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Clinical Trials/NCT04813250
NCT04813250
Completed
N/A

The Effects of Ventilatory Strategies on Pulmonary Function After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography in Patients Undergoing Cardiac Surgery

National Defense Medical Center, Taiwan1 site in 1 country50 target enrollmentAugust 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Elective Cardiac Surgical Patients
Sponsor
National Defense Medical Center, Taiwan
Enrollment
50
Locations
1
Primary Endpoint
The correlation between Different ventilation mode and the relevant value of EIT
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Pulmonary complications after cardiac surgeries are common. It is one of the most crucial concerns of cardiac surgeons and anesthesiologists. These adverse events may vary from a mild respiratory dysfunction to acute respiratory distress syndrome (ARDS). One of the most public reasons of these complications is atelectasis that would result in hypoxia and pneumonia. Any of these adverse events rises the prevalence of morbidity and mortality. The chief inducing causes for atelectasis are CPB and dropped blood perfusion and ventilation of the lungs. The ventilation arrest is related with a high frequency of retained bronchial sections, local atelectasis, decrease in arterial O2 concentrations as a effect of surge in arteriovenous shunt, declined lung compliance, pulmonary edema and hence increased risk of nosocomial infections.

Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, real time bedside imaging modality, which provide the assessment of regional gas volume and lung ventilation. EIT has been experienced in quite a lot of animal and clinical applications including optimization of mechanical ventilator strategies and recognition of respiratory adverse events. Besides, EIT has been used to recognize ideal PEEP by detection of homogenous ventilation in non-dependent and dependent lung regions. Homogeneous ventilation is key for inhibition of ventilator-induced lung injury.

Detailed Description

The aim of this study is to use four different ventilatory strategies 【Group R : IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) ; Group RP, Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O ;Group RI : Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1) ;Group RPI: Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1)】 to compare the beneficial in decreasing the incidence of post-operative pulmonary dysfunction after cardiac surgery including of the data of EIT, GAS , Lactate , PFR:PaO2/FiO2 ratio , cardiac index (CI) , BMI..etc . EIT were measured at two perioperative timepoints 1. after intubation at the onset of anesthesia with mechanical ventilation with 7ml/ kg (Predicted body weight) 2. at the end of surgery.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
July 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Defense Medical Center, Taiwan
Responsible Party
Principal Investigator
Principal Investigator

Yung-Chi Hsu

Attending Physician of Department of Anesthesiology

Tri-Service General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age between 20-80 year-old
  • Adult patients receiving elective cardiac surgery with hypothermic CPB

Exclusion Criteria

  • Patients were excluded if they had complicating comorbidities, such as chronic hepatic or renal insufficiency, acute cardiopulmonary failure requiring mechanical ventilation, intra-aortic balloon pump, or extracorporeal membrane oxygenation

Outcomes

Primary Outcomes

The correlation between Different ventilation mode and the relevant value of EIT

Time Frame: since weaning cardiopulmonary bypass (CPB) to the end of surgery

Compare the correlation between Different ventilation mode and the relevant value of EIT in the population of open heart surgery patient

The demographic characteristics and relevant value of EIT

Time Frame: since weaning cardiopulmonary bypass (CPB) to the end of surgery

Campare the demographic characteristics and relevant value of EIT in the population of open heart surgery patient

Secondary Outcomes

  • If the different ventilation mode setting can improve clinical outcome(since weaning cardiopulmonary bypass (CPB) to the end of surgery)
  • The correlation between heart function & oxygenation and different ventilation mode(since weaning cardiopulmonary bypass (CPB) to the end of surgery)

Study Sites (1)

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