Thoracic AnesthesiaALFIONCT03912311
Auscultation, Lus, Fob In Olv (ALFIO)
An observational study of Thoracic Anesthesia and Lung Ultrasound, run by University of Parma at 1 site in Italy.
Trial summary
The study will be to demonstrate that, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) in OR is more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Anesthesia, Lung Ultrasound, Left Double-lumen Tube
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 2 Apr 2019to 2 Jun 2020
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent elective thoracic surgery (video-assisted thoracic surgery or open thoracotomy) requiring lung isolation and endotracheally intubation by left double lumen tube
Who may be able to join
- Signed informed consent
- Age > 18 years
- Patients who underwent elective thoracic surgery (video-assisted thoracic surgery or open thoracotomy) requiring lung isolation and endotracheally intubation by LDLT
Who cannot join
- Not signed informed consent
- Age < 18 years
- Previous history of thoracic surgery
- Planned use of right double lumen tube
- Pleural diseases: pleural spill, pneumothorax, mesothelioma, previous pleurodesis
- Neuromuscular disease with proved diaphragmatic disfunction
Show all 10Show fewer
- Thoracic subcutaneous emphysema
- Difficult endotracheally intubation or more than 3 attempts made by an experienced anesthesiologist or alternative device use
- Pregnancy
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Diagnostic Performances of Auscultation and Ultrasonography Respect of Fiberoptic Bronchoscopy in the Valuation of Positioning of Endotracheal Double-lumen Tube in Elective Thoracic Surgery
The study will be to demonstrate that, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) in OR is more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. The aim of the study is to demonstrate how lung ultrasound can be considered an attractive alternative to the routine use of fiberbronchoscope as a first line diagnostic tool to verify the correct position of left double lumen tube.
Read the detailed description
Most procedures in thoracic surgery require exclusion from ventilation of the lung undergoing surgery. One-lung ventilation (OLV), it is obtained mainly through the placement of a bi-lumen tube (DLT) in the patient's airway. A frequent complication that occurs during OLV it's unrecognized bad positioning of the DLT which can lead to serious complications such as hypoventilation, hypoxemia, not optimal collapse of the operated lung and damage to the trachea or main bronchi.
The latest SIAARTI recommendations (2009) advocate in all patients use of fiberbronchoscope (FOB) to control and correct the positioning of the DLT (gold standard) after the orotracheal intubation and after the positioning in lateral decubitus. The usual clinical practice expects to performing lung exclusion tests by auscultation of the 2 hemithorax in succession. But the scientific evidence shows how this practice has a poor sensitivity and specificity in assessing the correct positioning of the left DLT (LDLT). From literature, as from everyday clinical experience, it is known that FBS cannot always be performed Finally, the research wants to shed light how the fiberoptic bronchoscopy (FBS) is an invasive maneuver that is not free from serious complications (mucosal lesions and infections).
Ultrasound (US) over the last 15 years has made an important contribution to the assessment and management of the airways. US quickly and effectively are able to show the excursion of the diaphragm and pleura, qualitative and quantitative indicators of lung expansion. If the endotracheal tube is in the correct position, a bilateral and symmetrical movement of the domes of each hemi-diaphragm (B-Mode and M-mode) can be appreciated, while in the intercostal window, the so-called "lung-sliding" will be visible. In the absence of ventilation, the diaphragmatic excursion and the "lung-sliding" will not be detectable in the explored hemi-thorax.
Although FBS remains the gold standard for controlling the correct position of LDLT under thoracic anesthesia, and is often crucial as a guide to its repositioning, from the researchers point of view, the use of FOB may not be routinely necessary in all patients, but its use could be reserved for selected cases in which the positioning itself is difficult or in case of intraoperative displacement. Primary objective is to demonstrate how, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) to the operating room is a more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. LUS is a non-invasive, safe and free from side effects technique that can be performed at the patient's bed. The study aims to demonstrate how LUS can be considered an attractive alternative to the routine use of FOB as a first line diagnostic tool to verify the correct position of LDLT.
