Effectiveness of Lung Sono in One-lung Ventilation

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03770793
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 33.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
One Lung Ventilation	Procedure: Lung-sono guided	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Ultrasound-guided Alveolar Recruitment in Thoracic Surgery With One-lung Ventilation
• Actual Study Start Date: Dec 7, 2018
• Actual Primary Completion Date: May 7, 2019
• Actual Study Completion Date: May 7, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lung-sono guided Before starting one-lung ventilation, alveolar recruitment is performed under the examination with ultrasound. Find the minimal airway pressure that actually starts to resolve the observed atelectasis. Repeat alveolar recruitment with the minimal pressure untill the atlelectasis is not visible.	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.
No Intervention: Conventional Before starting one-lung ventilation, alveolar recruitment is performed with the pressure of 30mmHg for 10 seconds which is a conventional method.

Outcome Measures

Primary Outcome Measures

1. Incidence of desaturation [intraoperative]

   SpO2<95%

2. P/F ratio [30 minutes after one-lung ventilation]

   PaO2/FiO2 ratio

Secondary Outcome Measures

1. Lung ultrasound score [just after anesthesia induction, end of surgery]

   Lung ultrasound score of atelectasis

2. Alveolar dead space [30 minutes after one-lung ventilation]

   (PaCO2-PetCO2)xVt/PaCO2

3. Pulmonary complications [intraoperative, during hospital stay(an average of 3 days)]

   respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Study Chair: Jeong-Hwa Seo, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Jeong-Hwa Seo, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03770793
• Other Study ID Numbers: JHSeo_LungSono
• First Posted: Dec 10, 2018
• Last Update Posted: Nov 12, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jeong-Hwa Seo, Professor, Seoul National University Hospital: One lung ventilation; Lung ultrasound; Alveolar recruitment

Study Results

No Results Posted as of Nov 12, 2020