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NCT Number: NCT06510387

Two Bedside Ultrasound Techniques and Standard Methods for Confirmation of Endotracheal Tube Insertion in Intensive Care Patients

This cross-sectional observational study aims to predict the sensitivity and specificity of ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of endotracheal tubes compared to standard methods in intensive care patients.

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Key information

Conditions

Two Bedside Endotracheal Tube Intensive Care Patients Ultrasound

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Eman E Abuharga, MBBCH

CONTACT

[email protected]

00201207235924

Nagat S Elshmaa, MD

SUB_INVESTIGATOR

Shaimaa F Abdelkader, MD

SUB_INVESTIGATOR

Sherif S El-Abd, MD

SUB_INVESTIGATOR

About this study

Endotracheal intubation is the primary medical procedure used for securing the airway, confirmation of endotracheal tube (ETT) placement is essential to prevent hypoxia and aspiration. The best primary approach to confirm endotracheal tube placement is observation of the tube passage through the vocal cords followed by assessment based on chest and epigastric auscultation.

Ultrasound machines are now increasingly available in emergency departments and intensive care units. It is a non-invasive, portable and serves as a real-time diagnostic tool with rapid and accurate results.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients > 18 years old.
  • Both sex.
  • All patients requiring prophylactic airway management e.g (patient with Glasgow Coma Scale <8) with endotracheal intubation in the intensive care unit.

Exclusion criteria

  • An abnormal airway anatomy.
  • Tracheal or endobronchial lesion.
  • Significant cervical trauma.
  • Cervical abnormality.
  • Neck swelling.
  • Patients who need cardiopulmonary resuscitation.

Treatment and study plan

Ultrasound using suprasternal method

Device

The research resident will perform suprasternal ultrasound (US) with a curvilinear probe) C6-2) of US machine (Philips Affiniti 50) which will be placed transversely on the suprasternal area just above to the suprasternal notch immediately after intubation, The position of the trachea will be determined by a hyperechoic air-mucosa (A-M) interface with reverberation artifact posteriorly (comet-tail artifact).

The position of endotracheal tube (ETT), when it is placed in trachea, will be defined as observable contour between A-M and comet-tail artifact. If the second contour appears, it will be similar to the second airway which is called double-tract sign which means that the ETT will be in the esophagus. (7) If the position of the esophagus is suspected of being exactly behind the trachea, operator of ultrasound can specify the location of the esophagus by moving the probe to the left and right sides during scan.

Ultrasound using subxiphoid method

Device

Immediately after suprasternal sonography, the research resident will perform subxiphoid sonography to detect diaphragmatic motion, and information will be recorded.

Primary outcomes

  1. Accuracy to predict correct placement

    Time frame: 5 minutes after placement of endotracheal tube

    Accuracy in predicting the correct placement of the endotracheal tube will be assessed using Sensitivity and Specificity, positive predictive value (PPV), and negative predictive value (NPV) for each ultrasound technique.

Study contacts

Contact information is provided by the study sponsor or research team.

Eman E Abuharga, MBBCH

CONTACT

[email protected]

00201207235924

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison of Two Bedside Ultrasound Techniques and Standard Methods for Confirmation of Endotracheal Tube Insertion in Intensive Care Patients, A Cross-Sectional Observational Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

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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