Post Operative Cardiac SurgeryNCT02056977
PEEP Levels Selected by PEEP Titration and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure
A study testing Titration in people with Post Operative Cardiac Surgery and ARDS, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to: Compare PEEP level selected by individualized PEEP titration by electrical impedance tomography and PEEP level routinely used in post-operative cardiac patients with Hypoxemic Respiratory Failure; Evaluate the agreement between the results of a rapid titration (total procedure duration… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Cardiac Surgery, ARDS, Hypoxemic Respiratory Failure
- What is being tested?
- Titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Jan 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
- Acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2) no >200 mmHg and bilateral pulmonary infiltrates on XRay consistent with edema, and no clinical evidence of left atrial hypertension (pulmonary capillary wedge pressure <18 mmHg, when available).
- Age > 18 and < 70 years old
- Absence previous pulmonary disease
- Left ventricular ejection fraction > 35%
- Absence of previous cardiac surgery and / or lung disease;
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- Not requiring adjusted volume expansion (pulse pressure delta <13% or legs raising test without hemodynamic changes in cardiac index or mean arterial pressure).
- Body mass index < 40 kg/m2
- Written inform consent
Who cannot join
- MAP < 70 mmHg
- Noradrenaline > 1 micrograms/Kg/min
- Acute arrhythmias
- Blooding associated to hemodynamic instability
- Need of re-surgery and/or mechanical circulatory assistance
- Suspicion of neurological alteration
- Chest tube with persistent air leak
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
USP Instituto do Coração
São Paulo, 05.403-010
Marcelo BP Amato, 30667361, marcelo.amato@limpneumo.fm.usp.br
Maria AM Nakamura, 30667361, mamiyukinakamura@gmail.com
About this study
Official title: Comparison Between PEEP Levels Selected by Individualized PEEP Titration - Rapid Titration by EIT - and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure
The purpose of this study is to:
- Compare PEEP level selected by individualized PEEP titration by electrical impedance tomography and PEEP level routinely used in post-operative cardiac patients with Hypoxemic Respiratory Failure;
- Evaluate the agreement between the results of a rapid titration (total procedure duration = 5 min) versus an already validated slow titration (total procedure duration = 40 min) of the same patient, sequentially. Specifically, degree of collapse and degree of distention in each PEEP level, estimated by EIT;
- Compare hemodynamics during the two maneuvers of PEEP titration;
- Evaluate the efficacy of the selected PEEP (minimum PEEP preventing lung collapse less than 5%) to maintain stable levels of the following variables: arterial oxygenation, respiratory system compliance, and degree of collapse by EIT;
- Compare these results (evolution of the three variables, along 4 hours) with the control strategy (default strategy currently used in the institution) group.
Read the detailed description
The acute respiratory distress syndrome (ARDS) increases the morbidity and mortality of patients admitted to the intensive care unit (ICU). In the postoperative period of cardiac surgery, the use of intraoperative extracorporeal circulation is one of the factors triggering the syndrome, its incidence increasing.
Potentially, a protective ventilatory strategy with optimal positive end expiratory pressure (PEEP) could improve the prognosis of those patients with ARDS.
An already validated maneuver to titrate the ideal PEEP to these patients has a longer duration, about 40 minutes. The lung Electrical impedance tomography (EIT) monitors respiratory system mechanics and intrathoracic lung volume changes and provides information about regional behavior and recruitability of lung tissue and thereby allows shortening titration maneuver, reducing its hemodynamic effects.
Patients in the postoperative period of cardiac surgery with a diagnosis of Hypoxemic Respiratory Failure (PaO2/FiO2 < 250 mmHg, calculated at FiO2 60%, and the presence of bilateral infiltrates on chest radiography), admitted to the surgical ICU from Heart Institute, University of São Paulo.
Recruitment maneuver and PEEP titration maneuver will be monitored by EIT.
