ThoracicEcho-ThoraxNCT03836183
Pleuropulmonary Ultrasound With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation
A study testing Pleuropulmonary ultrasound with clinical examination in people with Thoracic and Surgery, run by Association Pro-arte at 1 site in France.
Trial summary
Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which is an invasive procedure. Although rare, several complications are known with, among other things, the occurrence of pulmonary infections, pneumothorax associated with increased pressure in the airways, atelectasis or… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Pleuropulmonary ultrasound with clinical examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2018to 29 Feb 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient will benefit from thoracic or cardiac surgery requiring selective left intubation.
- Affiliation to the French social security
Who cannot join
- Minor patients
- Refusal of the patient
- Patients under guardianship, curators.
- Surgery not compatible with a visualization of the pleural slip in echography: surgery of pneumothorax or liquid effusion
- History likely to disturb the detection of pleural slip on ultrasound: pneumothorax surgery
- Predictable intubation difficulties and the need for selective bronchial blocker intubation
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Pleuropulmonary Ultrasound Associate With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation in Patients Undergoing Thoracic Surgery
Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which is an invasive procedure. Although rare, several complications are known with, among other things, the occurrence of pulmonary infections, pneumothorax associated with increased pressure in the airways, atelectasis or bronchospasm.
Avoid the systematic control by fibroscopy in simple cases which makes it possible to overcome the complications related to its use and its cost.
The investigators want to evaluate the diagnostic value of the echographic strategy in 2 steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left upper lobe) associated with the clinical examination in preoperative by comparing with the gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a positive predictive value of at least 85%.
Read the detailed description
In thoracic surgery, it is common to use selective intubation probes to exclude from ventilation the lung operated by the surgeon. It is recommended to perform a bronchoscopy which is the reference examination to confirm the good position of these probes. The interest of systematically controlling the good position of the left selective intubation probe by fibroscopy is controversial.
The interest of ultrasound for the diagnosis of pleuro-pulmonary pathologies is certain in resuscitation and emergency context for the diagnosis of pneumothorax, haemothorax and atelectasis.
The use of pleuropulmonary ultrasound in anesthesiology is the subject of studies. Several teams used it to ensure proper endotracheal tube positioning and to diagnose selective intubation. In fact, it has been shown that to control the position of the probe more precisely, ultrasound is more efficient than auscultation.
The aim of this work is to show by a large-scale prospective study that pleuropulmonary ultrasound associated with the clinical examination confirms the exclusion of the operated lung. the absence of systematic control of the positioning of the probe by fibroscopy allow financial gain and a reduction in the risk of morbidity related to the realization of this invasive gesture.
- Being tested
- Pleuropulmonary ultrasound with clinical examination
- Keywords
- bronchoscopy, ultrasound, thorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleuropulmonary ultrasound with clinical examinationDiagnostic test
Pleuropulmonary ultrasound associate with a clinical examination
| Study group | Role | What they receive |
|---|---|---|
| ultrasound | Other | * ultrasound is the only study group for all the patients
* pleuropulmonary ultrasound
* clinical examination
* fibroscopy. Receives: Diagnostic Test: Pleuropulmonary ultrasound with clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery.
The presence of all these following data makes it possible to qualify the exclusion as correct. Clinical data collected : absence of vesicular murmur at the auscultation, absence of leaks (less than 10% or insufflation pressures < 4kPa (kilopascal) for a volume of 4 -5ml / kg in spirometry, and absence of bubbles in the bubble test. Ultrasound data collected: absence of pleural slip in 2D mode, presence of the bar code sign in TM mode.
Measured: During peroperative period
Secondary outcomes (4)
to evaluate the diagnostic performance of pleuropulmonary ultrasound alone to diagnose the right exclusion of the operated lung in thoracic surgery.
Only the presence of the two following non metric imaging criteria makes it possible to qualify the exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode.
Measured: During peroperative period
To evaluate the interobserver validity of pleuropulmonary ultrasound as a diagnostic test for pulmonary exclusion.
Number of participant with the presence of the two following non metric imaging criteria makes it possible to qualify the lung exclusion as correct. Ultrasound criteria : absence of pleural sliding in 2D mode, Presence of the bar code sign in TM mode. Evaluation on ultrasonographic loops blinded registered from bronchoscopy diagnosis.
Measured: at the end of the inclusion period, an average of 1 year
Assess the surgeon's satisfaction with lung exclusion: visual analogue scale
Quantified satisfaction scale in visual analogue scale. (from 0: worse outcome, to 10: better outcome)
Measured: at the end of the surgery, day 1
determination of the performance of color Doppler in the diagnosis of pulmonary exclusion, visually assessed by presence of colour.
absence or presence of color in the pulmonary parenchyma on the 3 movements (pulmonary fields on the axillary line of the 2 sides and left upper lobe). The absence of color corresponding to a correct exclusion.
