Endotracheal IntubationNCT05747248
Tracheal, Lung, and Diaphragmatic Ultrasonography Applications for Rapid Confirmation of Endotracheal Tube Position
An observational study of Endotracheal Intubation, run by Aswan University at 1 site in Egypt.
Trial summary
Nowadays endotracheal intubation is considered a fundamental management procedure during emergency resuscitation. Unrecognized misplacement of the ETT during endotracheal intubation and ventilation, has a reported incidence of 2.9-16.7% and is a frequent cause of morbidity and mortality in emergency intubations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 31 Oct 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients intubated with a cuff ETT
Who may be able to join
- Age >18 years old with endotracheal intubation
- Having normal airway anatomy
Who cannot join
- Age below 18 years old
- Neck deformities,
- Presence in history of neck radiation,
- Cervical spine immobility/instability
- Unstable vital signs
- Unwilling to participate or denial of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Nowadays endotracheal intubation is considered a fundamental management procedure during emergency resuscitation. Unrecognized misplacement of the ETT during endotracheal intubation and ventilation, has a reported incidence of 2.9-16.7% and is a frequent cause of morbidity and mortality in emergency intubations. The aim of this study is to determine the diagnostic accuracy of the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)
- Conditions
- Endotracheal Intubation
- Being tested
- Ultrasonography
- Keywords
- ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Tracheal, diaphragmatic and lung ultrasonography
What is being measured
The primary outcome is the main question the study is designed to answer.
The verification of endotracheal tube position using the ultrasonography in the respiratory intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)
The confirmation of endotracheal tube position using the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Dec 2021
- Primary completion20 Aug 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Galal Sayed, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747248
- Sponsor's protocol ID
- ETT position confimation by US
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sethi AK, Salhotra R, Chandra M, Mohta M, Bhatt S, Kayina CA. Confirmation of placement of endotracheal tube - A comparative observational pilot study of three ultrasound methods. J Anaesthesiol Clin Pharmacol. 2019 Jul-Sep;35(3):353-358. doi: 10.4103/joacp.JOACP_317_18.
PubMed 31543584
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal, Lung, and Diaphragmatic Ultrasonography Applications for Rapid Confirmation of Endotracheal Tube Position
- ClinicalTrials.gov ID
- NCT05747248
- Acronym / sponsor ID
- ETT position confimation by US
- Conditions
- Endotracheal Intubation
- Keywords
- ETT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 28 Feb 2023 (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.
Nowadays endotracheal intubation is considered a fundamental management procedure during emergency resuscitation. Unrecognized misplacement of the ETT during endotracheal intubation and ventilation, has a reported incidence of 2.9-16.7% and is a frequent cause of morbidity and mortality in emergency intubations. The aim of this study is to determine the diagnostic accuracy of the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients intubated with a cuff ETT
Key inclusion criteria (2 listed)
- Age >18 years old with endotracheal intubation
- Having normal airway anatomy
Key exclusion criteria (6 listed)
- Age below 18 years old
- Neck deformities,
- Presence in history of neck radiation,
- Cervical spine immobility/instability
- Unstable vital signs
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 |
|---|---|---|
| UltrasonographyTracheal, diaphragmatic and lung ultrasonography | Device | – |
Primary outcome
The verification of endotracheal tube position using the ultrasonography in the respiratory intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)
Time frame: one hour
The confirmation of endotracheal tube position using the tracheal, diaphragmatic and sonographic estimation of lung sliding for the rapid verification of endotracheal tube position in the intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 31543584Sethi AK, Salhotra R, Chandra M, Mohta M, Bhatt S, Kayina CA. Confirmation of placement of endotracheal tube - A comparative observational pilot study of three ultrasound methods. J Anaesthesiol Clin Pharmacol. 2019 Jul-Sep;35(3):353-358. doi: 10.4103/joacp.JOACP_317_18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Endotracheal Intubation, run by Aswan 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 2 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: finished, as of the sponsor's last update on 2 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The verification of endotracheal tube position using the ultrasonography in the respiratory intensive care unit (RICU) with reference to Co₂ monitors (capnography) (the gold standard technique) (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05747248, which also lists 1 linked publication.
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 2 Mar 2023.