Coronary Artery Bypass GraftPhase 4VHFNCT00863044
High Frequency Ventilation During Off Pump Coronary Artery Bypass Graft (CABG)
A Phase 4 study testing Apnea and High frequency ventilation in people with Coronary Artery Bypass Graft, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
This study is to test the safety of high frequency-low volume ventilation during off pump coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral oxygenation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft
- What is being tested?
- Apnea and High frequency ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Jun 2012
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- Patients able to give consent with knowledge of french or english language.
Who cannot join
- Patients undergoing emergency surgery.
- Patients with an intra aortic balloon pump.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of High Frequency Ventilation During Coronary Anastomosis in Off Pump Coronary Artery Bypass.
This study is to test the safety of high frequency-low volume ventilation during off pump coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral oxygenation.
Read the detailed description
Ventilatory protocol: Patients will be randomized to either the apnea group or the HFV group. In the HFV group the patients will be ventilated using a tidal volume of 1.5 ml per kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the distal anastomosis of the coronaries.The same surgeon will perform all surgeries. In the Control group, ventilation will be stopped for the duration of the anastomosis as it's done currently. At all other times during the surgery, the ventilatory parameters will be adjusted to maintain a PaCO2 between 40 and 45 mmHg.
The anesthesia protocol for the off pump coronary artery bypass will be as follows: premedication will be left at the discretion of the anesthesiologist. In the operating room, the patient will be instrumented with a radial arterial line before induction. Induction will consist of a bolus of 1.0 mcg per Kg of Sufentanil. Anesthesia will be maintained with 1mcg per Kg per hour of Sufentanil. One per cent Isoflurane will be used as hemodynamic parameters allow. Rocuronium 0.7 mg per Kg will be used to facilitate endotracheal intubation. Following endotracheal intubation the patients will monitored with a pulmonary artery catheter and a femoral arterial line. A perfusionist will be on standby at all times for possible conversion to extracorporeal circulation.
Measures to effect:
Routine baseline laboratory investigations will be performed at admission of the patient to the ward.
Hemodynamic parameters:
Arterial blood pressure, heart rate, pulmonary artery pressure, right ventricular pressure will be recorded five minutes intervals throughout the surgery.
Ventilatory parameters and blood gases:
End tidal CO2 and pulse oxymetry will be recorded at five minutes intervals throughout the surgery.
Arterial blood gases will be performed after induction, before and after each distal coronary anastomosis and when judged necessary. The type and time for each anastomosis will be noted.
C-reactive protein and brain natriuretic peptide:
Measurements of CRP and BNP will be perform at admission, after induction of anesthesia, in the intensive care unit after the surgery and 24 hrs after admission to the intensive care unit.
We will use the serum for measure of CRP.CRP will be measured using the Dade Behring N High Sensitivity CRP assay (Dade Behring Diagnostics,Marburg,Germany) on the BN ProSpec Nephelometer (Dade Behring Diagnostics).The assay will use monoclonal anti-CRP antibodies coated to polystyrene particles and a human calibrator traceable to the WHO reference material. We will use the Heparinised Plasma for measure of NT Pro-BNP.NT Pro-BNP will be measure by electrochemiluminescence immunoassay using the Roche Pro BNP assay (Roche Diagnostics , Mannheim,Germany) on the ElecSys 2010 analyzer (Roche Diagnostics).This assay will use two polyclonal antibodies in a sandwich format.
Cerebral Oximetry Monitoring:
Cerebral oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanetics Corporation, Troy, MI) will be performed on all patients. After cleaning adjacent skin area with alcohol, an adhesive optode pad will be placed over each front-temporal area. Resting baseline rSO2 values will be obtained after waiting at least 1 min after placement of sensors once values had stabilized, with patient resting quietly and receiving 3-5 L of O2/min by nasal cannula. Continuous rSO2 values will be store on a floppy disk with a 15 s update for the duration of the intraoperative period. With application of the chest dressing, and before leaving the OR, monitoring will be discontinued and optodes will be removed.
