Heart DiseasesNCT02767687
Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery
A study testing Noninvasive ventilation in people with Heart Diseases and Coronary Artery Disease, run by Federal University of São Paulo.
Trial summary
This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Coronary Artery Disease
- What is being tested?
- Noninvasive ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of central venous catheter
- Invasive arterial pressure catheter
- Invasive mechanical ventilation
Who cannot join
- Chronic obstructive pulmonary disease
- Morbid obesity
- Hemodynamic instability
- Spontaneous breathing
- Need of invasive mechanical ventilation for more than 24 hours
- Intolerance to noninvasive mechanical ventilation
- Extubation failure
About this study
This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.
Read the detailed description
Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter.
Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear.
This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.
- Conditions
- Heart Diseases, Coronary Artery Disease
- Being tested
- Noninvasive ventilation
- Keywords
- Postoperative Care, Postoperative Period, Heart Surgery
- Medical subject headings
- Heart Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilationOther
Also called NIV
Twenty minutes after extubation all subjects will receive noninvasive ventilation delivered through a facial mask with an ICU ventilator with NIV option for 60 minutes. NIV associates pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O).
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive ventilation (NIV) | Experimental | Noninvasive mechanical ventilation is a resource used to treat respiratory failure or to reestablish respiratory comfort and function. It is commonly used in the ICU with a regular mechanical ventilator and is offered using an interface that connects the machine to the patient. The interface used for adults and in this study, was a silicon facial mask that covers the nose and mouth of the patient, allowing him or her to open the eyes. Receives: Other: Noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of central venous oxygen saturation to determine tissue perfusion
All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
Measured: Through study completion, an average of 1 year
Evaluation of arterial lactate to determine tissue perfusion
All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Respiratory complications during hospitalization
Respiratory events as pleural effusion and atelectasis will be evaluated by a professional blind to the protocol of study and will be recorded.
Measured: Through study completion, an average of 1 year
Hemodinamycs complications during hospitalization
Hemodinamycs events as arrhythmia, hypotension and cardiac arrest will be evaluated by a professional blind to the protocol of study and will be recorded.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
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 Heart DiseasesStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha de Oliveira Marcondi, Federal University of São Paulo
- Investigators
- Solange Guizilini, PhD, Study director, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767687
- Sponsor's protocol ID
- 1.156.460
- Status last verified
- May 2016
- First submitted
- 28 Mar 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No participant data will be made available, however every subject was provided the investigator's e-mail address as well a phone number and was encouraged to call or send an e-mail in case of doubt or to receive information regarding the research.
Publications
Marcondi NO, Rocco IS, Bolzan DW, Pauletti HO, Begot I, Anjos NR, Moreira RSL, Nasrala ML, Arena R, Gomes WJ, Guizilini S. Noninvasive Ventilation After Coronary Artery Bypass Grafting in Subjects With Left-Ventricular Dysfunction. Respir Care. 2018 Jul;63(7):879-885. doi: 10.4187/respcare.05851. Epub 2018 Jun 12.
PubMed 29895702
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Non Invasive Mechanical Ventilation on Tissue Perfusion in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02767687
- Acronym / sponsor ID
- 1.156.460
- Conditions
- Heart Diseases, Coronary Artery Disease
- Keywords
- Postoperative Care, Postoperative Period, Heart Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 May 2016 (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.
This study evaluates whether noninvasive ventilation with continuous positive airway pressure affects tissue perfusion in patients after cardiac surgery.
Detailed description
Patients submitted to open chest cardiac surgery will be enrolled after ICU admission. These patients will be submitted to noninvasive mechanical ventilation with continuous positive airway pressure right after extubation and tissue perfusion markers (central venous oxygen saturation (SVcO2) and lactate) will be obtained via central venous catheter.
Noninvasive mechanical ventilation is a common resource in the ICU to reduce extubation failures and to improve clinical outcomes, whether it can influence tissue perfusion remains unclear.
This study evaluates whether noninvasive ventilation affects tissue perfusion and whether tissue perfusion markers in the ICU are correlated with better clinical results for patients after heart surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noninvasive ventilation (NIV) | Experimental | Other: Noninvasive ventilationNoninvasive mechanical ventilation is a resource used to treat respiratory failure or to reestablish respiratory comfort and function. It is commonly used in the ICU with a regular mechanical ventilator and is offered using an interface that connects the machine to the patient. The interface used for adults and in this study, was a silicon facial mask that covers the nose and mouth of the patient, allowing him or her to open the eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of central venous catheter
- Invasive arterial pressure catheter
- Invasive mechanical ventilation
Key exclusion criteria (7 listed)
- Chronic obstructive pulmonary disease
- Morbid obesity
- Hemodynamic instability
- Spontaneous breathing
- Need of invasive mechanical ventilation for more than 24 hours
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 |
|---|---|---|
| Noninvasive ventilationAlso: NIVTwenty minutes after extubation all subjects will receive noninvasive ventilation delivered through a facial mask with an ICU ventilator with NIV option for 60 minutes. NIV associates pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O). | Other | Noninvasive ventilation (NIV) |
Primary outcome
Evaluation of central venous oxygen saturation to determine tissue perfusion
Time frame: Through study completion, an average of 1 year
All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the central venous catheter at different times to evaluate central venous oxygen saturation. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
Evaluation of arterial lactate to determine tissue perfusion
Time frame: Through study completion, an average of 1 year
All patients will be admitted in ICU after surgery and will be submitted to four blood collections from the arterial invasive catheter at different times to evaluate arterial lactate. Time 1: at ICU admission in mechanical ventilation. Time 2 : twenty minutes after extubation, before the noninvasive ventilation protocol, while breathing spontaneously with a 40% oxygen mask. Time 3: At 60 minutes of noninvasive ventilation protocol. Time 4: twenty minutes after noninvasive ventilation protocol complete while breathing spontaneously with a 40% oxygen mask. The results will be compared between then to assess if there are changes under influence of non invasive ventilation.
2 secondary outcomes
Respiratory complications during hospitalization
Time frame: Through study completion, an average of 1 year
Hemodinamycs complications during hospitalization
Time frame: Through study completion, an average of 1 year
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 10 May 2016.
- Derived from this study: PubMed 29895702Marcondi NO, Rocco IS, Bolzan DW, Pauletti HO, Begot I, Anjos NR, Moreira RSL, Nasrala ML, Arena R, Gomes WJ, Guizilini S. Noninvasive Ventilation After Coronary Artery Bypass Grafting in Subjects With Left-Ventricular Dysfunction. Respir Care. 2018 Jul;63(7):879-885. doi: 10.4187/respcare.05851. Epub 2018 Jun 12.
- Individual participant dataSharing planned: No. No participant data will be made available, however every subject was provided the investigator's e-mail address as well a phone number and was encouraged to call or send an e-mail in case of doubt or to receive information regarding the research.
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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.
Solange Guizilini, PhD study director
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation in people with Heart Diseases and Coronary Artery Disease, run by Federal University of São Paulo.
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 3 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: finished, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of central venous oxygen saturation to determine tissue perfusion (time frame: Through study completion, an average of 1 year). 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 NCT02767687, 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 10 May 2016.