Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography

Not Applicable

Completed

• Conditions: Elective Cardiac Surgical Patients
• Interventions: Other: ventilation mode setting

• Registration Number: NCT04813250
• Lead Sponsor: National Defense Medical Center, Taiwan

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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2021-03
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-24
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group RP	ventilation mode setting	Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O
Group RPI	ventilation mode setting	Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1)
Group RI	ventilation mode setting	Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1)
Group R	ventilation mode setting	IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight)

Primary Outcome Measures

Name	Time	Method
The correlation between Different ventilation mode and the relevant value of EIT	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	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 Outcome Measures

Name	Time	Method
If the different ventilation mode setting can improve clinical outcome	since weaning cardiopulmonary bypass (CPB) to the end of surgery	Identify the different ventilation mode setting in open heart surgery patient if can improve clinical care benifit.
The correlation between heart function & oxygenation and different ventilation mode	since weaning cardiopulmonary bypass (CPB) to the end of surgery	Survey the correlation between heart function \& oxygenation and different ventilation mode

Trial Locations

Locations (1)

Department of Anesthesiology, Tri-Service General Hospital; 🇨🇳 Taipei City, Neihu Dist, Taiwan