Transesophageal echocardiographic (TEE) measurements:
A comprehensive TEE examination will be performed for all patients as it's done routinely(25). Specific TEE measurements as recommended be the ASE will be perform before and after distal coronary anastomosis(26). RVMPI will be defined as the sum of isovolumic contraction time and isovolumic relaxation time divided by the ejection time and the normal value is 0.28±0.04). RV MPI will be measured using both pulse wave and tissue Doppler imaging from a deep transgastric view and upper esophageal view. Right ventricular FAC % will be measure in 4 chambers view and calculated as RV change in area in diastole minus RV change in area in Systole divided by the calculated RV area in Diastole (37).
Analysis of HR and BP variability:
Baseline HR and BP variability will be analysed using wavelet transformation (27). The extraction of characteristic frequencies, or specific oscillations, of a signal that is composed of the consecutive R-R intervals for HR variability analysis, or consecutive systolic blood pressures for BP variability analysis, is used. The analysis will be made using MATLAB® and the dedicated toolbox software Wavelab. High frequency power of the HR variability is indicative of changes in parasympathetic nervous system. Total power of the BP variability signal is used as a measure of sympathetic outflow.
- Conditions
- Coronary Artery Bypass Graft
- Being tested
- Apnea, High frequency ventilation
- Keywords
- off pump coronary bypass, high frequency ventilation, cerebral oxygen saturation, vasopressors used, right and left ventricular function, arterial blood pressure, heart rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApneaProcedure or surgery
Also called apnea during anastomosis in off pump CABG
Ventilation will be stopped for the duration of the anastomosis as it's done currently. At all other times during the surgery, the ventilatory parameters will be adjusted to maintain a PaCO2 between 40 and 45 mmHg.
High frequency ventilationProcedure or surgery
The patients will be ventilated using a tidal volume of 1.5 ml per Kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the distal anastomosis of the coronaries.
| Study group | Role | What they receive |
|---|---|---|
| High frequency ventilation | Active comparator | high frequency ventilation Receives: Procedure: High frequency ventilation |
| Apnea | Placebo comparator | lung ventilation will be stopped during distal anastomosis as is commonly done Receives: Procedure: Apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oxygen saturation
Measured: during surgery
Secondary outcomes (1)
hemodynamic parameters
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2011
- Study completionJun 2012
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 Coronary Artery Bypass GraftStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Deschamps, Montreal Heart Institute
- Investigators
- Alain Deschamps, MD FRCPC, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863044
- Sponsor's protocol ID
- 08-1032
- Acronym
- VHF
- Status last verified
- Mar 2016
- First submitted
- 16 Mar 2009
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Oberg PA, Sjostrand U. Studies of blood-pressure regulation. I. Common-carotid-artery clamping in studies of the carotid-sinus baroreceptor control of the systemic blood pressure. Acta Physiol Scand. 1969 Mar;75(3):276-86. doi: 10.1111/j.1748-1716.1969.tb04381.x. No abstract available.
PubMed 5790220Heijman K, Heijman L, Jonzon A, Sedin G, Sjostrand U, Widman B. High frequency positive pressure ventilation during anaesthesia and routine surgery in man. Acta Anaesthesiol Scand. 1972;16(3):176-87. doi: 10.1111/j.1399-6576.1972.tb00588.x. No abstract available.
PubMed 4566465Ratzenhofer-Komenda B, Prause G, Offner A, Smolle-Juttner FM. Intraoperative application of high frequency ventilation in thoracic surgery. Acta Anaesthesiol Scand Suppl. 1996;109:149-53. No abstract available.
PubMed 8901989Babinski MF, Smith RB. High frequency ventilation. Int Anesthesiol Clin. 1986 Spring;24(1):75-92. doi: 10.1097/00004311-198602410-00008. No abstract available.
PubMed 3512455Glenski JA, Crawford M, Rehder K. High-frequency, small-volume ventilation during thoracic surgery. Anesthesiology. 1986 Feb;64(2):211-4. doi: 10.1097/00000542-198602000-00014.
PubMed 3511770Gallagher TJ, Klain MM, Carlon GC. Present status of high frequency ventilation. Crit Care Med. 1982 Sep;10(9):613-7. doi: 10.1097/00003246-198209000-00013. No abstract available.
