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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Endotracheal Tube; Ultrasound; Intensive Care Patients; Two Bedside
• Intervention / Treatment: Device: Ultrasound using suprasternal method; Device: Ultrasound using subxiphoid method

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Eman E Abuharga, MBBCH; Phone Number: 00201207235924; Email: eman171629_pg@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Shaimaa F Abdelkader, MD
      • Contact: Eman E Abuharga, MBBCH; Phone Number: 00201207235924; Email: eman171629_pg@med.tanta.edu.eg
      • Sub-Investigator: Nagat S Elshmaa, MD
      • Sub-Investigator: Sherif S El-Abd, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Device: Ultrasound using subxiphoid method; Immediately after suprasternal sonography, the research resident will perform subxiphoid sonography to detect diaphragmatic motion, and information will be recorded.
Incorrect placement group; The research resident will perform ultrasonography using suprasternal and subxiphoid methods.	Device: Ultrasound using suprasternal method; 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.; Device: Ultrasound using subxiphoid method; Immediately after suprasternal sonography, the research resident will perform subxiphoid sonography to detect diaphragmatic motion, and information will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 14, 2024
• First Submitted That Met QC Criteria: July 14, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 14, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 36264MS323/9/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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