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Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04813250
Enrollment
50
Registered
2021-03-24
Start date
2018-08-01
Completion date
2019-07-31
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elective Cardiac Surgical Patients

Keywords

Ventilatory strategies, Electrical Impedance Tomography, cardiac surgery

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.

Interventions

OTHERventilation mode setting

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

Sponsors

National Defense Medical Center, Taiwan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

De-identify the data before analyse the data by outcome saaessor

Intervention model description

Ventilation strategies with 4 different ventilation 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

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The correlation between Different ventilation mode and the relevant value of EITsince weaning cardiopulmonary bypass (CPB) to the end of surgeryCompare 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 EITsince weaning cardiopulmonary bypass (CPB) to the end of surgeryCampare the demographic characteristics and relevant value of EIT in the population of open heart surgery patient

Secondary

MeasureTime frameDescription
If the different ventilation mode setting can improve clinical outcomesince weaning cardiopulmonary bypass (CPB) to the end of surgeryIdentify 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 modesince weaning cardiopulmonary bypass (CPB) to the end of surgerySurvey the correlation between heart function & oxygenation and different ventilation mode

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026