EIT Based Regional Lung Ventilation in Minimally Invasive Cardiac Surgery

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04985513
Collaborator
(none)
60
1
2
11.9
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ventilation during cardiopulmonary bypass
N/A

Detailed Description

Minimally invasive cardiac surgery (MICS) is a safe and effective surgical method that reduces bleeding, number of reoperations, postoperative pain, and length of stay in the ICU, and promotes faster recovery compared to conventional open thoracic cardiac surgery. In general, since cardiopulmonary bypass (CPB) is used during minimally invasive cardiac surgery using right thoracotomy, both lungs can be maintained in a lung rest state. Except for 2-3 ventilations when releasing the aortic forceps during surgery, there is no ventilation at all during CPB, and both lung ventilation starts when CPB is stopped. In order to secure the surgical field of view during surgery, most anesthetists do not ventilate the right lung and maintain a collapsed state. Even during CPB, ventilation can be performed without affecting the field of vision at the surgical site. However, to date, it is not well known about the proper ventilation method for the left lung during cardiac surgery using CPB.

Pulmonary complications are major postoperative complications of minimally invasive cardiac surgery and are factors that increase postoperative pulmonary complications, such as age, preoperative lung disease, and duration of CPB, which are well-known. Failure to ventilate the entire lung field at the time of CPB may cause atelectrauma, and even if normal ventilation is performed after CPB, and shearing force from repeated collapse and expansion of the atelectasis area may occur. In addition, such atelectasis can lead to not only ventilation disorders, ventilation/perfusion imbalances, but also postoperative pneumonia and poor prognosis. In particular, since right thoracotomy is mainly performed in minimally invasive cardiac surgery, the right lung collapses through one lung ventilation from the start of the operation to the access to the surgical site or at the end of the operation to check for bleeding at the surgical site. Therefore, one lung ventilation may be required even after weaning from the CPB, which may increase the risk of atelectasis in the operated side. Depending on the ventilation of the left lung during surgery and the tidal volume (TV), it may affect postoperative atelectasis and may cause functional ventilation. This can lead to the occurrence of respiratory complications such as pneumonia after surgery, resulting in poor prognosis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Electrical Impedance Tomography Based Regional Lung Ventilation Evaluation According to Ventilation Strategy During Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
Actual Study Start Date :
Aug 2, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Group N

Stopping ventilation during cardiopulmonary bypass

Active Comparator: Group V

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

Outcome Measures

Primary Outcome Measures

  1. postoperative pulmonary ventilation disorders [after ICU transferring (up to 1hour)]

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

Secondary Outcome Measures

  1. incidence of postoperative pulmonary complications [during ICU hospitalization (up to 7 days)]

    the difference in the incidence of postoperative pulmonary complications according to the pulmonary ventilation strategy at the time of cardiopulmonary bypass in minimally invasive cardiac surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Adults over 18 years of age

  2. Patients who underwent one lung ventilation using a bronchial blocker for minimally invasive cardiac surgery

  3. If there is no atelectasis on chest X-ray or chest computed tomography performed before surgery

Exclusion Criteria:
  1. 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

  2. Patients scheduled for sternotomy

  3. If there is a skin disease in the chest that requires EIT measurement

  4. If there is a plan to transfer to the intensive care unit while maintaining the endotracheal tube

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Pusan National University Yangsan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hyung Gon Je, Associate professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT04985513
Other Study ID Numbers:
  • 05-2021-156
First Posted:
Aug 2, 2021
Last Update Posted:
Aug 11, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 11, 2021