For each surgical procedure 3 researchers will participate, each with a specific independent role: the auscultation researcher (AR), which will have the task of performing the oral-tracheal intubation and auscultation with phonendoscope pre-and post-induction of general anesthesia and after positioning the patient in lateral decubitus; the ultrasound researcher (UR), i.e. the anesthesiologist who will perform the pre- and post-induction of the AG ultrasound evaluation and after positioning the patient in lateral decubitus; the Fiberscope Researcher (FR), whom will perform the fibrobroncoscopic verification of the LDLT at the end of the clinical and ultrasound assessment and after the positioning in lateral position. He will reposition the endotracheal tube in case of mal positioning or intra-operative displacement of the same.
Upon the arrival of the patients in the operating room, and after applying the standard operative monitoring for the planned surgery, the AR will perform a preliminary thoracic auscultation, in order to verify the presence of normal lung sounds in spontaneous breathing. The UR will perform a preliminary thoracic ultrasound scanning, in order to verify the presence of long sliding (LS) and diaphragmatic displacement (DD). Then, after the positioning of adequate venous accesses and eventually a medium-thoracic peridural catheter, AR will proceed to induce general anesthesia. Patients will undergo video-thoracoscopy or thoracotomy operations that require mono-pulmonary ventilation (OLV) for each part or for the entire duration of the operation. The choice of the appropriate LDLT size will be made on the basis of Brodsky's anthropometric criteria. After sedation and curarization, direct laryngoscopy will be performed with a Macintosh blade and patients will be intubated with a left bi-lumen (LDLT) Carlens or Robertshaw tube by the AR, after that he will also perform auscultation. After inflating the tracheal cuff and verifying the symmetricity of the vesicular murmure on both pulmonary fields in two pre-established points per side (apex = II-III intercostal space on the hemiclavicular; base = V intercostal space on the middle axilla), the bronchial cuff will be inflated and the auscultation repeated by first clamping the tracheal lumen and then the bronchial lumen. If the LDLT is correctly positioned the MV will be present at the apex and base of the ventilated lung and absent in the contralateral points of the excluded lung. Otherwise the LDLT will be considered wrongly positioned and the AR will have 3 attempts to reposition the device. The AR will record the results of the verification carried out on the CRF and will leave its role in the OR at the UR. The latter, using a 6-13 MHz linear ultrasound probe, will evaluate, in B-mode and M-mode, the presence / absence of the LS and the LP at the level of the II-III intercostal space on the hemiclavicular, while with a convex ultrasound probe 3,5-5 MHz placed orthogonally to the costal arch on the anterior axillary line, the diaphragmatic displacement will be searched and measured. The bi-lumen tube will be considered correctly positioned in the presence of LS and DD in the ventilated lung and in their absence in the excluded lung. Otherwise the LDLT will be considered wrongly positioned.
The UR will record the results of the verification carried out on the CRF and will leave its position in the operating room at the FR. Finally, the correct positioning of the LDLT will be verified with FOB from the FR and eventually repositioned. The bronchoscope will be introduced into the tracheal lumen and get throw until it reaches just beyond the tracheal hole. The correct vision foresees: the carena on the sagittal plane and on the right the orifice of the right main bronchus, while on the left, the dome of the bronchial cap occupying the orifice of the left main bronchus. The final judgment of the FR will be: "correct positioning", "malposition", "critical malposition". Each researcher will not know the outcome of the verification carried out by the other 2 researchers.
Once the correct positioning of the LDLT has been verified, if necessary by the surgical requirements, the patient will be placed in lateral position and a new pulmonary exclusion test will be performed. AR, UR and FR will perform again the lung test exclusion, reporting in the CFR the results of the new evaluations. These assessments will be made by the same researchers who performed the previous assessments.
During the intra-operative phase the ventilation and maintenance of general anesthesia will be set according to the standard clinical practice and data will be reported in the appropriate section of the CFR concerning vital and ventilation parameters, the time required for pulmonary exclusion tests, any displacement of the LDLT and any surgical and non-surgical complications.
At the end of the surgical procedure, after optimization of the analgesia and according to the patient's needs, the patient will be extubated in the operating room or transfered in the the post-operative intensive care unit. The collection of clinical data will continue in the post-operative period until the hospital discharge of the patient enrolled in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare trans- thoracic ultrasound method and auscultation in left selective intubation with LDLT, considering them as an alternative to fiberoptic bronchoscope use.