PubMed 7049574Rouby JJ, Simonneau G, Benhamou D, Sartene R, Sardnal F, Deriaz H, Duroux P, Viars P. Factors influencing pulmonary volumes and CO2 elimination during high-frequency jet ventilation. Anesthesiology. 1985 Nov;63(5):473-82. doi: 10.1097/00000542-198511000-00002.
PubMed 3931506Heres EK, Shulman MS, Krenis LJ, Moon R. High-frequency ventilation with a conventional anesthetic ventilator during cardiac surgery. J Cardiothorac Vasc Anesth. 1995 Feb;9(1):63-5. doi: 10.1016/s1053-0770(05)80057-6. No abstract available.
PubMed 7718756Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
PubMed 17179242Kadoi Y, Kawahara F, Saito S, Morita T, Kunimoto F, Goto F, Fujita N. Effects of hypothermic and normothermic cardiopulmonary bypass on brain oxygenation. Ann Thorac Surg. 1999 Jul;68(1):34-9. doi: 10.1016/s0003-4975(99)00306-9.
PubMed 10421111Ueno T, Ikeda K, Matsuyama S. Characteristic changes in cerebral perfusion during on-pump and off-pump coronary artery surgery. Jpn J Thorac Cardiovasc Surg. 2005 Mar;53(3):138-42. doi: 10.1007/s11748-005-0019-5.
PubMed 15828293Tuman KJ, McCarthy RJ, March RJ, Najafi H, Ivankovich AD. Morbidity and duration of ICU stay after cardiac surgery. A model for preoperative risk assessment. Chest. 1992 Jul;102(1):36-44. doi: 10.1378/chest.102.1.36.
PubMed 1623792Reich DL, Bodian CA, Krol M, Kuroda M, Osinski T, Thys DM. Intraoperative hemodynamic predictors of mortality, stroke, and myocardial infarction after coronary artery bypass surgery. Anesth Analg. 1999 Oct;89(4):814-22. doi: 10.1097/00000539-199910000-00002.
PubMed 10512249Tremblay NA, Hardy JF, Perrault J, Carrier M. A simple classification of the risk in cardiac surgery: the first decade. Can J Anaesth. 1993 Feb;40(2):103-11. doi: 10.1007/BF03011305.
PubMed 8443847Deschamps A, Kaufman I, Backman SB, Plourde G. Autonomic nervous system response to epidural analgesia in laboring patients by wavelet transform of heart rate and blood pressure variability. Anesthesiology. 2004 Jul;101(1):21-7. doi: 10.1097/00000542-200407000-00006.
PubMed 15220767
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of High Frequency Ventilation During Coronary Anastomosis in Off Pump Coronary Artery Bypass.
- ClinicalTrials.gov ID
- NCT00863044
- Acronym / sponsor ID
- VHF / 08-1032
- Conditions
- Coronary Artery Bypass Graft
- Keywords
- off pump coronary bypass, high frequency ventilation, cerebral oxygen saturation, vasopressors used, right and left ventricular function, arterial blood pressure, heart rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Mar 2009 (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 is to test the safety of high frequency-low volume ventilation during off pump coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral oxygenation.
Detailed description
Ventilatory protocol: Patients will be randomized to either the apnea group or the HFV group. In the HFV group the patients will be ventilated using a tidal volume of 1.5 ml per kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the distal anastomosis of the coronaries.The same surgeon will perform all surgeries. In the Control group, ventilation will be stopped for the duration of the anastomosis as it's done currently. At all other times during the surgery, the ventilatory parameters will be adjusted to maintain a PaCO2 between 40 and 45 mmHg.
The anesthesia protocol for the off pump coronary artery bypass will be as follows: premedication will be left at the discretion of the anesthesiologist. In the operating room, the patient will be instrumented with a radial arterial line before induction. Induction will consist of a bolus of 1.0 mcg per Kg of Sufentanil. Anesthesia will be maintained with 1mcg per Kg per hour of Sufentanil. One per cent Isoflurane will be used as hemodynamic parameters allow. Rocuronium 0.7 mg per Kg will be used to facilitate endotracheal intubation. Following endotracheal intubation the patients will monitored with a pulmonary artery catheter and a femoral arterial line. A perfusionist will be on standby at all times for possible conversion to extracorporeal circulation.
