Thoracic SurgeryNCT03371628
Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in Post-Operative Cardiac Surgery
A study testing Non invasive ventilation in people with Thoracic Surgery, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and atelectasis. Noninvasive ventilation has been used to prevent and treat such complications. Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation and pulmonary ventilation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Dec 2017to 28 Feb 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Immediate postoperative period of cardiac surgery
- age between 18 and 65 years
- BMI between 18.5 and 30 kg / m2
- Patients still intubated when admitted to the ICU
- without previous history of severe pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, or chronic renal failure, or associated neuromuscular diseases
Who cannot join
- Patients considered to be at risk for extubation failure (hypercapnia, more than failure in the autonomic test, AVM time greater than 72 hours, ineffective cough)
- Cardiopulmonary bypass time more than 150 minutes
- Hemodynamic instability (arrhythmias, cardiogenic shock, severe hypotension with SBP <90mmHg)
- Episodes of abdominal distension, nausea and vomiting
- Hypoxemia (PO2 <50mmHg with FiO2 50%) or hypercapnia (PaCO2> 55mmHg with pH <7.30)
- Patients who are at high surgical risk according to Euroscore II
Trial locations and contacts
1 site in 1 country.
Wagner Leite, specialist contact
Brazil1 site, 1 recruiting
- Recruiting
Alita Paula Lopes de Novaes
Recife, Pernambuco, 50751380
Alita Paula L de Novaes, 81991610199, alitanovaes@gmail.com
About this study
Official title: Use of Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in the Post-Operative Cardiac Surgery: Controlled and Randomized Clinical Trial
NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and atelectasis. Noninvasive ventilation has been used to prevent and treat such complications. Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation and pulmonary ventilation. OBJECTIVE: To compare the effects of non-invasive ventilation with oxygen therapy in cardiac post-operative patients. MATERIALS AND METHODS: It will be a randomized controlled clinical trial where patients will be divided into two groups: a group that will perform NIV for 1 hour and the group that will only use oxygen therapy. They will be evaluated through Electrical Impedance Tomography and arterial gasometry analysis just before extubation, soon after extubation, during the intervention and after the intervention for a period of 2 hours after extubation. EXPECTED RESULTS: It is expected that the NIV group will present higher pulmonary ventilation and aeration and better gas exchange than the oxygen therapy group, and that the time of therapeutic effect will be higher in the NIV group.
Read the detailed description
The proposal basically consists of Validation of the hypothesis: The use of Non-invasive Ventilation in patients in the postoperative cardiac surgery results in greater ventilation, greater aeration, and improved gas exchange when compared to the oxygen therapy group.
The use of noninvasive ventilation in the postoperative cardiac surgery has been widely used in clinical practice, but the evidence of the benefits of this technique in this population in relation to some criteria have not yet been elucidated in the scientific literature, such as the effect of NIV in ventilation and pulmonary ventilation, and how long does this effect last.
- Conditions
- Thoracic Surgery
- Being tested
- Non invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationDevice
Non invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway.
| Study group | Role | What they receive |
|---|---|---|
| Group VNI 1h | Experimental | Intervention: Non invasive ventilation, applied for 1 hour Receives: Device: Non invasive ventilation |
| Group O2 | No intervention | Oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in electrical impedance measures
impedance variation data recorded by impedance electrical tomography
Measured: data recorded 5 minutes before extubation, 5 minutes after extubation, at the first 5 minutes of therapy, 25 to 30 minutes after beginning of therapy, 55 to 60 minutes after beginning of therapy, and 1,5 hour and 2 hours after beginning of therapy
Secondary outcomes (1)
change in Blood gases analysis - PaO2 (mmHg), PaCO2 (mmHg), PaO2/FiO2
Collected by a Laboratory professional
Measured: recorded 5 minutes before extubation and 1 hour after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start6 Dec 2017
- Primary completion12 Dec 2017
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- 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
- Treatment
- 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
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alita Paula Lopes de Novaes, Universidade Federal de Pernambuco
- Investigators
- Daniella C Brandão, PhD, Study director, UFPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371628
- Sponsor's protocol ID
- Tomografia de Impedância
- Status last verified
- Dec 2017
- First submitted
- 20 Nov 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datas relative to the results of the use of electrical impedance tomography, besides blood gases and vital signs.
Publications
Jaber S, Chanques G, Jung B. Postoperative noninvasive ventilation. Anesthesiology. 2010 Feb;112(2):453-61. doi: 10.1097/ALN.0b013e3181c5e5f2. No abstract available.