All patients will be followed and monitored for 4 hours, with measures of the evolution of alveolar collapse . Hemodynamic and oxygenation data will also be recorded .
- Being tested
- Titration, control
- Keywords
- Acute Respiratory Distress Syndrome, Cardiac Surgical Procedure, Mechanical Ventilation, Postoperative Complications, Positive End-Expiratory Pressure, Lung Collapse, Respiratory Failure, Electrical Impedance Tomography
- Medical subject headings
- Respiratory Insufficiency, Respiratory Distress Syndrome, Postoperative Complications, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TitrationOther
Also called Individualized PEEP
Individualized PEEP according to PEEP titration monitored by EIT
controlOther
Also called Control PEEP
PEEP selected according to a PaO2/FIO2 table as in the routines of the institution
| Study group | Role | What they receive |
|---|---|---|
| Titration | Experimental | Individualized PEEP titration by EIT Receives: Other: Titration |
| Control | Active comparator | PEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio) Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the agreement between the ideal PEEP determined by rapid titration versus and the ideal PEEP determined by the slow PEEP titration maneuver.
Evaluate the agreement between the ideal PEEP determined by the rapid PEEP titration maneuver versus the ideal PEEP determined by the slow PEEP titration maneuver. The degree of collapse and overdistention at each PEEP level, as estimated by EIT, will be also compared during both procedures. Ideal PEEP is the minimum PEEP capable of keeping collapse at < 5%.
Measured: 2 hours
Secondary outcomes (1)
Stability of the selected PEEP according to the rapid titration in arterial oxygenation (SpO2, in %), respiratory system compliance (in cmH2O), and degree of collapse by EIT (in %)
Evaluate the stability of the selected PEEP (according to the rapid titration), by analyzing the maintenance of three variables over a four hour period: arterial oxygenation, respiratory system compliance, and degree of collapse by EIT
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
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 Post Operative Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Responsible party
- Sponsor
- Investigators
- Marcelo BP Amato, Principal investigator, Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056977
- Sponsor's protocol ID
- 513.205
- Status last verified
- Nov 2017
- First submitted
- 5 Feb 2014
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Costa EL, Amato M. Hemodynamic and respiratory changes during lung recruitment and descending optimal positive end-expiratory pressure titration with acute respiratory distress syndrome. Crit Care Med. 2007 Aug;35(8):1998-9; author reply 1999. doi: 10.1097/01.ccm.0000277060.87425.6b. No abstract available.
PubMed 17667256
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between PEEP Levels Selected by Individualized PEEP Titration - Rapid Titration by EIT - and PEEP Levels Routinely Used in Post-operative Cardiac Patients With Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT02056977
- Acronym / sponsor ID
- 513.205
- Keywords
- Acute Respiratory Distress Syndrome, Cardiac Surgical Procedure, Mechanical Ventilation, Postoperative Complications, Positive End-Expiratory Pressure, Lung Collapse, Respiratory Failure, Electrical Impedance Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Financiadora de Estudos e Projetos
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 6 Feb 2014 (estimated)
- 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.
The purpose of this study is to:
- Compare PEEP level selected by individualized PEEP titration by electrical impedance tomography and PEEP level routinely used in post-operative cardiac patients with Hypoxemic Respiratory Failure;
- Evaluate the agreement between the results of a rapid titration (total procedure duration = 5 min) versus an already validated slow titration (total procedure duration = 40 min) of the same patient, sequentially. Specifically, degree of collapse and degree of distention in each PEEP level, estimated by EIT;
- Compare hemodynamics during the two maneuvers of PEEP titration;
- Evaluate the efficacy of the selected PEEP (minimum PEEP preventing lung collapse less than 5%) to maintain stable levels of the following variables: arterial oxygenation, respiratory system compliance, and degree of collapse by EIT;
- Compare these results (evolution of the three variables, along 4 hours) with the control strategy (default strategy currently used in the institution) group.
