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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03770793
Other study ID # JHSeo_LungSono
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2018
Est. completion date May 7, 2019

Study information

Verified date November 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with one-lung ventilation(OLV).


Description:

One-lung ventilation(OLV) is essential in thoracic surgery for patient safety and better surgical view. However, pulmonary complications such as hypoxemia may be caused by OLV which might be preventable with adequate alveolar recruitment and positive end-expiratory pressure(PEEP). Alveolar recruitment has been performed with conventional methods without diagnostic tools in clinical setting. Ultrasound is a non-invasive, radiation-free device with high accuracy for the diagnosis of lung atelectasis. There are a few reports regarding the usefulness of lung ultrasound in other surgeries, but not in thoracic surgeries with OLV. Thus, investigators designed a study to observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with OLV.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date May 7, 2019
Est. primary completion date May 7, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position Exclusion Criteria: - Patients who refuse to agree - Previous lung surgical history - History of pneumothorax or bullae - Severe cardiopulmonary disease, COPD - Operation time < 1hr

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Lung-sono guided
The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil. In the intervention group, alveolar recruitment is performed to the non-surgical side of lung under examination with ultrasound just after anesthesia induction. During the gradual increment in the pressure of recruitment, the anesthesiologist can find the opening pressure that means the minimal pressure at which observed atelectasis starts to disappear. Then, alveolar recruitment is performed with the opening pressure until the atelectasis is not visible.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Song IK, Kim EH, Lee JH, Kang P, Kim HS, Kim JT. Utility of Perioperative Lung Ultrasound in Pediatric Cardiac Surgery: A Randomized Controlled Trial. Anesthesiology. 2018 Apr;128(4):718-727. doi: 10.1097/ALN.0000000000002069. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of desaturation SpO2<95% intraoperative
Primary P/F ratio PaO2/FiO2 ratio 30 minutes after one-lung ventilation
Secondary Lung ultrasound score Lung ultrasound score of atelectasis just after anesthesia induction, end of surgery
Secondary Alveolar dead space (PaCO2-PetCO2)xVt/PaCO2 30 minutes after one-lung ventilation
Secondary Pulmonary complications respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis intraoperative, during hospital stay(an average of 3 days)
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