Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06457763 |
| Other study ID # |
09.2022.755 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
May 29, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Marmara University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The aim of this study was to determine the accuracy and practicality of ultrasound in the
selection of double lumen tube and whether the complications that may occur intraoperatively
and postoperatively can be reduced.
Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube
placement for single lung ventilation will be included in this study. Patients with a history
of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the
Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation,
and patients with previously known hoarseness and chronic cough will not be included in the
study. Patients who accept the study will be randomly assigned to one of the anaesthesia
groups including ultrasound group (Group 1) and classical method (Group 2).
Randomisation will be in a 1:1 ratio and will be done by closed envelope method.
Description:
The aim of this study was to determine the accuracy and practicality of ultrasound in the
selection of double lumen tube and whether the complications that may occur intraoperatively
and postoperatively can be reduced.
In thoracic surgery, single lung ventilation is one of the most challenging airway and
ventilation methods for anaesthetists. Bronchial blockers and double lumen tubes are the
tools used to isolate the lung in single lung ventilation and double lumen tubes are used
more frequently. Size is important when choosing a double lumen tube. There is no definite
rule when choosing the tube size. When selecting the size of the double lumen tube, there is
a classical method selected according to the gender and height of the patient. However, due
to anatomical differences between individuals; inappropriate tube sizes may be selected and
this may lead to consequences such as tracheabronchial injury and insufficient deflation of
the lungs.
The use of ultrasound can provide rapid assessment of airway anatomy in the operating
theatre, intensive care unit and emergency department. Ultrasound is a suitable tool for the
evaluation of the subglottic airway confirmed by computed tomography. The use of ultrasound
requires less training and the patient does not need to be fully immobilised and sedated.
There is a correlation between the diameter of the external trachea measured by ultrasound
just above the sternoclavicular junction and the diameter of the left main bronchus measured
by computed tomography scan.
Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube
placement for single lung ventilation will be included in this study. Patients with a history
of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the
Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation,
and patients with previously known hoarseness and chronic cough will not be included in the
study. Patients who accept the study will be randomly assigned to one of the anaesthesia
groups including ultrasound group (Group 1) and classical method (Group 2).
Randomisation will be in a 1:1 ratio and will be done by closed envelope method. A paper with
the name of one of the two groups will be placed in the envelopes beforehand and the
envelopes will be closed and mixed. For each patient, a closed envelope will be drawn
randomly before the procedure and the procedures will be performed according to the group
indicated on the paper.
Intraoperative anaesthesia management Before induction of anaesthesia, the patients in this
group will be placed in the supine position with the head in slight extension and the outer
diameter of the trachea will be measured with a linear probe 0.5 cm above the
sternoclavicular joint by placing the ultrasound transverse and the patient will be intubated
by selecting a left double lumen tube suitable for this measurement.
In the classical method group (Group2), 37 fr left double lumen tube was selected for female
patients taller than 160 cm and 35 fr left double lumen tube was selected for patients
shorter than 160 cm. For male patients, a 41 fr left double lumen tube was selected for
patients taller than 170 cm and a 39 fr tube was selected for men shorter than 170 cm.
Anaesthesia induction was performed with propofol (2 mg/kg), remifentanil 1mcg/kg, and
rocuronium 0.6 mg/kg under standard monitoring (ECG, non-invasive blood pressure, and finger
prick oxygen saturation). In both groups of patients, after direct laryngoscopy and
visualisation of the vocal cords, the tip of the left double lumen tube was rotated 90
degrees counterclockwise past the vocal cords and pushed until resistance was felt. The depth
of the left double lumen tube was determined as 12+ patient height (cm)/10 cm from the tooth
level and then the location of the tube was confirmed with a fibreoptic bronchoscope.