Detailed description
The acute respiratory distress syndrome (ARDS) increases the morbidity and mortality of patients admitted to the intensive care unit (ICU). In the postoperative period of cardiac surgery, the use of intraoperative extracorporeal circulation is one of the factors triggering the syndrome, its incidence increasing.
Potentially, a protective ventilatory strategy with optimal positive end expiratory pressure (PEEP) could improve the prognosis of those patients with ARDS.
An already validated maneuver to titrate the ideal PEEP to these patients has a longer duration, about 40 minutes. The lung Electrical impedance tomography (EIT) monitors respiratory system mechanics and intrathoracic lung volume changes and provides information about regional behavior and recruitability of lung tissue and thereby allows shortening titration maneuver, reducing its hemodynamic effects.
Patients in the postoperative period of cardiac surgery with a diagnosis of Hypoxemic Respiratory Failure (PaO2/FiO2 < 250 mmHg, calculated at FiO2 60%, and the presence of bilateral infiltrates on chest radiography), admitted to the surgical ICU from Heart Institute, University of São Paulo.
Recruitment maneuver and PEEP titration maneuver will be monitored by EIT.
All patients will be followed and monitored for 4 hours, with measures of the evolution of alveolar collapse . Hemodynamic and oxygenation data will also be recorded .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titration | Experimental | Other: TitrationIndividualized PEEP titration by EIT |
| Control | Active comparator | Other: controlPEEP stablished according to the routines at the institution (PEEP table according to the P/F ratio) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
- Acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2) no >200 mmHg and bilateral pulmonary infiltrates on XRay consistent with edema, and no clinical evidence of left atrial hypertension (pulmonary capillary wedge pressure <18 mmHg, when available).
- Age > 18 and < 70 years old
- Absence previous pulmonary disease
- Left ventricular ejection fraction > 35%
Key exclusion criteria (7 listed)
- MAP < 70 mmHg
- Noradrenaline > 1 micrograms/Kg/min
- Acute arrhythmias
- Blooding associated to hemodynamic instability
- Need of re-surgery and/or mechanical circulatory assistance
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 |
|---|---|---|
| TitrationAlso: Individualized PEEPIndividualized PEEP according to PEEP titration monitored by EIT | Other | Titration |
| controlAlso: Control PEEPPEEP selected according to a PaO2/FIO2 table as in the routines of the institution | Other | Control |
Primary outcome
To test the agreement between the ideal PEEP determined by rapid titration versus and the ideal PEEP determined by the slow PEEP titration maneuver.
Time frame: 2 hours
Evaluate the agreement between the ideal PEEP determined by the rapid PEEP titration maneuver versus the ideal PEEP determined by the slow PEEP titration maneuver. The degree of collapse and overdistention at each PEEP level, as estimated by EIT, will be also compared during both procedures. Ideal PEEP is the minimum PEEP capable of keeping collapse at < 5%.
1 secondary outcome
Stability of the selected PEEP according to the rapid titration in arterial oxygenation (SpO2, in %), respiratory system compliance (in cmH2O), and degree of collapse by EIT (in %)
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
- Background: PubMed 17667256Costa EL, Amato M. Hemodynamic and respiratory changes during lung recruitment and descending optimal positive end-expiratory pressure titration with acute respiratory distress syndrome. Crit Care Med. 2007 Aug;35(8):1998-9; author reply 1999. doi: 10.1097/01.ccm.0000277060.87425.6b. No abstract available.
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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.
Marcelo BP Amato principal investigator
Department of Cardio-Pulmonar, Pulmonary Division, Hospital das Clínicas, University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titration in people with Post Operative Cardiac Surgery and ARDS, run by University of Sao Paulo General Hospital 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 22 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcelo BP Amato (3061-7361, marcelo.amato@limpneumo.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the agreement between the ideal PEEP determined by rapid titration versus and the ideal PEEP determined by the slow PEEP titration maneuver. (time frame: 2 hours). 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 NCT02056977, 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 22 Nov 2017.