AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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.

Fathy Tash, professor contact

20226857539

REC-FAMSU@med.asu.edu.eg

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 groups in NCT06383156
Study groupRoleWhat they receive
AuscultationActive comparatorcorrect position of LDLT during single lung ventilation will be confirmed by clinical methods.
Receives: Device: Double lumen endotracheal tube
UltrasoundActive comparatorcorrect position of LDLT during single lung ventilation will be confirmed when lung USG revealed correct lung isolation
Receives: Device: Double lumen endotracheal tube
FluoroscopyActive comparatorcorrect 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.

  1. 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)
  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.

  1. First posted25 Apr 2024
  2. Study start15 Jun 2024 (estimated)
  3. Primary completion18 Dec 2024 (estimated)
  4. Study completion1 Feb 2025 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in