Effectiveness of Lung Sono in One-lung Ventilation

One Lung Ventilation Clinical Trial

Official title:

Effectiveness of Ultrasound-guided Alveolar Recruitment in Thoracic Surgery With One-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770793
• Other study ID #: JHSeo_LungSono
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• One Lung Ventilation

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)