Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography

NCT ID: NCT04813250

Last Updated: 2021-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-07-31

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.

Conditions

Elective Cardiac Surgical Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Group R

IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight)

Group Type: SHAM_COMPARATOR

ventilation mode setting

Intervention Type: 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

Group RP

Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O

Group Type: EXPERIMENTAL

ventilation mode setting

Intervention Type: 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

Group RI

Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1)

Group Type: EXPERIMENTAL

ventilation mode setting

Intervention Type: 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

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)

Group Type: EXPERIMENTAL

ventilation mode setting

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Defense Medical Center, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Yung-Chi Hsu

Attending Physician of Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology, Tri-Service General Hospital

Taipei, Neihu Dist, Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 31390977 (View on PubMed)

Other Identifiers

Ventilatory with EIT post CPB

Identifier Type: -

Identifier Source: org_study_id