Thoracic SurgeryNCT03141216
Patient-ventilator Asynchrony in Conventional Ventilation Modes During Short-term Mechanical Ventilation After Cardiac Surgery
A study testing VCV+PSV and PCV+PSV in people with Thoracic Surgery, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate postoperative period on the variables resulting from regional and global pulmonary electrical impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV mode by mechanical ventilator. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- VCV+PSV and PCV+PSV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Mar 2017to 31 Dec 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IMC 18.5-29.9 kg/m²
- Two thoracic tubes (one mediastinal and one left-sided pleural)
- under mechanical ventilation after surgery
- submitted to intraoperative extracorporeal circulation
Who cannot join
- Over 2h of cardiopulmonary bypass
- Over 12h of post-operative mechanical ventilation
- Post-operative bleeding above 500 ml in the first hour or above 300 ml in the first two hours
- History of special conditions (neuromuscular and chronic pulmonary disease, thoracic deformity, abdominal distension).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Real Português de Beneficência em Pernambuco
Recife, Pernambuco, 52010-040
About this study
Official title: Effects of Mechanical Ventilation on Controlled Volume, Controlled Pressure and Pressure Support in the Immediate Postoperative Period of Cardiac Surgery on Pulmonary Electrical Impedance and Patient-ventilator Asynchrony: a Parallel Clinical Trial
This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate postoperative period on the variables resulting from regional and global pulmonary electrical impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV mode by mechanical ventilator. Half of the participants will receive VCV followed by PSV for weaning, while the other half will receive PCV followed by PSV for weaning.
Read the detailed description
In the immediate postoperative period of cardiac surgery, patients are found under mechanical ventilatory support. Commonly, they are ventilated in controlled and assisted-controlled volume (VCV) or pressure (PCV) modes, with weaning at pressure support (PSV).
Systematic reviews indicate that there is no difference between the VCV and PCV ventilatory modes for some clinical outcomes or that the existing evidence is insufficient. The distribution of regional ventilation and diaphragmatic mobility can be measured from the use of electrical impedance tomography (EIT) and diaphragmatic ultrasonography (US) to clarify the physiological changes and / or mechanisms of adaptation of the organism submitted to controlled modes cycled at volume or at pressure and spontaneously flow cycled mode.
Besides EIT and US measures, gasometric, hemodynamic and respiratory data will also be recorded. The statistical analysis will be considered α≤0.05 for a statistically significant difference.
- Conditions
- Thoracic Surgery
- Being tested
- VCV+PSV, PCV+PSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCV+PSVDevice
Also called volume controlled ventilation mode, pressure support ventilation mode
invasive mechanical mechanical modes by volume cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.
PCV+PSVDevice
Also called pressure controlled ventilation mode, pressure support mode
invasive mechanical mechanical modes by pressure cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.
| Study group | Role | What they receive |
|---|---|---|
| VCV+PSV | Experimental | volume controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery. Receives: Device: VCV+PSV |
| PCV+PSV | Experimental | pressure controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery. Receives: Device: PCV+PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrical impedance measures
impedance variation data recorded by a tomograph.
Measured: 5 minutes of recording at each step of mechanical ventilation progression before extubation.
Secondary outcomes (2)
arterial gas blood analysis data
measures of pH, PaCO2 (mmHg), PaO2 (mmHg), PaO2/FiO2
Measured: up to 12h, following routine care while patients are mechanically ventilated
patient-ventilator synchrony
events of discomfort between patient and ventilator: ineffective efforts and auto-triggering. Expressed in present or ausent.
Measured: 5 minutes of recording at each step of mechanical ventilation progression before extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start9 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group study is a simple and commonly used clinical design which compares two treatments. Usually a test therapy is compared with a standard therapy. The allocation of subjects to groups is usually achieved by randomisation. The groups are typically named the treatment group and the control group. Parallel group designs do not require the same number of subjects in each group, although often similar numbers are observed. The design is commonly used in randomised controlled trials. Statistical analysis often boils down to a simple t-test of the between group difference in the outcome, which is usually a mean or a proportion.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Collaborators
- Real Hospital Português de Beneficência em Pernambuco
- Responsible party
- Principal investigator, Wagner Souza Leite, Universidade Federal de Pernambuco
- Investigators
- WAGNER S LEITE, Principal investigator, Universidade Federal de PernambucoShirley Lima Campos, Study chair, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141216
- Sponsor's protocol ID
- 03021991
- Status last verified
- Sep 2019
- First submitted
- 21 Feb 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: to be shared are: data provided by electrical impedance tomograph, by ultrasound and general clinical one (such as blood pressure, oxygen supplementary concentration, heart rate, respiratory rate, mechanical ventilation duration, surgery duration). These data will be available for sharing after the end of the study and it will be obtained by a copy in a USB flash drive.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mechanical Ventilation on Controlled Volume, Controlled Pressure and Pressure Support in the Immediate Postoperative Period of Cardiac Surgery on Pulmonary Electrical Impedance and Patient-ventilator Asynchrony: a Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT03141216
- Acronym / sponsor ID
- 03021991
- Conditions
- Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Collaborators
- Real Hospital Português de Beneficência em Pernambuco
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 5 May 2017 (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.
