ClinicalTrials.gg
RecruitingNCT05983666PATOUpdated Apr 14, 2026

POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION

An observational study in Intubation Complication, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Intubation Complication

Keywords

  • Tracheal intubation
  • Ultrasound
03

In context

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 160 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

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

    Diagnostic Test: Ultrasound Oesophageal Intubation

Interventions

  • Diagnostic testUltrasound Oesophageal Intubation

    Ultrasound Oesophageal intubation detection

06

What researchers measure

Primary outcomes

  1. Ultrasound Oesophageal Intubation

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

    Time frame: 5 minutes

Secondary outcomes

  1. POCUS learning curve

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

    Time frame: 30 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — It is not neccessary to share any data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05983666
Responsible party
Sponsor
First posted
Aug 9, 2023
Start date
Jul 1, 2023
Primary completion
Jul 1, 2026 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Apr 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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