Elective Cardiac Surgical PatientsNCT04813250
Ventilatory Strategies After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography
A study testing ventilation mode setting in people with Elective Cardiac Surgical Patients, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Elective Cardiac Surgical Patients
- What is being tested?
- ventilation mode setting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20-80 year-old
- Adult patients receiving elective cardiac surgery with hypothermic CPB
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Anesthesiology, Tri-Service General Hospital
Taipei, Neihu Dist, 11490
About this study
Official title: The Effects of Ventilatory Strategies on Pulmonary Function After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography in Patients Undergoing Cardiac Surgery
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.
Read the 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
- Being tested
- ventilation mode setting
- Keywords
- Ventilatory strategies, Electrical Impedance Tomography, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilation mode settingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group R | Sham comparator | IMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) Receives: Other: ventilation mode setting |
| Group RP | Experimental | Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O Receives: Other: ventilation mode setting |
| Group RI | Experimental | Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1) Receives: Other: ventilation mode setting |
| Group RPI | Experimental | Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1) Receives: Other: ventilation mode setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: since weaning cardiopulmonary bypass (CPB) to the end of surgery
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
Measured: since weaning cardiopulmonary bypass (CPB) to the end of surgery
Secondary outcomes (2)
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.
Measured: since weaning cardiopulmonary bypass (CPB) to the end of surgery
The correlation between heart function & oxygenation and different ventilation mode
Survey the correlation between heart function \& oxygenation and different ventilation mode
Measured: since weaning cardiopulmonary bypass (CPB) to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Aug 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Cardiac Surgical PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yung-Chi Hsu, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813250
- Sponsor's protocol ID
- Ventilatory with EIT post CPB
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 31390977
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ventilatory Strategies on Pulmonary Function After Cardiopulmonary Bypass Evaluated by Electrical Impedance Tomography in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04813250
- Acronym / sponsor ID
- Ventilatory with EIT post CPB
- Conditions
- Elective Cardiac Surgical Patients
- Keywords
- Ventilatory strategies, Electrical Impedance Tomography, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Group R | Sham comparator | Other: ventilation mode settingIMV(intermittent mandatory ventilation) Regular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) |
| Group RP | Experimental | Other: ventilation mode settingRegular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O |
| Group RI | Experimental | Other: ventilation mode settingRegular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + Reverse IE ratio ventilation( I:E=1:1) |
| Group RPI | Experimental | Other: ventilation mode settingRegular Ventilation with Tidal volume with 7ml/ kg (Predicted body weight) + PEEP : 6 cm H2O + Reverse IE ratio ventilation( I:E=1:1) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 20-80 year-old
- Adult patients receiving elective cardiac surgery with hypothermic CPB
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilation mode settingVentilation 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 | Other | Group R, Group RI, Group RP, Group RPI |
Primary outcome
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
2 secondary outcomes
If the different ventilation mode setting can improve clinical outcome
Time frame: since weaning cardiopulmonary bypass (CPB) to the end of surgery
The correlation between heart function & oxygenation and different ventilation mode
Time frame: since weaning cardiopulmonary bypass (CPB) to the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 31390977Spinelli 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilation mode setting in people with Elective Cardiac Surgical Patients, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between Different ventilation mode and the relevant value of EIT (time frame: since weaning cardiopulmonary bypass (CPB) to the end of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.