EIT Based Regional Lung Ventilation in Minimally Invasive Cardiac Surgery

NCT04985513 | Completed

• 1 other identifier: 05-2021-156
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Electrical impedance tomography (EIT) is a non-invasive, radiation-free imaging technique that measures local pulmonary ventilation and ventilation distribution through potential changes on the skin surface of the chest wall during the respiratory cycle. Recently, a global inhomogeneity (GI) index has been proposed and used to quantify the distribution of tidal volume in the lungs. Currently, there are research results showing that ventilation improves postoperative oxygenation and gas exchange when ventilation is applied during CPB, but the evidence for long-term prognosis is lacking. In this study, researchers performed electrical impedance tomography in the intensive care unit immediately after surgery on patients who had undergone endotracheal tube extubation in the operating room immediately after completing minimally invasive cardiac surgery by collapsing the right lung through right minimal thoracotomy. The purpose of this study is to measure local pulmonary ventilation and ventilation distribution using this method and to find the optimal left lung ventilation method during minimally invasive cardiac surgery based on this. Identifying the difference in postoperative pulmonary ventilation disorders and functional regional ventilation according to the pulmonary ventilation strategy at the time of CPB in minimally invasive cardiac surgery can help predict the risk of pulmonary complications and improve the prognosis of patients after surgery.

Conditions

Patients Who Underwent CPB for MICS

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary ventilation disorders

  Confirmation of postoperative pulmonary ventilation disorders according to the lung ventilation strategy at the time of cardiopulmonary bypass in minimally invasive cardiac surgery

  after ICU transferring (up to 1hour)

Secondary Outcomes (1)

• incidence of postoperative pulmonary complications

  during ICU hospitalization (up to 7 days)

Study Arms (2)

Group N

NO INTERVENTION

Stopping ventilation during cardiopulmonary bypass

Group V

ACTIVE COMPARATOR

Ventilation was performed using an inhaled oxygen fraction of 20% and a tidal volume of 5ml/kg at the time of cardiopulmonary bypass.

Procedure: Ventilation during cardiopulmonary bypass

Interventions

Ventilation during cardiopulmonary bypass PROCEDURE

Ventilation was performed using an inhaled oxygen fraction of 20% and a tidal volume of 5ml/kg at the time of cardiopulmonary bypass.

Group V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years of age
• Patients who underwent one lung ventilation using a bronchial blocker for minimally invasive cardiac surgery
• If there is no atelectasis on chest X-ray or chest computed tomography performed before surgery

You may not qualify if:

• If there is evidence of atelectasis, pneumonia, or lung disease that can reduce lung volume in a chest X-ray examination or chest computed tomography performed before surgery
• Patients scheduled for sternotomy
• If there is a skin disease in the chest that requires EIT measurement
• If there is a plan to transfer to the intensive care unit while maintaining the endotracheal tube

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

Related Publications (1)

• Yeo HJ, Kim HY, Je HG, Kim HJ, Park S, Yoon JP, Ju MH, Lim MH, Lee CH. Electrical impedance tomography-based evaluation of regional lung ventilation according to ventilation strategy during cardiopulmonary bypass in minimally invasive cardiac surgery: a prospective randomized controlled trial. J Thorac Dis. 2025 Jun 30;17(6):3912-3923. doi: 10.21037/jtd-24-1877. Epub 2025 Jun 23.

  PMID: 40688333 DERIVED

Study Officials

• Hyung Gon Je

  School of Medicone, Pusan National University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 2, 2021
• Study Start: August 2, 2021
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

KR (1)