Endotracheal Tube Wrongly Placed During Anesthetic ProcedureNCT06383156
The Use of Lung US, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT : A Comparative Study
A study testing Double lumen endotracheal tube in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Ain Shams University.
Trial summary
The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- Double lumen endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 1 Feb 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60
- Physical status: ASA 1-3 that were scheduled for elective thoracic surgery and who required a left-sided double lumen tube (LDLT) during anesthesia after taking written and informed Consent.
Who cannot join
- Anticipated difficult intubation.
- Tracheostomy tube.
- Concurrent pneumothorax.
- Pleural effusion and emphysema.
- History of pleurodesis, and/or abnormal pulmonary function test (forced expiration volume in one second, total lung capacity, or forced vital capacity < 50% of the predicted values).
- Body mass index more than 35
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Lung Ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided Double Lumen Tube: A Comparative Study
The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries.
Read the detailed description
A double - blinded randomized controlled trial, After Approval is obtained from research ethics committee of anesthesia and intensive care department, faculty of medicine, Ain Shams University. the study done over18 months. we included patients age between 18 and 60 years old, Physical status according to American Society Anesthesiology 1-3 that will be scheduled for elective thoracic surgery and who required a left-sided double lumen tube (LDLT) during anesthesia after taking written and informed consent. we excluded anticipated difficult intubation, tracheostomy tube, concurrent pneumothorax, pleural effusion, history of pleurodesis, and/or abnormal pulmonary function test (forced expiration volume in one second, total lung capacity, or forced vital capacity < 50% of the predicted values), BMI > 35 kg/m2 , or < 18kg/m2.
a sample size of at least 30 patients per each group of patients undergoing elective thoracic surgery will achieve 100% power, at alpha error 0.05, by using power analysis and sample size software (PASS 15) (Version 15.0.10) for sample size calculation.
Patients will be randomly allocated into 3 groups utilizing computer generated list for allocation and the group assignments will be placed in a closed envelope.
In Group A, the correct position of LDLT during single lung ventilation will be confirmed by clinical methods.
In Group B, the correct position of LDLT during single lung ventilation will be confirmed when lung USG revealed correct lung isolation.
In Group C, the correct position of LDLT during single lung ventilation will be confirmed when fluoroscopy visualizes the left bronchial cuff and lumen in left main bronchus.
In the three groups correct position of LDLT will be confirmed if there is correct lung isolation by fiberoptic bronchoscopy.
On arrival in the operating room, standard monitoring of the patients' electrocardiogram, pulse oximetry, capnography, and non-invasive blood pressure will be allowed. After preoxygenation with 100% oxygen for 5 minutes, Induction of general anesthesia (GA) was performed by propofol 2 mg/kg and fentanyl 2 μg/kg IV. Laryngoscopy will be facilitated by rocuronium 0.5 mg/kg followed by intubation by DLT according to sex and height. General anesthesia will be maintained using isoflurane 1 - 1.5 Vol.% through positive pressure mechanical ventilation and atracurium top-up doses. All the DLT inserted will be left-sided. Following passage of the endobronchial cuff through the vocal cords, the DLT will be rotated 90 degrees counterclockwise and gently advanced for 28 to 30 cm according to the anesthesiologist's decision and with consideration of the patient's height. Following intubation, both the tracheal and bronchial cuffs will be inflated, and the initial depth of insertion will be recorded.
In group A, assessment of the LDLT position using chest auscultation of the upper and lower chest zones on both sides after tracheal cuff will be initially inflated. This will be followed by inflation of the bronchial cuff and repeated auscultation of the same regions, first with the tracheal lumen clamped and finally with the bronchial lumen clamped.
Correct intubation of the DLT will be confirmed by the existence of symmetrical bilateral lung sounds prior to clamping of the tracheal lumen, then by a reduction in the whole sound of the right lung and the appearance of symmetrical upper and lower lung sounds in the left lung following tracheal lumen clamping. This will be followed by a reduction in the whole sound of the left lung and the appearance of symmetrical upper and lower lung sounds in the right lung following bronchial lumen clamping.
In group B, LUS examination will be performed on both sides of the anterior and lateral chest wall on four quadrants bilaterally in the supine position. LUS scanning will be done in eight areas. The chest areas will be divided on each side into two anterior and two lateral areas. Anterior areas will be outlined from the sternum to the anterior axillary line, while the lateral areas will be from the anterior to the posterior axillary line. Each anterior and lateral area will be further divided into upper and lower areas from the clavicle to the second-third intercostal spaces and from the third space to the diaphragm. The correct position of the DLT will be confirmed with a loss of lung sliding sign on the same clamped lumen side and emergence of lung pulse sign.
In group C, The fluoroscopic device is set to pulsing X-ray beam (1 image/second), low dose, and maximum collimation. The patient is placed as close as possible to the image intensifier. These adjustments resulted in a reduction of absorbed doses. When an incorrect position is encountered after the fluoroscopy, the double lumen tube is relocated under fluoroscopic visualization until the tracheal lumen becomes just above the carina, left bronchial cuff and lumen become in left main bronchus.
In three groups final confirmation of the LDLT position will be done by flexible bronchoscope by blinded expert staff.
The correct DLT placement criteria: (1) the tracheal rings are seen anteriorly and the muscular stria posteriorly, (2) the bronchial cuff is seen below the carina and just above the left bronchus, (3) the tip of the tube is positioned just above the secondary carina through the bronchial lumen.
The incorrect DLT placement criteria: (1) absence of the tracheal rings (esophageal or bronchial intubation), (2) too shallow, defined as more than 50 % of the right bronchus opening is obscured by the bronchial cuff, (3) too deep, defined as either the bronchial cuff after inflation was totally unseen or when the tip of the bronchial tube is seen under the secondary carina.
- Being tested
- Double lumen endotracheal tube
- Keywords
- Ultrasound, Clinical auscultation, Fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double lumen endotracheal tubeDevice
correct position of LDLT during single lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| Auscultation | Active comparator | correct position of LDLT during single lung ventilation will be confirmed by clinical methods. Receives: Device: Double lumen endotracheal tube |
| Ultrasound | Active comparator | correct position of LDLT during single lung ventilation will be confirmed when lung USG revealed correct lung isolation Receives: Device: Double lumen endotracheal tube |
| Fluoroscopy | Active comparator | correct position of LDLT during single lung ventilation will be confirmed when fluoroscopy visualizes the left bronchial cuff and lumen in left main bronchus. Receives: Device: Double lumen endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope
The findings collected by the three methods will be checked for its specificity by endobronchial bronchoscopy
Measured: 2 months after data collection
Secondary outcomes (1)
sensitivity and accuracy in confirming the position of the LDLT.
the finding collected by three methods will be checked for its sensitivity by fiberoptic bronchoscopy
Measured: 2 months after data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start15 Jun 2024 (estimated)
- Primary completion18 Dec 2024 (estimated)
- Study completion1 Feb 2025 (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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ahmed Morsy, master, Principal investigator, Anesthesia assistant lecturer ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383156
- Sponsor's protocol ID
- MD157/2023
- Status last verified
- Dec 2023
- First submitted
- 23 Dec 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lung Ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided Double Lumen Tube: A Comparative Study
- ClinicalTrials.gov ID
- NCT06383156
- Acronym / sponsor ID
- MD157/2023
- Keywords
- Ultrasound, Clinical auscultation, Fluoroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 18 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 25 Apr 2024 (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 aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries.
Detailed description
A double - blinded randomized controlled trial, After Approval is obtained from research ethics committee of anesthesia and intensive care department, faculty of medicine, Ain Shams University. the study done over18 months. we included patients age between 18 and 60 years old, Physical status according to American Society Anesthesiology 1-3 that will be scheduled for elective thoracic surgery and who required a left-sided double lumen tube (LDLT) during anesthesia after taking written and informed consent. we excluded anticipated difficult intubation, tracheostomy tube, concurrent pneumothorax, pleural effusion, history of pleurodesis, and/or abnormal pulmonary function test (forced expiration volume in one second, total lung capacity, or forced vital capacity < 50% of the predicted values), BMI > 35 kg/m2 , or < 18kg/m2.
a sample size of at least 30 patients per each group of patients undergoing elective thoracic surgery will achieve 100% power, at alpha error 0.05, by using power analysis and sample size software (PASS 15) (Version 15.0.10) for sample size calculation.
Patients will be randomly allocated into 3 groups utilizing computer generated list for allocation and the group assignments will be placed in a closed envelope.
In Group A, the correct position of LDLT during single lung ventilation will be confirmed by clinical methods.
In Group B, the correct position of LDLT during single lung ventilation will be confirmed when lung USG revealed correct lung isolation.
In Group C, the correct position of LDLT during single lung ventilation will be confirmed when fluoroscopy visualizes the left bronchial cuff and lumen in left main bronchus.
In the three groups correct position of LDLT will be confirmed if there is correct lung isolation by fiberoptic bronchoscopy.
On arrival in the operating room, standard monitoring of the patients' electrocardiogram, pulse oximetry, capnography, and non-invasive blood pressure will be allowed. After preoxygenation with 100% oxygen for 5 minutes, Induction of general anesthesia (GA) was performed by propofol 2 mg/kg and fentanyl 2 μg/kg IV. Laryngoscopy will be facilitated by rocuronium 0.5 mg/kg followed by intubation by DLT according to sex and height. General anesthesia will be maintained using isoflurane 1 - 1.5 Vol.% through positive pressure mechanical ventilation and atracurium top-up doses. All the DLT inserted will be left-sided. Following passage of the endobronchial cuff through the vocal cords, the DLT will be rotated 90 degrees counterclockwise and gently advanced for 28 to 30 cm according to the anesthesiologist's decision and with consideration of the patient's height. Following intubation, both the tracheal and bronchial cuffs will be inflated, and the initial depth of insertion will be recorded.
In group A, assessment of the LDLT position using chest auscultation of the upper and lower chest zones on both sides after tracheal cuff will be initially inflated. This will be followed by inflation of the bronchial cuff and repeated auscultation of the same regions, first with the tracheal lumen clamped and finally with the bronchial lumen clamped.
Correct intubation of the DLT will be confirmed by the existence of symmetrical bilateral lung sounds prior to clamping of the tracheal lumen, then by a reduction in the whole sound of the right lung and the appearance of symmetrical upper and lower lung sounds in the left lung following tracheal lumen clamping. This will be followed by a reduction in the whole sound of the left lung and the appearance of symmetrical upper and lower lung sounds in the right lung following bronchial lumen clamping.
In group B, LUS examination will be performed on both sides of the anterior and lateral chest wall on four quadrants bilaterally in the supine position. LUS scanning will be done in eight areas. The chest areas will be divided on each side into two anterior and two lateral areas. Anterior areas will be outlined from the sternum to the anterior axillary line, while the lateral areas will be from the anterior to the posterior axillary line. Each anterior and lateral area will be further divided into upper and lower areas from the clavicle to the second-third intercostal spaces and from the third space to the diaphragm. The correct position of the DLT will be confirmed with a loss of lung sliding sign on the same clamped lumen side and emergence of lung pulse sign.
In group C, The fluoroscopic device is set to pulsing X-ray beam (1 image/second), low dose, and maximum collimation. The patient is placed as close as possible to the image intensifier. These adjustments resulted in a reduction of absorbed doses. When an incorrect position is encountered after the fluoroscopy, the double lumen tube is relocated under fluoroscopic visualization until the tracheal lumen becomes just above the carina, left bronchial cuff and lumen become in left main bronchus.
In three groups final confirmation of the LDLT position will be done by flexible bronchoscope by blinded expert staff.
The correct DLT placement criteria: (1) the tracheal rings are seen anteriorly and the muscular stria posteriorly, (2) the bronchial cuff is seen below the carina and just above the left bronchus, (3) the tip of the tube is positioned just above the secondary carina through the bronchial lumen.
The incorrect DLT placement criteria: (1) absence of the tracheal rings (esophageal or bronchial intubation), (2) too shallow, defined as more than 50 % of the right bronchus opening is obscured by the bronchial cuff, (3) too deep, defined as either the bronchial cuff after inflation was totally unseen or when the tip of the bronchial tube is seen under the secondary carina.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auscultation | Active comparator | Device: Double lumen endotracheal tubecorrect position of LDLT during single lung ventilation will be confirmed by clinical methods. |
| Ultrasound | Active comparator | Device: Double lumen endotracheal tubecorrect position of LDLT during single lung ventilation will be confirmed when lung USG revealed correct lung isolation |
| Fluoroscopy | Active comparator | Device: Double lumen endotracheal tubecorrect position of LDLT during single lung ventilation will be confirmed when fluoroscopy visualizes the left bronchial cuff and lumen in left main bronchus. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-60
- Physical status: ASA 1-3 that were scheduled for elective thoracic surgery and who required a left-sided double lumen tube (LDLT) during anesthesia after taking written and informed Consent.
Key exclusion criteria (6 listed)
- Anticipated difficult intubation.
- Tracheostomy tube.
- Concurrent pneumothorax.
- Pleural effusion and emphysema.
- History of pleurodesis, and/or abnormal pulmonary function test (forced expiration volume in one second, total lung capacity, or forced vital capacity < 50% of the predicted values).
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 |
|---|---|---|
| Double lumen endotracheal tubecorrect position of LDLT during single lung ventilation | Device | Auscultation, Fluoroscopy, Ultrasound |
Primary outcome
the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope
Time frame: 2 months after data collection
The findings collected by the three methods will be checked for its specificity by endobronchial bronchoscopy
1 secondary outcome
sensitivity and accuracy in confirming the position of the LDLT.
Time frame: 2 months after data collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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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.
ahmed Morsy, master principal investigator
Anesthesia assistant lecturer ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Double lumen endotracheal tube in people with Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Ain Shams University.
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 6 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Fathy Tash, professor (20226857539, REC-FAMSU@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope (time frame: 2 months after data collection). 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 14 May 2024.