Lung UltrasoundNCT02556853
Ultrasound for Double Lumen Endotracheal Tube
A study testing Determination of tube position by ultrasound. and Determination of tube position by auscultation. in people with Lung Ultrasound, run by 424 General Military Hospital at 1 site in Greece.
Trial summary
The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®) for the patients of the one group (group U) and by clinical examination for the patients of the other group (group C). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Ultrasound
- What is being tested?
- Determination of tube position by ultrasound. and Determination of tube position by auscultation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2015to Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- Surgery requiring placement of double-lumen endotracheal tube.
- ASA 1-3
Who cannot join
- History of difficult or impossible intubation.
- Clinical findings of possible difficult intubation according to the standard preoperative airway assessment.
- Impossible placement of a double lumen tube
Trial locations and contacts
1 site in 1 country.
Greece1 site
Anesthesia department; 424 Army General Hospital
Thessaloniki, 56429
About this study
Official title: Comparison Between Ultrasound and Clinical Assessment of the Correct Positioning of Left Double Lumen Endotracheal Tube
The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®) for the patients of the one group (group U) and by clinical examination for the patients of the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®). The two methods will be compared in terms of sensitivity and specificity. The main purpose of the study is to determine if the ultrasound can be used for determination of the correct placement of the left sided double lumen endotracheal tube
- Conditions
- Lung Ultrasound
- Being tested
- Determination of tube position by ultrasound., Determination of tube position by auscultation.
- Keywords
- Ultrasound, Double lumen tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of tube position by ultrasound.Device
After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by ultrasound (Sonoscape S6®). The ultrasound probe will be placed between the 2nd and 3rd intercostal space at the level of the midclavicular line parallel to the line. The probe will be slightly moved or tilted until the pleural line is identified. If lung sliding is identified then the ventilation of the lung will be considered adequate. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.
Determination of tube position by auscultation.Other
After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by auscultation of the upper lung fields. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Determination of correct placement of the double lumen tube by lung ultrasound. Receives: Device: Determination of tube position by ultrasound. |
| Clinical | Active comparator | Determination of correct placement of the double lumen tube by clinical examination. Receives: Other: Determination of tube position by auscultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct position of the tube (yes/no).
The anesthesiologist who will place the left-sided double lumen tube will determine if the position of the tube is correct according to the ultrasound or clinical findings.
Measured: Within an average of 5 minutes after the placement of the double lumen tube
Correct position of the tube by bronchoscopy (yes/no).
After the assessment of the tube's position, a second anesthesiologist will verify the position of the tube by bronchoscopy.
Measured: Within an average of 10 minutes after the placement of the double lumen tube.
Secondary outcomes (1)
Time needed
The total time passed from the beginning of laryngoscopy until the final verification of the tube's position.
Measured: Within an average of 10 minutes after the placement of the double lumen tube.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: The Thoracic Surgery Department has almost stopped completely its surgical activities and the completion of the study doesn't seem to be feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung UltrasoundStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Kotsovolis, 424 General Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556853
- Sponsor's protocol ID
- 14074
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Sustic A, Protic A, Cicvaric T, Zupan Z. The addition of a brief ultrasound examination to clinical assessment increases the ability to confirm placement of double-lumen endotracheal tubes. J Clin Anesth. 2010 Jun;22(4):246-9. doi: 10.1016/j.jclinane.2009.07.010.
PubMed 20522353Sustic A, Miletic D, Protic A, Ivancic A, Cicvaric T. Can ultrasound be useful for predicting the size of a left double-lumen bronchial tube? Tracheal width as measured by ultrasonography versus computed tomography. J Clin Anesth. 2008 Jun;20(4):247-52. doi: 10.1016/j.jclinane.2007.11.002.
PubMed 18617120Alvarez-Diaz N, Amador-Garcia I, Fuentes-Hernandez M, Dorta-Guerra R. Comparison between transthoracic lung ultrasound and a clinical method in confirming the position of double-lumen tube in thoracic anaesthesia. A pilot study. Rev Esp Anestesiol Reanim. 2015 Jun-Jul;62(6):305-12. doi: 10.1016/j.redar.2014.06.005. Epub 2014 Aug 20. English, Spanish.
