POCUS ASSESSMENT FOR TRACHEAL VS OESOPHAGEAL INTUBATION (PATO)

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication
• Intervention / Treatment: Diagnostic test: Ultrasound Oesophageal Intubation

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28027
    • Recruiting
    • Clinica Universidad de Navarra
    • Contact: Miguel Angel Fernandez-Vaquero, MD,PhD; Phone Number: 7633 0034913531920; Email: mfvaquero@unav.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing scheduled and/or emergency surgery requiring orotracheal intubation.	Diagnostic test: Ultrasound Oesophageal Intubation; Ultrasound Oesophageal intubation detection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Oesophageal Intubation	To assess a diagnostic algorithm for tracheal versus oesophageal intubation using ultrasound and capnography as a confirmatory criterion.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POCUS learning curve	Time required for the application of the ultrasound algorithm and training time for previously untrained personnel.	30 minutes

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Tracheal intubation
• Other Study ID Numbers: PATO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is not neccessary to share any data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No