NCT03770793

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

December 6, 2018

Last Update Submit

November 9, 2020

Conditions

Keywords

One lung ventilationLung ultrasoundAlveolar recruitment

Outcome Measures

Primary Outcomes (2)

  • Incidence of desaturation

    SpO2\<95%

    intraoperative

  • P/F ratio

    PaO2/FiO2 ratio

    30 minutes after one-lung ventilation

Secondary Outcomes (3)

  • Lung ultrasound score

    just after anesthesia induction, end of surgery

  • Alveolar dead space

    30 minutes after one-lung ventilation

  • Pulmonary complications

    intraoperative, during hospital stay(an average of 3 days)

Study Arms (2)

Lung-sono guided

EXPERIMENTAL

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

Conventional

NO INTERVENTION

Before starting one-lung ventilation, alveolar recruitment is performed with the pressure of 30mmHg for 10 seconds which is a conventional method.

Interventions

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.

Lung-sono guided

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position

You may not qualify if:

  • Patients who refuse to agree
  • Previous lung surgical history
  • History of pneumothorax or bullae
  • Severe cardiopulmonary disease, COPD
  • Operation time \< 1hr

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 29309282BACKGROUND
  • Kim BR, Lim L, You J, Yoon S, Park JB, Bahk JH, Seo JH. Effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery with one-lung ventilation: a randomized-controlled trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf204. doi: 10.1093/ejcts/ezaf204.

Study Officials

  • Jeong-Hwa Seo, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 10, 2018

Study Start

December 7, 2018

Primary Completion

May 7, 2019

Study Completion

May 7, 2019

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations