Diagnostic AccuracyNCT04740385
Role of Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube Placement in Thoracic Surgeries
An observational study of Diagnostic Accuracy, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
to assess the efficacy of lung ultrasound versus conventional auscultation method and fiberoptic bronchoscopy in confirmation of double lumen tube position Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diagnostic Accuracy
- What is being tested?
- Lung auscultation, Fiberoptic bronchoscopy and Lung Ultrasound
- Type of treatment
- Medical device
- How many people
- 117 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2021to 30 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung cancer patients undergoing thoracic surgeries requiring double lumen intubation
Who may be able to join
- patients scheduled for surgeries under general anesthesia requiring double lumen endotracheal intubation
- ASA I-II
Who cannot join
- patient refusal
- patients not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of anesthesia and pain medicine. National Cancer Institute
Cairo, 11796
About this study
Official title: Role of Transthoracic Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube
to assess the efficacy of lung ultrasound versus conventional auscultation method and fiberoptic bronchoscopy in confirmation of double lumen tube position
Read the detailed description
Confirmation of double lumen tube position by auscultation followed fiberoptic bronchoscopy then lung ultrasound. After double lumen intubation all patient tube position will be confirmed using auscultation then fiberoptic bronchoscopy then lung ultrasound
- Conditions
- Diagnostic Accuracy
- Being tested
- Lung auscultation, Fiberoptic bronchoscopy, Lung Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung auscultationDiagnostic test
auscultation of air entry through chest wal
Fiberoptic bronchoscopyDevice
Checking correct double lumen position through direct vision using fiberoptic bronchoscopy
Lung UltrasoundDevice
real time visualization of air entry to the lungs using trans-thoracic lung ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer patients | Correct position of double lumen endotracheal tube will be assessed using lung sonography, routine chest auscultation and fiberoptic brochoscopy Receives: Diagnostic Test: Lung auscultation; Device: Fiberoptic bronchoscopy; Device: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of lung ultrasound in confirmation of correct double lumen position
real time visulaization of air entry to the lung
Measured: 5 minutes
Secondary outcomes (1)
procedural time
time taken to confirm tube position
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start3 Feb 2021
- Primary completion25 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic AccuracyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Youssef Elsabeeny, National Cancer Institute, Egypt
- Investigators
- Walaa Y Elsabeeny, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740385
- Sponsor's protocol ID
- 202101-2P-02002
- Status last verified
- Jul 2022
- First submitted
- 1 Feb 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transthoracic Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube
- ClinicalTrials.gov ID
- NCT04740385
- Acronym / sponsor ID
- 202101-2P-02002
- Conditions
- Diagnostic Accuracy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 5 Feb 2021 (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.
to assess the efficacy of lung ultrasound versus conventional auscultation method and fiberoptic bronchoscopy in confirmation of double lumen tube position
Detailed description
Confirmation of double lumen tube position by auscultation followed fiberoptic bronchoscopy then lung ultrasound. After double lumen intubation all patient tube position will be confirmed using auscultation then fiberoptic bronchoscopy then lung ultrasound
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer patients | – | Diagnostic Test: Lung auscultation, Device: Fiberoptic bronchoscopy, Device: Lung UltrasoundCorrect position of double lumen endotracheal tube will be assessed using lung sonography, routine chest auscultation and fiberoptic brochoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung cancer patients undergoing thoracic surgeries requiring double lumen intubation
Key inclusion criteria (2 listed)
- patients scheduled for surgeries under general anesthesia requiring double lumen endotracheal intubation
- ASA I-II
Key exclusion criteria (2 listed)
- patient refusal
- patients not meeting the inclusion criteria
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 |
|---|---|---|
| Lung auscultationauscultation of air entry through chest wal | Diagnostic test | Lung cancer patients |
| Fiberoptic bronchoscopyChecking correct double lumen position through direct vision using fiberoptic bronchoscopy | Device | Lung cancer patients |
| Lung Ultrasoundreal time visualization of air entry to the lungs using trans-thoracic lung ultrasound | Device | Lung cancer patients |
Primary outcome
sensitivity and specificity of lung ultrasound in confirmation of correct double lumen position
Time frame: 5 minutes
real time visulaization of air entry to the lung
1 secondary outcome
procedural time
Time frame: 5 minutes
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 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Walaa Y Elsabeeny, MD principal investigator
Lecturer
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 Diagnostic Accuracy, run by National Cancer Institute, Egypt 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 2 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 19 Jul 2022. 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?
sensitivity and specificity of lung ultrasound in confirmation of correct double lumen position (time frame: 5 minutes). 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 2022.