Sensitivity, specificity and accuracy of ultrasound method and auscultation method as technique to verify LDLT correct placement, checked with fiberoptic bronchoscope.
Measured: Through study completion, an average of 1 years
Secondary outcomes (12)
Incidence of LDLT malpositioning
Measured: Through study completion, an average of 1 years
Incidence of LDLT displacements after lateral positioning and during surgery
Measured: Through study completion, an average of 1 years
Incidence of intra- and post-operating complications
Measured: Through study completion, an average of 1 years
Presence/absence of lung sliding throw ultrasound scan in case of correct/incorrect position of LDLT
Measured: Through study completion, an average of 1 years
Presence/absence of lung pulse throw ultrasound scan in case of correct/incorrect position of LDLT
Measured: Through study completion, an average of 1 years
Measure of diaphragmatic displacement throw ultrasound scan in spontaneous breath and in mechanical ventilation
Measured: Through study completion, an average of 1 years
Evaluation time to perform lung ultrasound scansion during lung exclusion test
Measured: Through study completion, an average of 1 years
Evaluation time to perform auscultation during lung exclusion test.
Measured: Through study completion, an average of 1 years
Evaluation time to verifing of position of LDLT with FOB
Measured: Through study completion, an average of 1 years
Incidence of ICU admission (planned or unplanned)
Measured: Through study completion, an average of 1 years
ICU and Hospital length of stay
Measured: Through study completion, an average of 1 years
Incidence of mortality
Measured: Through study completion, an average of 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start2 Apr 2019 (estimated)
- Primary completion2 Apr 2020 (estimated)
- Study completion2 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic AnesthesiaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Giovanna Bignami, University of Parma
- Investigators
- Michela Tosi, MD, Principal investigator, Azienda Ospedaliero-Universitaria di ParmaMassimo Maffezzoni, MD, Principal investigator, Università di ParmaPiercarlo Cottone, MD, Principal investigator, Università di ParmaStefania Lepori, MD, Principal investigator, Università di ParmaValentina Bellini, MD, Principal investigator, Università di Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912311
- Sponsor's protocol ID
- ALFIO2019
- Acronym
- ALFIO
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Diagnostic Performances of Auscultation and Ultrasonography Respect of Fiberoptic Bronchoscopy in the Valuation of Positioning of Endotracheal Double-lumen Tube in Elective Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03912311
- Acronym / sponsor ID
- ALFIO / ALFIO2019
- Conditions
- Thoracic Anesthesia, Lung Ultrasound, Left Double-lumen Tube, Selective Bronchial Intubation, One-lung Ventilation, Auscultation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 2 Apr 2019 (estimated)
- Primary completion
- 2 Apr 2020 (estimated)
- Study completion
- 2 Jun 2020 (estimated)
- First posted
- 11 Apr 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.
The study will be to demonstrate that, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) in OR is more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. The aim of the study is to demonstrate how lung ultrasound can be considered an attractive alternative to the routine use of fiberbronchoscope as a first line diagnostic tool to verify the correct position of left double lumen tube.
Detailed description
Most procedures in thoracic surgery require exclusion from ventilation of the lung undergoing surgery. One-lung ventilation (OLV), it is obtained mainly through the placement of a bi-lumen tube (DLT) in the patient's airway. A frequent complication that occurs during OLV it's unrecognized bad positioning of the DLT which can lead to serious complications such as hypoventilation, hypoxemia, not optimal collapse of the operated lung and damage to the trachea or main bronchi.
The latest SIAARTI recommendations (2009) advocate in all patients use of fiberbronchoscope (FOB) to control and correct the positioning of the DLT (gold standard) after the orotracheal intubation and after the positioning in lateral decubitus. The usual clinical practice expects to performing lung exclusion tests by auscultation of the 2 hemithorax in succession. But the scientific evidence shows how this practice has a poor sensitivity and specificity in assessing the correct positioning of the left DLT (LDLT). From literature, as from everyday clinical experience, it is known that FBS cannot always be performed Finally, the research wants to shed light how the fiberoptic bronchoscopy (FBS) is an invasive maneuver that is not free from serious complications (mucosal lesions and infections).