Measures to effect:
Routine baseline laboratory investigations will be performed at admission of the patient to the ward.
Hemodynamic parameters:
Arterial blood pressure, heart rate, pulmonary artery pressure, right ventricular pressure will be recorded five minutes intervals throughout the surgery.
Ventilatory parameters and blood gases:
End tidal CO2 and pulse oxymetry will be recorded at five minutes intervals throughout the surgery.
Arterial blood gases will be performed after induction, before and after each distal coronary anastomosis and when judged necessary. The type and time for each anastomosis will be noted.
C-reactive protein and brain natriuretic peptide:
Measurements of CRP and BNP will be perform at admission, after induction of anesthesia, in the intensive care unit after the surgery and 24 hrs after admission to the intensive care unit.
We will use the serum for measure of CRP.CRP will be measured using the Dade Behring N High Sensitivity CRP assay (Dade Behring Diagnostics,Marburg,Germany) on the BN ProSpec Nephelometer (Dade Behring Diagnostics).The assay will use monoclonal anti-CRP antibodies coated to polystyrene particles and a human calibrator traceable to the WHO reference material. We will use the Heparinised Plasma for measure of NT Pro-BNP.NT Pro-BNP will be measure by electrochemiluminescence immunoassay using the Roche Pro BNP assay (Roche Diagnostics , Mannheim,Germany) on the ElecSys 2010 analyzer (Roche Diagnostics).This assay will use two polyclonal antibodies in a sandwich format.
Cerebral Oximetry Monitoring:
Cerebral oxymetry (rSO2) using near infrared spectroscopy (NIRS, Invos 5100; Somanetics Corporation, Troy, MI) will be performed on all patients. After cleaning adjacent skin area with alcohol, an adhesive optode pad will be placed over each front-temporal area. Resting baseline rSO2 values will be obtained after waiting at least 1 min after placement of sensors once values had stabilized, with patient resting quietly and receiving 3-5 L of O2/min by nasal cannula. Continuous rSO2 values will be store on a floppy disk with a 15 s update for the duration of the intraoperative period. With application of the chest dressing, and before leaving the OR, monitoring will be discontinued and optodes will be removed.
Transesophageal echocardiographic (TEE) measurements:
A comprehensive TEE examination will be performed for all patients as it's done routinely(25). Specific TEE measurements as recommended be the ASE will be perform before and after distal coronary anastomosis(26). RVMPI will be defined as the sum of isovolumic contraction time and isovolumic relaxation time divided by the ejection time and the normal value is 0.28±0.04). RV MPI will be measured using both pulse wave and tissue Doppler imaging from a deep transgastric view and upper esophageal view. Right ventricular FAC % will be measure in 4 chambers view and calculated as RV change in area in diastole minus RV change in area in Systole divided by the calculated RV area in Diastole (37).
Analysis of HR and BP variability:
Baseline HR and BP variability will be analysed using wavelet transformation (27). The extraction of characteristic frequencies, or specific oscillations, of a signal that is composed of the consecutive R-R intervals for HR variability analysis, or consecutive systolic blood pressures for BP variability analysis, is used. The analysis will be made using MATLAB® and the dedicated toolbox software Wavelab. High frequency power of the HR variability is indicative of changes in parasympathetic nervous system. Total power of the BP variability signal is used as a measure of sympathetic outflow.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High frequency ventilation | Active comparator | Procedure: High frequency ventilationhigh frequency ventilation |
| Apnea | Placebo comparator | Procedure: Apnealung ventilation will be stopped during distal anastomosis as is commonly done |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years.
- Patients able to give consent with knowledge of french or english language.
Key exclusion criteria (2 listed)
- Patients undergoing emergency surgery.
- Patients with an intra aortic balloon pump.
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 |
|---|---|---|
| ApneaAlso: apnea during anastomosis in off pump CABGVentilation will be stopped for the duration of the anastomosis as it's done currently. At all other times during the surgery, the ventilatory parameters will be adjusted to maintain a PaCO2 between 40 and 45 mmHg. | Procedure or surgery | Apnea |
| High frequency ventilationThe patients will be ventilated using a tidal volume of 1.5 ml per Kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the distal anastomosis of the coronaries. | Procedure or surgery | High frequency ventilation |
Primary outcome
cerebral oxygen saturation
Time frame: during surgery
1 secondary outcome
hemodynamic parameters
Time frame: during 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 16 Mar 2016.
