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NCT Number: NCT05983666

POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Universidad de Navarra

Madrid, 28027, Spain

Location status: Recruiting

Location contact

Miguel Angel Fernandez-Vaquero, MD,PhD

CONTACT

[email protected]

0034913531920 ext. 7633

About this study

The first step of the algorithm is to locate the oesophagus by asking the patient to swallow. The ultrasound transducer is placed transversely on the anterior surface of the neck at the paratracheal level (usually located on the left side), 1-2 cm above the sternal notch or jugulum. In this image, the trachea is shown as a hyperechoic, curvilinear image (air-mucosa interface), showing a posterior reverberation artefact called a comet tail. During the intubation technique, this ultrasound window allows the physician to observe the real-time passage of the tube into the trachea, confirming correct tracheal intubation only if a single air-mucosa interface with its comet tail is maintained. This can then be verified by capnography (if available) or by lung sliding.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Ultrasound Oesophageal Intubation

Diagnostic Test

Ultrasound Oesophageal intubation detection

Primary outcomes

  1. Ultrasound Oesophageal Intubation

    Time frame: 5 minutes

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

Secondary outcomes

  1. POCUS learning curve

    Time frame: 30 minutes

    Time required for the application of the ultrasound algorithm and training time for previously untrained personnel.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Acronym: PATO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2023
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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