult laryngoscopy and intubation. Secondary endpoints are the correlations between clinical prognostic tools of difficult airway and the POCUS parameters under investigation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06701253
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Related trials
Other trials of point of care ultrasound
Trials testing the same drug.
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Other recruiting trials for Airway Management
Currently open trials in the same condition.
- NCT07222007 — Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients · recruiting
- NCT07351227 — Pediatric Airway: Noninferiority Trial of Devices for Intubation Assessment · NA · recruiting
- NCT06955884 — Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation · recruiting
- NCT06954857 — The Influence of Standardized Process Management of Laryngeal Mask Airway Placement Based on Pressure Monitoring on the · NA · recruiting
- NCT06990490 — Application of Lateral Position Digestive Endoscopy-Guided Endotracheal Intubation in Anesthesia for Endoscopic Diagnosi · active not recruiting
Other University of Ioannina trials
Trials by the same sponsor.
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- NCT06758518 — Study of the Carpal Tunnel Syndrome in Relation to Stress and Depression Among Medical Students · enrolling by invitation
- NCT07164300 — Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06701253 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Ioannina
- Last refreshed: 22 November 2024
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