This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate postoperative period on the variables resulting from regional and global pulmonary electrical impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV mode by mechanical ventilator. Half of the participants will receive VCV followed by PSV for weaning, while the other half will receive PCV followed by PSV for weaning.
Detailed description
In the immediate postoperative period of cardiac surgery, patients are found under mechanical ventilatory support. Commonly, they are ventilated in controlled and assisted-controlled volume (VCV) or pressure (PCV) modes, with weaning at pressure support (PSV).
Systematic reviews indicate that there is no difference between the VCV and PCV ventilatory modes for some clinical outcomes or that the existing evidence is insufficient. The distribution of regional ventilation and diaphragmatic mobility can be measured from the use of electrical impedance tomography (EIT) and diaphragmatic ultrasonography (US) to clarify the physiological changes and / or mechanisms of adaptation of the organism submitted to controlled modes cycled at volume or at pressure and spontaneously flow cycled mode.
Besides EIT and US measures, gasometric, hemodynamic and respiratory data will also be recorded. The statistical analysis will be considered α≤0.05 for a statistically significant difference.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel group study is a simple and commonly used clinical design which compares two treatments. Usually a test therapy is compared with a standard therapy. The allocation of subjects to groups is usually achieved by randomisation. The groups are typically named the treatment group and the control group. Parallel group designs do not require the same number of subjects in each group, although often similar numbers are observed. The design is commonly used in randomised controlled trials. Statistical analysis often boils down to a simple t-test of the between group difference in the outcome, which is usually a mean or a proportion.
| Arm | Type | Receives |
|---|---|---|
| VCV+PSV | Experimental | Device: VCV+PSVvolume controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery. |
| PCV+PSV | Experimental | Device: PCV+PSVpressure controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- IMC 18.5-29.9 kg/m²
- Two thoracic tubes (one mediastinal and one left-sided pleural)
- under mechanical ventilation after surgery
- submitted to intraoperative extracorporeal circulation
Key exclusion criteria (4 listed)
- Over 2h of cardiopulmonary bypass
- Over 12h of post-operative mechanical ventilation
- Post-operative bleeding above 500 ml in the first hour or above 300 ml in the first two hours
- History of special conditions (neuromuscular and chronic pulmonary disease, thoracic deformity, abdominal distension).
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 |
|---|---|---|
| VCV+PSVAlso: volume controlled ventilation mode, pressure support ventilation modeinvasive mechanical mechanical modes by volume cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission. | Device | VCV+PSV |
| PCV+PSVAlso: pressure controlled ventilation mode, pressure support modeinvasive mechanical mechanical modes by pressure cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission. | Device | PCV+PSV |
Primary outcome
electrical impedance measures
Time frame: 5 minutes of recording at each step of mechanical ventilation progression before extubation.
impedance variation data recorded by a tomograph.
2 secondary outcomes
arterial gas blood analysis data
Time frame: up to 12h, following routine care while patients are mechanically ventilated
patient-ventilator synchrony
Time frame: 5 minutes of recording at each step of mechanical ventilation progression before extubation
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 26 Sep 2019.
- Right ventricular function during one-lung ventilation: effects of pressure-controlled and volume-controlled ventilationLink provided by the sponsor.
- Effect of a protective-ventilation strategy on mortality in the acute respiratory distress syndrome.Link provided by the sponsor.
- Tidal ventilation distribution during pressure-controlled ventilation and pressure support ventilation in post-cardiac surgery patients.Link provided by the sponsor.
- Monitoring perioperative changes in distribution of pulmonary ventilation by functional electrical impedance tomography.Link provided by the sponsor.
- Refining ventilatory treatment for acute lung injury and acute respiratory distress syndrome.Link provided by the sponsor.
- Bedside waveforms interpretation as a tool to identify patient-ventilator asynchronies.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. to be shared are: data provided by electrical impedance tomograph, by ultrasound and general clinical one (such as blood pressure, oxygen supplementary concentration, heart rate, respiratory rate, mechanical ventilation duration, surgery duration). These data will be available for sharing after the end of the study and it will be obtained by a copy in a USB flash drive.
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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.
WAGNER S LEITE principal investigator
Universidade Federal de Pernambuco
Shirley Lima Campos study chair
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCV+PSV and PCV+PSV in people with Thoracic Surgery, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 4 inclusion and 4 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 26 Sep 2019. 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 Brazil. 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. 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?
electrical impedance measures (time frame: 5 minutes of recording at each step of mechanical ventilation progression before extubation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2019; AzTrials last refreshed its copy on 30 Oct 2026.