Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06064773 |
| Other study ID # |
2021/17-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
December 1, 2021 |
Study information
| Verified date |
September 2023 |
| Source |
Dokuz Eylul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
BACKGROUND: The aim of this study is to evaluate the confirmation of double lumen tube
placement with thoracic Ultrasound (USG) in thorax surgery operations with one lung
ventilation.
METHODS: In this prospective and observational study, 130 patients aged between 18-65 years
in ASA (American Society of Anesthesiology) I-III risk class who will undergo thoracic
surgery with the application of single-lung ventilation were included in the study. A
double-lumen endobronchial tube was placed in the patients blindly. One-lung ventilation
(OLV) was confirmed by thoracic USG by the anesthesiologist. The patient's demographic data,
rapid clinical evaluation and USG data results, and intraoperative surgeon satisfaction were
recorded.
Description:
This prospective observational study was carried out in the Department of Anesthesiology and
Reanimation, with the permission of the Ethics Committee of Dokuz Eylul University Medical
Faculty Hospital (Ethics Committee Decision No:2021/17-04). Between 01.07.2021 and
01.12.2021, cases requiring single-lung ventilation by thoracic surgery in the operating room
of Dokuz Eylul University Faculty of Medicine were included in the study.
Over 18 years old, patients who need OLV and undergoing elective surgery was determined as
inclusion criteria. Furthermore patients did not want to participate in the study, with a
narrowed trachea and/or a narrowed main bronchus that does not allow DLT placement, with
endobronchial lesion in the main bronchus, with subcutaneous emphysema, having a chest tube
due to pneumothorax, with pleural effusion, having a history of pleurodesis, bullous lung,
patients with a history of tracheostomy and patients who will undergo emergency surgery
determined as exclusion criteria for the study.
On the day of surgery, all patients were premedicated after a 20 G cannula was placed on the
back of the hand before they were taken to the operating room. Routine anesthesia induction
was performed after preoxygenation with 100% O2 for 5 minutes by monitoring 3-lead
electrocardiography, peripheral oxygen saturation and noninvasive blood pressure in the
patients who were taken to the operating room. After anesthesia induction, patients underwent
double lumen tube intubation and after confirming single lung ventilation with thoracic USG
(GE Healthcare LOGIQ e), tube location was confirmed by fiberoptic bronchoscopy (FOB) and
clinical evaluation and recorded. Slip sign on USG was evaluated with M-mode imaging in the
right and left lower quadrants of the thorax at the level of the costophrenic angles. When
the bronchial lumen was clamped, the tube was considered to be positioned correctly if the
left shift sign was selectively lost.
Age, gender, body mass index (BMI), AmericanSociety of Anesthesiologists score,
co-morbidities (Hypertension, diabetes mellitus, malignancy, chronic obstructive pulmonary
disease) duration of surgery, clinical and FOB evaluation results of the patients included in
the study, in the supine position and in the lateral position during the intraoperative
period. The determined DLT malpositions and the manipulations performed to correct them and
the results of the evaluation with the thorax USG method, as well as the intraoperative
surgeon satisfaction were recorded by the doctor who followed the case.
