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

NCT06510387 | Recruiting

• 1 other identifier: 36264MS323/9/23
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Two Bedside; Ultrasound; Endotracheal Tube; Intensive Care Patients

Outcome Measures

Primary Outcomes (1)

• Accuracy to predict correct placement

  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.

  5 minutes after placement of endotracheal tube

Study Arms (2)

Correct placement group

The research resident will perform ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of the endotracheal tube.

Device: Ultrasound using suprasternal method; Device: Ultrasound using subxiphoid method

Incorrect placement group

The research resident will perform ultrasonography using suprasternal and subxiphoid methods.

Device: Ultrasound using suprasternal method; Device: Ultrasound using subxiphoid method

Interventions

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.

Correct placement group; Incorrect placement group

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.

Correct placement group; Incorrect placement group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \> 18 years old, of both sexes undergoing endotracheal intubation admitted to the emergency and traumatology department ICU between October 2023 to September 2024.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Eman E Abuharga, MBBCH

CONTACT

00201207235924; eman171629_pg@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Emergency Medicine and Traumatology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 19, 2024
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)