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Completed

NCT Number: NCT03770793

Effectiveness of Lung Sono in One-lung Ventilation

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

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Key information

Conditions

One Lung Ventilation

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung-sono guided

Procedure

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2018
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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