Measured: During ultrasound
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start26 Jul 2018
- Primary completion31 Dec 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pro-arte
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Alabaladejo Pierre, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836183
- Sponsor's protocol ID
- 3-2018-EchoThorax
- Acronym
- Echo-Thorax
- Status last verified
- Jun 2020
- First submitted
- 4 Jan 2019
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Pleuropulmonary Ultrasound Associate With Clinical Examination to Check the Good Position of the Double Lumen Tube Intubation in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03836183
- Acronym / sponsor ID
- Echo-Thorax / 3-2018-EchoThorax
- Keywords
- bronchoscopy, ultrasound, thorax
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Association Pro-arteUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 11 Feb 2019 (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.
Using a new ultrasound approach, allow us to avoid the systematic use of bronchoscopy which is an invasive procedure. Although rare, several complications are known with, among other things, the occurrence of pulmonary infections, pneumothorax associated with increased pressure in the airways, atelectasis or bronchospasm.
Avoid the systematic control by fibroscopy in simple cases which makes it possible to overcome the complications related to its use and its cost.
The investigators want to evaluate the diagnostic value of the echographic strategy in 2 steps (2D and TM) on 3 sections (pulmonary field on the axillary line of the 2 sides and left upper lobe) associated with the clinical examination in preoperative by comparing with the gold standard: fibroscopy. Clinical examination and pleuropulmonary ultrasound should have a positive predictive value of at least 85%.
Detailed description
In thoracic surgery, it is common to use selective intubation probes to exclude from ventilation the lung operated by the surgeon. It is recommended to perform a bronchoscopy which is the reference examination to confirm the good position of these probes. The interest of systematically controlling the good position of the left selective intubation probe by fibroscopy is controversial.
The interest of ultrasound for the diagnosis of pleuro-pulmonary pathologies is certain in resuscitation and emergency context for the diagnosis of pneumothorax, haemothorax and atelectasis.
The use of pleuropulmonary ultrasound in anesthesiology is the subject of studies. Several teams used it to ensure proper endotracheal tube positioning and to diagnose selective intubation. In fact, it has been shown that to control the position of the probe more precisely, ultrasound is more efficient than auscultation.
The aim of this work is to show by a large-scale prospective study that pleuropulmonary ultrasound associated with the clinical examination confirms the exclusion of the operated lung. the absence of systematic control of the positioning of the probe by fibroscopy allow financial gain and a reduction in the risk of morbidity related to the realization of this invasive gesture.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound | Other | Diagnostic Test: Pleuropulmonary ultrasound with clinical examination* ultrasound is the only study group for all the patients * pleuropulmonary ultrasound * clinical examination * fibroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient will benefit from thoracic or cardiac surgery requiring selective left intubation.
- Affiliation to the French social security
Key exclusion criteria (7 listed)
- Minor patients
- Refusal of the patient
- Patients under guardianship, curators.
- Surgery not compatible with a visualization of the pleural slip in echography: surgery of pneumothorax or liquid effusion
- History likely to disturb the detection of pleural slip on ultrasound: pneumothorax surgery
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 |
|---|---|---|
| Pleuropulmonary ultrasound with clinical examinationPleuropulmonary ultrasound associate with a clinical examination | Diagnostic test | ultrasound |
Primary outcome
To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery.
Time frame: During peroperative period
The presence of all these following data makes it possible to qualify the exclusion as correct. Clinical data collected : absence of vesicular murmur at the auscultation, absence of leaks (less than 10% or insufflation pressures < 4kPa (kilopascal) for a volume of 4 -5ml / kg in spirometry, and absence of bubbles in the bubble test. Ultrasound data collected: absence of pleural slip in 2D mode, presence of the bar code sign in TM mode.
4 secondary outcomes
to evaluate the diagnostic performance of pleuropulmonary ultrasound alone to diagnose the right exclusion of the operated lung in thoracic surgery.
Time frame: During peroperative period
To evaluate the interobserver validity of pleuropulmonary ultrasound as a diagnostic test for pulmonary exclusion.
Time frame: at the end of the inclusion period, an average of 1 year
Assess the surgeon's satisfaction with lung exclusion: visual analogue scale
Time frame: at the end of the surgery, day 1
determination of the performance of color Doppler in the diagnosis of pulmonary exclusion, visually assessed by presence of colour.
Time frame: During ultrasound
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 11 Jun 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. This study is not recruiting at the moment.
Alabaladejo Pierre principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleuropulmonary ultrasound with clinical examination in people with Thoracic and Surgery, run by Association Pro-arte at 1 site in France.
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 7 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 11 Jun 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 France. 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?
To evaluate the performance of the clinical examination associated with pleuropulmonary ultrasound in order to diagnose the correct exclusion of the operated lung in thoracic surgery. (time frame: During peroperative period). 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 11 Jun 2020.