PubMed 20068454Rahmanian PB, Kroner A, Langebartels G, Ozel O, Wippermann J, Wahlers T. Impact of major non-cardiac complications on outcome following cardiac surgery procedures: logistic regression analysis in a very recent patient cohort. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):319-26; discussion 326-7. doi: 10.1093/icvts/ivt149. Epub 2013 May 10.
PubMed 23667066Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.
PubMed 19017864Diodato M, Chedrawy EG. Coronary artery bypass graft surgery: the past, present, and future of myocardial revascularisation. Surg Res Pract. 2014;2014:726158. doi: 10.1155/2014/726158. Epub 2014 Jan 2.
PubMed 25374960Niclauss L. Techniques and standards in intraoperative graft verification by transit time flow measurement after coronary artery bypass graft surgery: a critical review. Eur J Cardiothorac Surg. 2017 Jan;51(1):26-33. doi: 10.1093/ejcts/ezw203. Epub 2016 Jun 13.
PubMed 27298393Yazdannik A, Bollbanabad HM, Mirmohammadsadeghi M, Khalifezade A. The effect of incentive spirometry on arterial blood gases after coronary artery bypass surgery (CABG). Iran J Nurs Midwifery Res. 2016 Jan-Feb;21(1):89-92. doi: 10.4103/1735-9066.174761.
PubMed 26985228Al Jaaly E, Fiorentino F, Reeves BC, Ind PW, Angelini GD, Kemp S, Shiner RJ. Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):912-8. doi: 10.1016/j.jtcvs.2013.03.014. Epub 2013 Apr 11.
PubMed 23582830Kotani T, Tanabe H, Yusa H, Saito S, Yamazaki K, Ozaki M. Electrical impedance tomography-guided prone positioning in a patient with acute cor pulmonale associated with severe acute respiratory distress syndrome. J Anesth. 2016 Feb;30(1):161-5. doi: 10.1007/s00540-015-2084-y. Epub 2015 Oct 7.
PubMed 26446805Vogt B, Pulletz S, Elke G, Zhao Z, Zabel P, Weiler N, Frerichs I. Spatial and temporal heterogeneity of regional lung ventilation determined by electrical impedance tomography during pulmonary function testing. J Appl Physiol (1985). 2012 Oct;113(7):1154-61. doi: 10.1152/japplphysiol.01630.2011. Epub 2012 Aug 16.
PubMed 22898553Parolari A, Poggio P, Myasoedova V, Songia P, Bonalumi G, Pilozzi A, Pacini D, Alamanni F, Tremoli E. Biomarkers in Coronary Artery Bypass Surgery: Ready for Prime Time and Outcome Prediction? Front Cardiovasc Med. 2016 Jan 5;2:39. doi: 10.3389/fcvm.2015.00039. eCollection 2015.
PubMed 26779491Mendes RG, de Souza CR, Machado MN, Correa PR, Di Thommazo-Luporini L, Arena R, Myers J, Pizzolato EB, Borghi-Silva A. Predicting reintubation, prolonged mechanical ventilation and death in post-coronary artery bypass graft surgery: a comparison between artificial neural networks and logistic regression models. Arch Med Sci. 2015 Aug 12;11(4):756-63. doi: 10.5114/aoms.2015.48145. Epub 2015 Aug 11.
PubMed 26322087Kochamba GS, Yun KL, Pfeffer TA, Sintek CF, Khonsari S. Pulmonary abnormalities after coronary arterial bypass grafting operation: cardiopulmonary bypass versus mechanical stabilization. Ann Thorac Surg. 2000 May;69(5):1466-70. doi: 10.1016/s0003-4975(00)01142-5.
PubMed 10881824Chiumello D, Chevallard G, Gregoretti C. Non-invasive ventilation in postoperative patients: a systematic review. Intensive Care Med. 2011 Jun;37(6):918-29. doi: 10.1007/s00134-011-2210-8. Epub 2011 Mar 18.
PubMed 21424246Glossop AJ, Shephard N, Bryden DC, Mills GH. Non-invasive ventilation for weaning, avoiding reintubation after extubation and in the postoperative period: a meta-analysis. Br J Anaesth. 2012 Sep;109(3):305-14. doi: 10.1093/bja/aes270.