Ultrasound (US) over the last 15 years has made an important contribution to the assessment and management of the airways. US quickly and effectively are able to show the excursion of the diaphragm and pleura, qualitative and quantitative indicators of lung expansion. If the endotracheal tube is in the correct position, a bilateral and symmetrical movement of the domes of each hemi-diaphragm (B-Mode and M-mode) can be appreciated, while in the intercostal window, the so-called "lung-sliding" will be visible. In the absence of ventilation, the diaphragmatic excursion and the "lung-sliding" will not be detectable in the explored hemi-thorax.
Although FBS remains the gold standard for controlling the correct position of LDLT under thoracic anesthesia, and is often crucial as a guide to its repositioning, from the researchers point of view, the use of FOB may not be routinely necessary in all patients, but its use could be reserved for selected cases in which the positioning itself is difficult or in case of intraoperative displacement. Primary objective is to demonstrate how, in patients undergoing elective thoracic surgery, lung ultrasound (LUS) to the operating room is a more sensitive, specific and accurate method than thoracic auscultation, for the evaluation of OLV. LUS is a non-invasive, safe and free from side effects technique that can be performed at the patient's bed. The study aims to demonstrate how LUS can be considered an attractive alternative to the routine use of FOB as a first line diagnostic tool to verify the correct position of LDLT.
For each surgical procedure 3 researchers will participate, each with a specific independent role: the auscultation researcher (AR), which will have the task of performing the oral-tracheal intubation and auscultation with phonendoscope pre-and post-induction of general anesthesia and after positioning the patient in lateral decubitus; the ultrasound researcher (UR), i.e. the anesthesiologist who will perform the pre- and post-induction of the AG ultrasound evaluation and after positioning the patient in lateral decubitus; the Fiberscope Researcher (FR), whom will perform the fibrobroncoscopic verification of the LDLT at the end of the clinical and ultrasound assessment and after the positioning in lateral position. He will reposition the endotracheal tube in case of mal positioning or intra-operative displacement of the same.
Upon the arrival of the patients in the operating room, and after applying the standard operative monitoring for the planned surgery, the AR will perform a preliminary thoracic auscultation, in order to verify the presence of normal lung sounds in spontaneous breathing. The UR will perform a preliminary thoracic ultrasound scanning, in order to verify the presence of long sliding (LS) and diaphragmatic displacement (DD). Then, after the positioning of adequate venous accesses and eventually a medium-thoracic peridural catheter, AR will proceed to induce general anesthesia. Patients will undergo video-thoracoscopy or thoracotomy operations that require mono-pulmonary ventilation (OLV) for each part or for the entire duration of the operation. The choice of the appropriate LDLT size will be made on the basis of Brodsky's anthropometric criteria. After sedation and curarization, direct laryngoscopy will be performed with a Macintosh blade and patients will be intubated with a left bi-lumen (LDLT) Carlens or Robertshaw tube by the AR, after that he will also perform auscultation. After inflating the tracheal cuff and verifying the symmetricity of the vesicular murmure on both pulmonary fields in two pre-established points per side (apex = II-III intercostal space on the hemiclavicular; base = V intercostal space on the middle axilla), the bronchial cuff will be inflated and the auscultation repeated by first clamping the tracheal lumen and then the bronchial lumen. If the LDLT is correctly positioned the MV will be present at the apex and base of the ventilated lung and absent in the contralateral points of the excluded lung. Otherwise the LDLT will be considered wrongly positioned and the AR will have 3 attempts to reposition the device. The AR will record the results of the verification carried out on the CRF and will leave its role in the OR at the UR. The latter, using a 6-13 MHz linear ultrasound probe, will evaluate, in B-mode and M-mode, the presence / absence of the LS and the LP at the level of the II-III intercostal space on the hemiclavicular, while with a convex ultrasound probe 3,5-5 MHz placed orthogonally to the costal arch on the anterior axillary line, the diaphragmatic displacement will be searched and measured. The bi-lumen tube will be considered correctly positioned in the presence of LS and DD in the ventilated lung and in their absence in the excluded lung. Otherwise the LDLT will be considered wrongly positioned.
