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Role of Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube Placement in Thoracic Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04740385
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

Study Description
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Brief Summary:
to assess the efficacy of lung ultrasound versus conventional auscultation method and fiberoptic bronchoscopy in confirmation of double lumen tube position

Condition or disease Intervention/treatment
Diagnostic Accuracy Diagnostic Test: Lung auscultation Device: Fiberoptic bronchoscopy Device: Lung Ultrasound

Detailed Description:
Confirmation of double lumen tube position by auscultation followed fiberoptic bronchoscopy then lung ultrasound. After double lumen intubation all patient tube position will be confirmed using auscultation then fiberoptic bronchoscopy then lung ultrasound
Study Design
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Study Type : Observational
Estimated Enrollment : 37 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Role of Transthoracic Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : February 25, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Lung cancer patients
Correct position of double lumen endotracheal tube will be assessed using lung sonography, routine chest auscultation and fiberoptic brochoscopy
 Diagnostic Test: Lung auscultation
auscultation of air entry through chest wal

Device: Fiberoptic bronchoscopy
Checking correct double lumen position through direct vision using fiberoptic bronchoscopy

Device: Lung Ultrasound
real time visualization of air entry to the lungs using trans-thoracic lung ultrasound


Outcome Measures
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Primary Outcome Measures :
  1. sensitivity and specificity of lung ultrasound in confirmation of correct double lumen position [ Time Frame: 5 minutes ]
    real time visulaization of air entry to the lung


Secondary Outcome Measures :
  1. procedural time [ Time Frame: 5 minutes ]
    time taken to confirm tube position


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
lung cancer patients undergoing thoracic surgeries requiring double lumen intubation
Criteria

Inclusion Criteria:

  • patients scheduled for surgeries under general anesthesia requiring double lumen endotracheal intubation
  • ASA I-II

Exclusion Criteria:

  • patient refusal
  • patients not meeting the inclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740385


Contacts
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Contact: Walaa Y Elsabeeny, MD 01007798466 ext 002 walaa.elsabeeny@nci.cu.edu.eg

Locations
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Egypt
Department of anesthesia and pain medicine. National Cancer Institute Recruiting
Cairo, Egypt, 11796
Contact: Walaa Y Elsabeeny, MD    01007798466 ext +2    Walaa.elsabeeny@nci.cu.edu.eg   
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
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Principal Investigator: Walaa Y Elsabeeny, MD Lecturer
More Information
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Responsible Party: Walaa Youssef Elsabeeny, Lecturer of anesthesia and pain management, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT04740385    
Other Study ID Numbers: 202101-2P-02002
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No