PubMed 22879654Perrin C, Jullien V, Venissac N, Berthier F, Padovani B, Guillot F, Coussement A, Mouroux J. Prophylactic use of noninvasive ventilation in patients undergoing lung resectional surgery. Respir Med. 2007 Jul;101(7):1572-8. doi: 10.1016/j.rmed.2006.12.002. Epub 2007 Jan 25.
PubMed 17257820
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Electrical Impedance Tomography in Evaluating the Effects of Noninvasive Ventilation in the Post-Operative Cardiac Surgery: Controlled and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03371628
- Acronym / sponsor ID
- Tomografia de Impedância
- Conditions
- Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 12 Dec 2017 (actual)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 13 Dec 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.
NTRODUCTION: cardiac surgery can lead to pulmonary complications such as hypoxemia and atelectasis. Noninvasive ventilation has been used to prevent and treat such complications. Electrical impedance tomography has been a useful tool in bedside evaluation of ventilation and pulmonary ventilation. OBJECTIVE: To compare the effects of non-invasive ventilation with oxygen therapy in cardiac post-operative patients. MATERIALS AND METHODS: It will be a randomized controlled clinical trial where patients will be divided into two groups: a group that will perform NIV for 1 hour and the group that will only use oxygen therapy. They will be evaluated through Electrical Impedance Tomography and arterial gasometry analysis just before extubation, soon after extubation, during the intervention and after the intervention for a period of 2 hours after extubation. EXPECTED RESULTS: It is expected that the NIV group will present higher pulmonary ventilation and aeration and better gas exchange than the oxygen therapy group, and that the time of therapeutic effect will be higher in the NIV group.
Detailed description
The proposal basically consists of Validation of the hypothesis: The use of Non-invasive Ventilation in patients in the postoperative cardiac surgery results in greater ventilation, greater aeration, and improved gas exchange when compared to the oxygen therapy group.
The use of noninvasive ventilation in the postoperative cardiac surgery has been widely used in clinical practice, but the evidence of the benefits of this technique in this population in relation to some criteria have not yet been elucidated in the scientific literature, such as the effect of NIV in ventilation and pulmonary ventilation, and how long does this effect last.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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 |
|---|---|---|
| Group VNI 1h | Experimental | Device: Non invasive ventilationIntervention: Non invasive ventilation, applied for 1 hour |
| Group O2 | No intervention | –Oxygen therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Immediate postoperative period of cardiac surgery
- age between 18 and 65 years
- BMI between 18.5 and 30 kg / m2
- Patients still intubated when admitted to the ICU
- without previous history of severe pulmonary diseases such as chronic obstructive pulmonary disease, pulmonary fibrosis, or chronic renal failure, or associated neuromuscular diseases
Key exclusion criteria (6 listed)
- Patients considered to be at risk for extubation failure (hypercapnia, more than failure in the autonomic test, AVM time greater than 72 hours, ineffective cough)
- Cardiopulmonary bypass time more than 150 minutes
- Hemodynamic instability (arrhythmias, cardiogenic shock, severe hypotension with SBP <90mmHg)
- Episodes of abdominal distension, nausea and vomiting
- Hypoxemia (PO2 <50mmHg with FiO2 50%) or hypercapnia (PaCO2> 55mmHg with pH <7.30)
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 |
|---|---|---|
| Non invasive ventilationNon invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway. | Device | Group VNI 1h |
Primary outcome
change in electrical impedance measures
Time frame: data recorded 5 minutes before extubation, 5 minutes after extubation, at the first 5 minutes of therapy, 25 to 30 minutes after beginning of therapy, 55 to 60 minutes after beginning of therapy, and 1,5 hour and 2 hours after beginning of therapy
impedance variation data recorded by impedance electrical tomography
1 secondary outcome
change in Blood gases analysis - PaO2 (mmHg), PaCO2 (mmHg), PaO2/FiO2
Time frame: recorded 5 minutes before extubation and 1 hour after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Background: PubMed 20068454Jaber S, Chanques G, Jung B. Postoperative noninvasive ventilation. Anesthesiology. 2010 Feb;112(2):453-61. doi: 10.1097/ALN.0b013e3181c5e5f2. No abstract available.
- Background: PubMed 23667066Rahmanian PB, Kroner A, Langebartels G, Ozel O, Wippermann J, Wahlers T. Impact of major non-cardiac complications on outcome following cardiac surgery procedures: logistic regression analysis in a very recent patient cohort. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):319-26; discussion 326-7. doi: 10.1093/icvts/ivt149. Epub 2013 May 10.