The UR will record the results of the verification carried out on the CRF and will leave its position in the operating room at the FR. Finally, the correct positioning of the LDLT will be verified with FOB from the FR and eventually repositioned. The bronchoscope will be introduced into the tracheal lumen and get throw until it reaches just beyond the tracheal hole. The correct vision foresees: the carena on the sagittal plane and on the right the orifice of the right main bronchus, while on the left, the dome of the bronchial cap occupying the orifice of the left main bronchus. The final judgment of the FR will be: "correct positioning", "malposition", "critical malposition". Each researcher will not know the outcome of the verification carried out by the other 2 researchers.
Once the correct positioning of the LDLT has been verified, if necessary by the surgical requirements, the patient will be placed in lateral position and a new pulmonary exclusion test will be performed. AR, UR and FR will perform again the lung test exclusion, reporting in the CFR the results of the new evaluations. These assessments will be made by the same researchers who performed the previous assessments.
During the intra-operative phase the ventilation and maintenance of general anesthesia will be set according to the standard clinical practice and data will be reported in the appropriate section of the CFR concerning vital and ventilation parameters, the time required for pulmonary exclusion tests, any displacement of the LDLT and any surgical and non-surgical complications.
At the end of the surgical procedure, after optimization of the analgesia and according to the patient's needs, the patient will be extubated in the operating room or transfered in the the post-operative intensive care unit. The collection of clinical data will continue in the post-operative period until the hospital discharge of the patient enrolled in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent elective thoracic surgery (video-assisted thoracic surgery or open thoracotomy) requiring lung isolation and endotracheally intubation by left double lumen tube
Key inclusion criteria (3 listed)
- Signed informed consent
- Age > 18 years
- Patients who underwent elective thoracic surgery (video-assisted thoracic surgery or open thoracotomy) requiring lung isolation and endotracheally intubation by LDLT
Key exclusion criteria (10 listed)
- Not signed informed consent
- Age < 18 years
- Previous history of thoracic surgery
- Planned use of right double lumen tube
- Pleural diseases: pleural spill, pneumothorax, mesothelioma, previous pleurodesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare trans- thoracic ultrasound method and auscultation in left selective intubation with LDLT, considering them as an alternative to fiberoptic bronchoscope use.
Time frame: Through study completion, an average of 1 years
Sensitivity, specificity and accuracy of ultrasound method and auscultation method as technique to verify LDLT correct placement, checked with fiberoptic bronchoscope.
12 secondary outcomes
Incidence of LDLT malpositioning
Time frame: Through study completion, an average of 1 years
Incidence of LDLT displacements after lateral positioning and during surgery
Time frame: Through study completion, an average of 1 years
Incidence of intra- and post-operating complications
Time frame: Through study completion, an average of 1 years
Presence/absence of lung sliding throw ultrasound scan in case of correct/incorrect position of LDLT
Time frame: Through study completion, an average of 1 years
Presence/absence of lung pulse throw ultrasound scan in case of correct/incorrect position of LDLT
Time frame: Through study completion, an average of 1 years
Measure of diaphragmatic displacement throw ultrasound scan in spontaneous breath and in mechanical ventilation
Time frame: Through study completion, an average of 1 years
Evaluation time to perform lung ultrasound scansion during lung exclusion test
Time frame: Through study completion, an average of 1 years
Evaluation time to perform auscultation during lung exclusion test.
Time frame: Through study completion, an average of 1 years
Evaluation time to verifing of position of LDLT with FOB
Time frame: Through study completion, an average of 1 years
Incidence of ICU admission (planned or unplanned)
Time frame: Through study completion, an average of 1 years
ICU and Hospital length of stay
Time frame: Through study completion, an average of 1 years
Incidence of mortality
Time frame: Through study completion, an average of 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
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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.
Michela Tosi, MD principal investigator
Azienda Ospedaliero-Universitaria di Parma
Massimo Maffezzoni, MD principal investigator
Università di Parma
Piercarlo Cottone, MD principal investigator
Università di Parma
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 Thoracic Anesthesia and Lung Ultrasound, run by University of Parma at 1 site in Italy.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Apr 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena G. Bignami, MD professor (+390521703567, elenagiovanna.bignami@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare trans- thoracic ultrasound method and auscultation in left selective intubation with LDLT, considering them as an alternative to fiberoptic bronchoscope use. (time frame: Through study completion, an average of 1 years). 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 Apr 2019.