Two BedsideNCT06510387
Two Bedside Ultrasound Techniques and Standard Methods for Confirmation of Endotracheal Tube Insertion in Intensive Care Patients
An observational study of Two Bedside and Ultrasound, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Two Bedside, Ultrasound, Endotracheal Tube
- What is being tested?
- Ultrasound using suprasternal method and Ultrasound using subxiphoid method
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- An abnormal airway anatomy.
- Tracheal or endobronchial lesion.
- Significant cervical trauma.
- Cervical abnormality.
- Neck swelling.
- Patients who need cardiopulmonary resuscitation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Eman E Abuharga, MBBCH, 00201207235924, eman171629_pg@med.tanta.edu.eg
Nagat S Elshmaa, MD
About this study
Official 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
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.
Read the 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.
- Conditions
- Two Bedside, Ultrasound, Endotracheal Tube, Intensive Care Patients
- Being tested
- Ultrasound using suprasternal method, Ultrasound using subxiphoid method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound using suprasternal methodDevice
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 methodDevice
Immediately after suprasternal sonography, the research resident will perform subxiphoid sonography to detect diaphragmatic motion, and information will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Correct placement group | The research resident will perform ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of the endotracheal tube. Receives: Device: Ultrasound using suprasternal method; Device: Ultrasound using subxiphoid method | |
| Incorrect placement group | The research resident will perform ultrasonography using suprasternal and subxiphoid methods. Receives: Device: Ultrasound using suprasternal method; Device: Ultrasound using subxiphoid method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes after placement of endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Oct 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Two BedsideStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Elsayed Ismaeil Abuharga, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510387
- Sponsor's protocol ID
- 36264MS323/9/23
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06510387
- Acronym / sponsor ID
- 36264MS323/9/23
- Conditions
- Two Bedside, Ultrasound, Endotracheal Tube, Intensive Care Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Correct placement group | – | Device: Ultrasound using suprasternal method, Device: Ultrasound using subxiphoid methodThe research resident will perform ultrasonography using suprasternal and subxiphoid methods to confirm the correct placement of the endotracheal tube. |
| Incorrect placement group | – | Device: Ultrasound using suprasternal method, Device: Ultrasound using subxiphoid methodThe research resident will perform ultrasonography using suprasternal and subxiphoid methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- An abnormal airway anatomy.
- Tracheal or endobronchial lesion.
- Significant cervical trauma.
- Cervical abnormality.
- Neck swelling.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound using suprasternal methodThe 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 | Correct placement group, Incorrect placement group |
| Ultrasound using subxiphoid methodImmediately after suprasternal sonography, the research resident will perform subxiphoid sonography to detect diaphragmatic motion, and information will be recorded. | Device | Correct placement group, Incorrect placement group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Two Bedside and Ultrasound, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman E Abuharga, MBBCH (00201207235924, eman171629_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy to predict correct placement (time frame: 5 minutes after placement of endotracheal tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.