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Ultrasound for Double Lumen Endotracheal Tube

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556853
Recruitment Status : Terminated (The Thoracic Surgery Department has almost stopped completely its surgical activities and the completion of the study doesn't seem to be feasible.)
First Posted : September 22, 2015
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Georgios Kotsovolis, 424 General Military Hospital

Brief Summary:
The patients will be allocated to 2 groups: the ultrasound group and the clinical group. The correct position of the double lumen tube will be determined by ultrasound (Sonoscape S6®) for the patients of the one group (group U) and by clinical examination for the patients of the other group (group C). The correct placement will be verified by bronchoscopy (Pentax®). The two methods will be compared in terms of sensitivity and specificity. The main purpose of the study is to determine if the ultrasound can be used for determination of the correct placement of the left sided double lumen endotracheal tube

Condition or disease Intervention/treatment Phase
Lung Ultrasound Device: Determination of tube position by ultrasound. Other: Determination of tube position by auscultation. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Comparison Between Ultrasound and Clinical Assessment of the Correct Positioning of Left Double Lumen Endotracheal Tube
Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Ultrasound
Determination of correct placement of the double lumen tube by lung ultrasound.
Device: Determination of tube position by ultrasound.
After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by ultrasound (Sonoscape S6®). The ultrasound probe will be placed between the 2nd and 3rd intercostal space at the level of the midclavicular line parallel to the line. The probe will be slightly moved or tilted until the pleural line is identified. If lung sliding is identified then the ventilation of the lung will be considered adequate. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.

Active Comparator: Clinical
Determination of correct placement of the double lumen tube by clinical examination.
Other: Determination of tube position by auscultation.
After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by auscultation of the upper lung fields. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.




Primary Outcome Measures :
  1. Correct position of the tube (yes/no). [ Time Frame: Within an average of 5 minutes after the placement of the double lumen tube ]
    The anesthesiologist who will place the left-sided double lumen tube will determine if the position of the tube is correct according to the ultrasound or clinical findings.

  2. Correct position of the tube by bronchoscopy (yes/no). [ Time Frame: Within an average of 10 minutes after the placement of the double lumen tube. ]
    After the assessment of the tube's position, a second anesthesiologist will verify the position of the tube by bronchoscopy.


Secondary Outcome Measures :
  1. Time needed [ Time Frame: Within an average of 10 minutes after the placement of the double lumen tube. ]
    The total time passed from the beginning of laryngoscopy until the final verification of the tube's position.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery requiring placement of double-lumen endotracheal tube.
  • ASA 1-3

Exclusion Criteria:

  • History of difficult or impossible intubation.
  • Clinical findings of possible difficult intubation according to the standard preoperative airway assessment.
  • Impossible placement of a double lumen tube

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): NCT02556853


Locations
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Greece
Anesthesia department; 424 Army General Hospital
Thessaloniki, Greece, 56429
Sponsors and Collaborators
424 General Military Hospital
Publications:
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Responsible Party: Georgios Kotsovolis, Doctor, 424 General Military Hospital
ClinicalTrials.gov Identifier: NCT02556853    
Other Study ID Numbers: 14074
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Keywords provided by Georgios Kotsovolis, 424 General Military Hospital:
Ultrasound
Double lumen tube