PubMed 25149114
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound and Clinical Assessment of the Correct Positioning of Left Double Lumen Endotracheal Tube
- ClinicalTrials.gov ID
- NCT02556853
- Acronym / sponsor ID
- 14074
- Conditions
- Lung Ultrasound
- Keywords
- Ultrasound, Double lumen tube
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Thoracic Surgery Department has almost stopped completely its surgical activities and the completion of the study doesn't seem to be feasible.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- 424 General Military HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Sep 2015 (estimated)
- 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.
The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®) for the patients of the one group (group U) and by clinical examination for the patients of the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®). The two methods will be compared in terms of sensitivity and specificity. The main purpose of the study is to determine if the ultrasound can be used for determination of the correct placement of the left sided double lumen endotracheal tube
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Device: Determination of tube position by ultrasound.Determination of correct placement of the double lumen tube by lung ultrasound. |
| Clinical | Active comparator | Other: Determination of tube position by auscultation.Determination of correct placement of the double lumen tube by clinical examination. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgery requiring placement of double-lumen endotracheal tube.
- ASA 1-3
Key exclusion criteria (3 listed)
- History of difficult or impossible intubation.
- Clinical findings of possible difficult intubation according to the standard preoperative airway assessment.
- Impossible placement of a double lumen tube
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 |
|---|---|---|
| Determination of tube position by ultrasound.After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by ultrasound (Sonoscape S6®). The ultrasound probe will be placed between the 2nd and 3rd intercostal space at the level of the midclavicular line parallel to the line. The probe will be slightly moved or tilted until the pleural line is identified. If lung sliding is identified then the ventilation of the lung will be considered adequate. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established. | Device | Ultrasound |
| Determination of tube position by auscultation.After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by auscultation of the upper lung fields. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established. | Other | Clinical |
Primary outcome
Correct position of the tube (yes/no).
Time frame: Within an average of 5 minutes after the placement of the double lumen tube
The anesthesiologist who will place the left-sided double lumen tube will determine if the position of the tube is correct according to the ultrasound or clinical findings.
Correct position of the tube by bronchoscopy (yes/no).
Time frame: Within an average of 10 minutes after the placement of the double lumen tube.
After the assessment of the tube's position, a second anesthesiologist will verify the position of the tube by bronchoscopy.
1 secondary outcome
Time needed
Time frame: Within an average of 10 minutes after the placement of the double lumen tube.
Results and safety
The study was stopped early (reason given: The Thoracic Surgery Department has almost stopped completely its surgical activities and the completion of the study doesn't seem to be feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Background: PubMed 20522353Sustic A, Protic A, Cicvaric T, Zupan Z. The addition of a brief ultrasound examination to clinical assessment increases the ability to confirm placement of double-lumen endotracheal tubes. J Clin Anesth. 2010 Jun;22(4):246-9. doi: 10.1016/j.jclinane.2009.07.010.
- Background: PubMed 18617120Sustic A, Miletic D, Protic A, Ivancic A, Cicvaric T. Can ultrasound be useful for predicting the size of a left double-lumen bronchial tube? Tracheal width as measured by ultrasonography versus computed tomography. J Clin Anesth. 2008 Jun;20(4):247-52. doi: 10.1016/j.jclinane.2007.11.002.
- Background: PubMed 25149114Alvarez-Diaz N, Amador-Garcia I, Fuentes-Hernandez M, Dorta-Guerra R. Comparison between transthoracic lung ultrasound and a clinical method in confirming the position of double-lumen tube in thoracic anaesthesia. A pilot study. Rev Esp Anestesiol Reanim. 2015 Jun-Jul;62(6):305-12. doi: 10.1016/j.redar.2014.06.005. Epub 2014 Aug 20. English, Spanish.
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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?
A study testing Determination of tube position by ultrasound. and Determination of tube position by auscultation. in people with Lung Ultrasound, run by 424 General Military Hospital at 1 site in Greece.
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 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: stopped early, as of the sponsor's last update on 9 Jan 2018. 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 Greece. 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 was stopped early (reason given: The Thoracic Surgery Department has almost stopped completely its surgical activities and the completion of the study doesn't seem to be feasible.). Results are not available in the source record.
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?
Correct position of the tube (yes/no). (time frame: Within an average of 5 minutes after the placement of the double lumen tube). The study lists 2 primary outcomes in all. 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 NCT02556853, which also lists 3 linked publications.
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 9 Jan 2018.