POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION

NCT05983666 | Recruiting

• 1 other identifier: PATO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical importance of airway management has gained prominence in the last decade in most scientific societies with the aim of improving the standard of care. The WHO has focused guidelines for "Safety in Surgery", which attempt to encompass all methods that predict and recognise airway management risk and should be applied by the surgical team, and has therefore created and implemented a surgical checklist that can be useful in reducing the risk of unidentified difficulties. The same suggestion has been included in the Helsinki Declaration on Patient Safety in Anaesthesiology, signed by most European entities in cooperation with the European Society of Anaesthesiology (ESA), the European Board of Anaesthesiology (EBA-UEMS), and the World Federation of Societies of Anaesthesiology (WFA). Confirmation of correct endotracheal tube (ET) placement is a crucial step in airway management, as unrecognised oesophageal intubation can have catastrophic consequences. Numerous methods are used to verify correct ET placement, including visual confirmation of tube passage through the vocal cords during laryngoscopy, chest wall expansion during ventilation, visualisation of the tracheal rings and carina using a flexible bronchoscope, auscultation, capnometry, capnography and chest radiography. These techniques vary in their degree of precision. Although capnography is considered the gold standard for confirming tracheal intubation, it has some important limitations. In recent years, ultrasonography has been introduced as the fifth pillar of the physical examination of the patient: inspection, palpation, percussion, auscultation and insonation. For airway assessment and management, Point-of-Care UltraSound (PoCUS) has been incorporated into routine clinical practice, answering open diagnostic questions, aiding in differential diagnosis and guiding procedures. Thus, investigators propose a simple, quick and easy-to-learn approach for the interpretation of ultrasound imaging findings during airway management.

Conditions

Intubation Complication

Keywords

Tracheal intubation; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Ultrasound Oesophageal Intubation

  To assess a diagnostic algorithm for tracheal versus oesophageal intubation using ultrasound and capnography as a confirmatory criterion.

  5 minutes

Secondary Outcomes (1)

• POCUS learning curve

  30 minutes

Study Arms (1)

Patients undergoing scheduled and/or emergency surgery requiring orotracheal intubation.

Diagnostic Test: Ultrasound Oesophageal Intubation

Interventions

Ultrasound Oesophageal Intubation DIAGNOSTIC_TEST

Ultrasound Oesophageal intubation detection

Patients undergoing scheduled and/or emergency surgery requiring orotracheal intubation.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (male or female) ASA I-III, aged between 18 and 90 years, undergoing scheduled and/or emergency surgery requiring orotracheal intubation. Informed consent form must be signed authorising inclusion in the study.

You may not qualify if:

• A.- Cervical tumours, goitre or patients who have required cervical radiotherapy.
• B.- Abnormalities leading to alterations of the anatomy such as facial/cervical fractures.
• C.- Those who cannot give their consent.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clinica Universidad de Navarra

Madrid, Madrid, 28027, Spain

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 9, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2026
• Study Completion: August 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)