- Background: PubMed 19017864Zarbock A, Mueller E, Netzer S, Gabriel A, Feindt P, Kindgen-Milles D. Prophylactic nasal continuous positive airway pressure following cardiac surgery protects from postoperative pulmonary complications: a prospective, randomized, controlled trial in 500 patients. Chest. 2009 May;135(5):1252-1259. doi: 10.1378/chest.08-1602. Epub 2008 Nov 18.
- Background: PubMed 25374960Diodato M, Chedrawy EG. Coronary artery bypass graft surgery: the past, present, and future of myocardial revascularisation. Surg Res Pract. 2014;2014:726158. doi: 10.1155/2014/726158. Epub 2014 Jan 2.
- Background: PubMed 27298393Niclauss L. Techniques and standards in intraoperative graft verification by transit time flow measurement after coronary artery bypass graft surgery: a critical review. Eur J Cardiothorac Surg. 2017 Jan;51(1):26-33. doi: 10.1093/ejcts/ezw203. Epub 2016 Jun 13.
- Background: PubMed 26985228Yazdannik A, Bollbanabad HM, Mirmohammadsadeghi M, Khalifezade A. The effect of incentive spirometry on arterial blood gases after coronary artery bypass surgery (CABG). Iran J Nurs Midwifery Res. 2016 Jan-Feb;21(1):89-92. doi: 10.4103/1735-9066.174761.
- Background: PubMed 23582830Al Jaaly E, Fiorentino F, Reeves BC, Ind PW, Angelini GD, Kemp S, Shiner RJ. Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 Oct;146(4):912-8. doi: 10.1016/j.jtcvs.2013.03.014. Epub 2013 Apr 11.
- Background: PubMed 26446805Kotani T, Tanabe H, Yusa H, Saito S, Yamazaki K, Ozaki M. Electrical impedance tomography-guided prone positioning in a patient with acute cor pulmonale associated with severe acute respiratory distress syndrome. J Anesth. 2016 Feb;30(1):161-5. doi: 10.1007/s00540-015-2084-y. Epub 2015 Oct 7.
- Background: PubMed 22898553Vogt B, Pulletz S, Elke G, Zhao Z, Zabel P, Weiler N, Frerichs I. Spatial and temporal heterogeneity of regional lung ventilation determined by electrical impedance tomography during pulmonary function testing. J Appl Physiol (1985). 2012 Oct;113(7):1154-61. doi: 10.1152/japplphysiol.01630.2011. Epub 2012 Aug 16.
- Background: PubMed 26779491Parolari A, Poggio P, Myasoedova V, Songia P, Bonalumi G, Pilozzi A, Pacini D, Alamanni F, Tremoli E. Biomarkers in Coronary Artery Bypass Surgery: Ready for Prime Time and Outcome Prediction? Front Cardiovasc Med. 2016 Jan 5;2:39. doi: 10.3389/fcvm.2015.00039. eCollection 2015.
- Background: PubMed 26322087Mendes RG, de Souza CR, Machado MN, Correa PR, Di Thommazo-Luporini L, Arena R, Myers J, Pizzolato EB, Borghi-Silva A. Predicting reintubation, prolonged mechanical ventilation and death in post-coronary artery bypass graft surgery: a comparison between artificial neural networks and logistic regression models. Arch Med Sci. 2015 Aug 12;11(4):756-63. doi: 10.5114/aoms.2015.48145. Epub 2015 Aug 11.
- Background: PubMed 10881824Kochamba GS, Yun KL, Pfeffer TA, Sintek CF, Khonsari S. Pulmonary abnormalities after coronary arterial bypass grafting operation: cardiopulmonary bypass versus mechanical stabilization. Ann Thorac Surg. 2000 May;69(5):1466-70. doi: 10.1016/s0003-4975(00)01142-5.
- Individual participant dataSharing planned: Yes. Datas relative to the results of the use of electrical impedance tomography, besides blood gases and vital signs.
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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 Leite, specialist contact
Daniella C Brandão, PhD study director
UFPE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation 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 5 inclusion and 6 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 13 Dec 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 Alita L Novaes, specialist (+5581991610199, alitanovaes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in electrical impedance measures (time frame: data recorded 5 minutes before extubation, 5 minutes after extubation, at the first 5 minutes of therapy, 25 to 30 minutes after beginning of therapy, 55 to 60 minutes after beginning of therapy, and 1,5 hour and 2 hours after beginning of therapy). 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 NCT03371628, which also lists 32 linked publications.
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 13 Dec 2017.