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Effectiveness of Lung Sono in One-lung Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03770793
Recruitment Status : Completed
First Posted : December 10, 2018
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jeong-Hwa Seo, Seoul National University Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 7, 2018
Actual Primary Completion Date : May 7, 2019
Actual Study Completion Date : May 7, 2019
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence of desaturation [ Time Frame: intraoperative ]
    SpO2<95%

  2. P/F ratio [ Time Frame: 30 minutes after one-lung ventilation ]
    PaO2/FiO2 ratio


Secondary Outcome Measures :
  1. Lung ultrasound score [ Time Frame: just after anesthesia induction, end of surgery ]
    Lung ultrasound score of atelectasis

  2. Alveolar dead space [ Time Frame: 30 minutes after one-lung ventilation ]
    (PaCO2-PetCO2)xVt/PaCO2

  3. Pulmonary complications [ Time Frame: intraoperative, during hospital stay(an average of 3 days) ]
    respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770793


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Jeong-Hwa Seo, PhD Seoul National University Hospital
More Information
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Publications:

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Responsible Party: Jeong-Hwa Seo, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03770793    
Other Study ID Numbers: JHSeo_LungSono
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020

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