- Background: PubMed 5790220Oberg PA, Sjostrand U. Studies of blood-pressure regulation. I. Common-carotid-artery clamping in studies of the carotid-sinus baroreceptor control of the systemic blood pressure. Acta Physiol Scand. 1969 Mar;75(3):276-86. doi: 10.1111/j.1748-1716.1969.tb04381.x. No abstract available.
- Background: PubMed 4566465Heijman K, Heijman L, Jonzon A, Sedin G, Sjostrand U, Widman B. High frequency positive pressure ventilation during anaesthesia and routine surgery in man. Acta Anaesthesiol Scand. 1972;16(3):176-87. doi: 10.1111/j.1399-6576.1972.tb00588.x. No abstract available.
- Background: PubMed 8901989Ratzenhofer-Komenda B, Prause G, Offner A, Smolle-Juttner FM. Intraoperative application of high frequency ventilation in thoracic surgery. Acta Anaesthesiol Scand Suppl. 1996;109:149-53. No abstract available.
- Background: PubMed 3512455Babinski MF, Smith RB. High frequency ventilation. Int Anesthesiol Clin. 1986 Spring;24(1):75-92. doi: 10.1097/00004311-198602410-00008. No abstract available.
- Background: PubMed 3511770Glenski JA, Crawford M, Rehder K. High-frequency, small-volume ventilation during thoracic surgery. Anesthesiology. 1986 Feb;64(2):211-4. doi: 10.1097/00000542-198602000-00014.
- Background: PubMed 7049574Gallagher TJ, Klain MM, Carlon GC. Present status of high frequency ventilation. Crit Care Med. 1982 Sep;10(9):613-7. doi: 10.1097/00003246-198209000-00013. No abstract available.
- Background: PubMed 3931506Rouby JJ, Simonneau G, Benhamou D, Sartene R, Sardnal F, Deriaz H, Duroux P, Viars P. Factors influencing pulmonary volumes and CO2 elimination during high-frequency jet ventilation. Anesthesiology. 1985 Nov;63(5):473-82. doi: 10.1097/00000542-198511000-00002.
- Background: PubMed 7718756Heres EK, Shulman MS, Krenis LJ, Moon R. High-frequency ventilation with a conventional anesthetic ventilator during cardiac surgery. J Cardiothorac Vasc Anesth. 1995 Feb;9(1):63-5. doi: 10.1016/s1053-0770(05)80057-6. No abstract available.
- Background: PubMed 17179242Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.
- Background: PubMed 10421111Kadoi Y, Kawahara F, Saito S, Morita T, Kunimoto F, Goto F, Fujita N. Effects of hypothermic and normothermic cardiopulmonary bypass on brain oxygenation. Ann Thorac Surg. 1999 Jul;68(1):34-9. doi: 10.1016/s0003-4975(99)00306-9.
- Background: PubMed 15828293Ueno T, Ikeda K, Matsuyama S. Characteristic changes in cerebral perfusion during on-pump and off-pump coronary artery surgery. Jpn J Thorac Cardiovasc Surg. 2005 Mar;53(3):138-42. doi: 10.1007/s11748-005-0019-5.
- Background: PubMed 1623792Tuman KJ, McCarthy RJ, March RJ, Najafi H, Ivankovich AD. Morbidity and duration of ICU stay after cardiac surgery. A model for preoperative risk assessment. Chest. 1992 Jul;102(1):36-44. doi: 10.1378/chest.102.1.36.
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Coronary Artery Bypass Graft (CABG)
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.
Alain Deschamps, MD FRCPC principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apnea and High frequency ventilation in people with Coronary Artery Bypass Graft, run by Montreal Heart Institute at 1 site in Canada.
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 2 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 16 Mar 2016. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cerebral oxygen saturation (time frame: during surgery). 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 NCT00863044, 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 16 Mar 2016.