Endotracheal Tube Wrongly Placed During Anesthetic ProcedureNCT04216199
Role of Point of Care Ultrasound in Endotracheal Tube Placement
A study testing Point of care Ultrasound in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Role of point of care ultrasound in endotracheal tube placement in children Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- Point of care Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2019to 20 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children below 18 years needing endotracheal intubation.
Who cannot join
- Age more than 18 years.
- Patients with significant neck or lung pathology.
- Patients with elective intubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam, Ass. Prof., 00201009221243, sheriefabdelsalam@yahoo.com
About this study
Official title: Role of Point of Care Ultrasound in Confirmation of Endotracheal Tube Placement in Children
Role of point of care ultrasound in endotracheal tube placement in children
Read the detailed description
Role of point of care ultrasound in confirmation of endotracheal tube placement in children
- Being tested
- Point of care Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care UltrasoundDevice
Also called POC Ultrasound
Point of care Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Point of care Ultrasound | Experimental | Point of care Ultrasound for placement of endotracheal tube Receives: Device: Point of care Ultrasound |
| Traditional | No intervention | Traditional method of insertion of endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with correct placement of endotracheal tube
The number of patients with correct placement of endotracheal tube
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Nov 2019
- Primary completion1 Dec 2030 (estimated)
- Study completion20 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube Wrongly Placed During Anesthetic ProcedureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Fekry khater, Msc, Principal investigator, Emergency medicine department - Alazhar UniversityMohamed S Sharaf, Prof., Principal investigator, Anasthesia and Pain department - Alazhar UniversityMohamed H Elshafey, Prof, Study director, Radiodiagnosis Department - Tanta UniversityMohamed G Elbahnasawy, Lecturer, Study director, Emergency medicine department - Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216199
- Sponsor's protocol ID
- elbahnasawy
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Point of Care Ultrasound in Confirmation of Endotracheal Tube Placement in Children
- ClinicalTrials.gov ID
- NCT04216199
- Acronym / sponsor ID
- elbahnasawy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 20 Dec 2030 (estimated)
- First posted
- 2 Jan 2020 (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.
Role of point of care ultrasound in endotracheal tube placement in children
Detailed description
Role of point of care ultrasound in confirmation of endotracheal tube placement in children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point of care Ultrasound | Experimental | Device: Point of care UltrasoundPoint of care Ultrasound for placement of endotracheal tube |
| Traditional | No intervention | –Traditional method of insertion of endotracheal tube |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children below 18 years needing endotracheal intubation.
Key exclusion criteria (3 listed)
- Age more than 18 years.
- Patients with significant neck or lung pathology.
- Patients with elective intubation
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 |
|---|---|---|
| Point of care UltrasoundAlso: POC UltrasoundPoint of care Ultrasound | Device | Point of care Ultrasound |
Primary outcome
Number of patients with correct placement of endotracheal tube
Time frame: 6 months
The number of patients with correct placement of endotracheal tube
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Fekry khater, Msc principal investigator
Emergency medicine department - Alazhar University
Mohamed S Sharaf, Prof. principal investigator
Anasthesia and Pain department - Alazhar University
Mohamed H Elshafey, Prof study director
Radiodiagnosis Department - Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of care Ultrasound in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Sherief Abd-Elsalam 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Jan 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with correct placement of endotracheal tube (time frame: 6 months). 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 2 Jan 2020.