Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography

Elective Cardiac Surgical Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04813250
• Other study ID #: Ventilatory with EIT post CPB
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2021
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Elective Cardiac Surgical Patients

Intervention

Other:
• ventilation 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

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Tri-Service General Hospital	Taipei City	Neihu Dist

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Spinelli E, Mauri T, Fogagnolo A, Scaramuzzo G, Rundo A, Grieco DL, Grasselli G, Volta CA, Spadaro S. Electrical impedance tomography in perioperative medicine: careful respiratory monitoring for tailored interventions. BMC Anesthesiol. 2019 Aug 7;19(1):140. doi: 10.1186/s12871-019-0814-7. Review. Erratum in: BMC Anesthesiol. 2019 Sep 4;19(1):172. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation between Different ventilation mode and the relevant value of EIT	Compare the correlation between Different ventilation mode and the relevant value of EIT in the population of open heart surgery patient	since weaning cardiopulmonary bypass (CPB) to the end of surgery
Primary	The demographic characteristics and relevant value of EIT	Campare the demographic characteristics and relevant value of EIT in the population of open heart surgery patient	since weaning cardiopulmonary bypass (CPB) to the end of surgery
Secondary	If the different ventilation mode setting can improve clinical outcome	Identify the different ventilation mode setting in open heart surgery patient if can improve clinical care benifit.	since weaning cardiopulmonary bypass (CPB) to the end of surgery
Secondary	The correlation between heart function & oxygenation and different ventilation mode	Survey the correlation between heart function & oxygenation and different ventilation mode	since weaning cardiopulmonary bypass (CPB) to the end of surgery