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High Frequency Ventilation During Off Pump Coronary Artery Bypass Graft (CABG) (VHF)
This study is not yet open for participant recruitment.
Verified by Montreal Heart Institute, March 2009
First Received: March 16, 2009   Last Updated: March 24, 2009   History of Changes
Sponsored by: Montreal Heart Institute
Information provided by: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00863044
  Purpose

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.


Condition Intervention Phase
Coronary Artery Bypass
 Procedure: Apnea
Procedure: High frequency ventilation
 Phase IV

MedlinePlus related topics: Coronary Artery Bypass Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety Study
Official Title: Impact of High Frequency Ventilation During Coronary Anastomosis in Off Pump Coronary Artery Bypass.

Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • cerebral oxygen saturation [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hemodynamic parameters [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
High frequency ventilation: Active Comparator
high frequency ventilation
Procedure: High frequency ventilation
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.
Apnea: Placebo Comparator
lung ventilation will be stopped during distal anastomosis as is commonly done
Procedure: Apnea
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • Patients able to give consent with knowledge of french or english language.

Exclusion Criteria:

  • Patients undergoing emergency surgery.
  • Patients with an intra aortic balloon pump.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863044

Contacts
Contact: Alain Deschamps, MD 514-376-3330 ext 3732 alain.deschamps@icm-mhi.org

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Investigators
Principal Investigator: Alain Deschamps, MD FRCPC University of Montreal
  More Information

Publications:
Oberg PA, Sjöstrand 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. No abstract available.
Heijman K, Heijman L, Jonzon A, Sedin G, Sjöstrand U, Widman B. High frequency positive pressure ventilation during anaesthesia and routine surgery in man. Acta Anaesthesiol Scand. 1972;16(3):176-87. No abstract available.
3) Ratzenhofer-Komenda B,Prause G,Offner A,Smolle-Juttner FM et al Intra-opearative application of HFV in thoracic surgery Acta Anesthesiol Scand Suppl .1996 : 109 : 149-53
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Ueno 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.
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Reich 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.
Tremblay 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.
Deschamps 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.
Malouf JF, Enriquez-Sarano M, Pellikka PA, Oh JK, Bailey KR, Chandrasekaran K, Mullany CJ, Tajik AJ. Severe pulmonary hypertension in patients with severe aortic valve stenosis: clinical profile and prognostic implications. J Am Coll Cardiol. 2002 Aug 21;40(4):789-95.
Mishra M, Chauhan R, Sharma KK, Dhar A, Bhise M, Dhole S, Omar A, Kasliwal RR, Trehan N. Real-time intraoperative transesophageal echocardiography--how useful? Experience of 5,016 cases. J Cardiothorac Vasc Anesth. 1998 Dec;12(6):625-32.
Bezold LI, Pignatelli R, Altman CA, Feltes TF, Gajarski RJ, Vick GW 3rd, Ayres NA. Intraoperative transesophageal echocardiography in congenital heart surgery. The Texas Children's Hospital experience. Tex Heart Inst J. 1996;23(2):108-15. No abstract available.
Komukai K, Shibata T, Mochizuki S. C-reactive protein is related to impaired oxygenation in patients with acute aortic dissection. Int Heart J. 2005 Sep;46(5):795-9.
Puls A, Pollok-Kopp B, Wrigge H, Quintel M, Neumann P. Effects of a single-lung recruitment maneuver on the systemic release of inflammatory mediators. Intensive Care Med. 2006 Jul;32(7):1080-5. Epub 2006 May 9.
Lau DC, Dhillon B, Yan H, Szmitko PE, Verma S. Adipokines: molecular links between obesity and atheroslcerosis. Am J Physiol Heart Circ Physiol. 2005 May;288(5):H2031-41. Epub 2005 Jan 14. Review.
Chin KM, Channick RN, Kim NH, Rubin LJ. Central venous blood oxygen saturation monitoring in patients with chronic pulmonary arterial hypertension treated with continuous IV epoprostenol: correlation with measurements of hemodynamics and plasma brain natriuretic peptide levels. Chest. 2007 Sep;132(3):786-92. Epub 2007 Jul 23.
Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. No abstract available.
Denault AY, Couture P, Buithieu J, Haddad F, Carrier M, Babin D, Levesque S, Tardif JC. Left and right ventricular diastolic dysfunction as predictors of difficult separation from cardiopulmonary bypass. Can J Anaesth. 2006 Oct;53(10):1020-9.
Deschamps 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.
[No authors listed] Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
Pichot V, Gaspoz JM, Molliex S, Antoniadis A, Busso T, Roche F, Costes F, Quintin L, Lacour JR, Barthélémy JC. Wavelet transform to quantify heart rate variability and to assess its instantaneous changes. J Appl Physiol. 1999 Mar;86(3):1081-91.
Malouf JF, Enriquez-Sarano M, Pellikka PA, Oh JK, Bailey KR, Chandrasekaran K, Mullany CJ, Tajik AJ. Severe pulmonary hypertension in patients with severe aortic valve stenosis: clinical profile and prognostic implications. J Am Coll Cardiol. 2002 Aug 21;40(4):789-95.
Dumesnil JG, Pibarot P. Prosthesis-patient mismatch and clinical outcomes: the evidence continues to accumulate. J Thorac Cardiovasc Surg. 2006 May;131(5):952-5. No abstract available.
Mishra M, Chauhan R, Sharma KK, Dhar A, Bhise M, Dhole S, Omar A, Kasliwal RR, Trehan N. Real-time intraoperative transesophageal echocardiography--how useful? Experience of 5,016 cases. J Cardiothorac Vasc Anesth. 1998 Dec;12(6):625-32.
Bezold LI, Pignatelli R, Altman CA, Feltes TF, Gajarski RJ, Vick GW 3rd, Ayres NA. Intraoperative transesophageal echocardiography in congenital heart surgery. The Texas Children's Hospital experience. Tex Heart Inst J. 1996;23(2):108-15. No abstract available.
Chee TS, Quek SS, Ding ZP, Chua SM. Clinical utility, safety, acceptability and complications of transoesophageal echocardiography (TEE) in 901 patients. Singapore Med J. 1995 Oct;36(5):479-83.
Khoury AF, Afridi I, Quiñones MA, Zoghbi WA. Transesophageal echocardiography in critically ill patients: feasibility, safety, and impact on management. Am Heart J. 1994 May;127(5):1363-71.
Haddad F, Denault AY, Couture P, Cartier R, Pellerin M, Levesque S, Lambert J, Tardif JC. Right ventricular myocardial performance index predicts perioperative mortality or circulatory failure in high-risk valvular surgery. J Am Soc Echocardiogr. 2007 Sep;20(9):1065-72. Epub 2007 Jun 12.

Responsible Party: University of Montreal ( Alain Deschamps )
Study ID Numbers: 08-1032
Study First Received: March 16, 2009
Last Updated: March 24, 2009
ClinicalTrials.gov Identifier: NCT00863044     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
off pump coronary bypass
high frequency ventilation
cerebral oxygen saturation
vasopressors used
 right and left ventricular function
arterial blood pressure
heart rate

Study placed in the following topic categories:
Vasoconstrictor Agents
Benzocaine

ClinicalTrials.gov processed this record on May 07, 2009



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