Completed

NCT Number: NCT04813250

Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography

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.

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Key information

Conditions

Elective Cardiac Surgical Patients

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology, Tri-Service General Hospital

Taipei, Neihu Dist, 11490, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ventilation mode setting

Other

Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35～45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position

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

Time frame: 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

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

Survey the correlation between heart function & oxygenation and different ventilation mode

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Mar 24, 2021
Registry last updated: Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.