Topic: Clinical Trial
Prospective Evaluation of Elective Tube Exchange in Patients Requiring Prolonged Mechanical Ventilation (PREVENT): Pilot Study.
Assiri Amer1; McKechnie Kyle2; Muscedere John3
1Intensive Care Unit, Aseer Central Hospital, Abha, Saudi Arabia; 2Critical Care, Northern Ontario School of Medicine, Sudbury, ON, Canada; 3Critical Care Medicine Dep., Queen's university, Kingston, ON, Canada
Abstract:
PURPOSE:
Endotracheal tubes (ETT) with subglottic suctioning drainage (SSD) in mechanically ventilated patients have been demonstrated to reduce Ventilator Associated Pneumonia and may improve clinical outcomes. The best management strategy is unknown for patients admitted with standard ETTs who require ongoing mechanical ventilation. One strategy may be to electively replace the ETT but the benefits of reduced VAP risk must be balanced by the risk of tube exchange. A randomized controlled trial (RCT) would be required to evaluate the risks and benefits. In preparation, we conducted a pilot study whose primary objective was to determine the safety and feasibility of ETT exchange in patients presenting with a standard ETT to one with SSD.
METHODS:
We included adult patients (> 18 years) with standard ETTs intubated <36 hours with expected ongoing tracheal intubation for >72 hours. After consent, ETT exchange was done by an ICU attending/fellow using an exchange catheter. Sedation and paralysis were as per the procedural physician. Data were collected pre, during, and post procedure. Follow up was till ICU discharge or death
RESULTS:
We enrolled 20 patients, Characteristics were [mean (SD)]: age 64.5 years (11.4), APACHE II 29.1 (8.4), 17 were medical. At tube exchange, FiO2 was 0.37 (0.10), PEEP was 8.4 cm H2O (2.9). ICU length of stay was 19.1 days (17.25). ICU mortality was 30%, no deaths were related to ETT exchange. Only 1 complication, in 1 patient, was observed; a transient drop in oxygen saturation during the procedure. The study was stopped early due to lack of recruitment when institutional adoption of ETTs with SSD became the norm.
CONCLUSIONS:
In this pilot study, elective ETT change was safe and feasible. A RCT on larger scale may be feasible in centers who have not adopted ETTs with SSD although further study may not be necessary if their adoption becomes the norm.
References:
Muscedere J., Day A., Heyland D.K. Mortality, attributable mortality and time to clinical event analysis as endpoints for trials of Ventilator Associated Pneumonia and Hospital Acquired Pneumonia. Clinical Infectious Diseases. 51 Suppl 1:S120-5, 2010.
Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Critical Care Medicine. 2005;33:2184-93.
Kuti E., Patel A., Coleman C. Impact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: A meta-analysis. J of Crit Care. 2008; 23: 91–100.
Muscedere JG, Martin CM, Heyland DK. The impact of ventilator associated pneumonia on the Canadian health care system. J Crit Care.2008; 23:5-10.
Bergmans D, Bonten M, Gaillard C, Van Tiel A, Van der Geest S, De Leeuw P, Stobberingh E. Indications for antibiotic use in ICU patients: A one-year prospective surveillance. Journal of Antimicrobial Chemotherapy. 1997; 39: 527-535.
Edwards J, Peterson K, Mu Y, et al. National Healthcare Safety Network (NHSN) report: Data summary for 2006 through 2008, issued December 2009. Am J Infect Control 2009; 37: 783-805.
Morrow L, Malesker M, Farrington K. Diagnostic criteria and Intensity of surveillance affect reportable ventilator associated pneumonia rates. Chest 2006; 130 (4) Supplement: 101S
Drees M., Hausman S., Rogers A., Freeman L., Wroten K. Underestimating the impact of ventilator-associated pneumonia by use of surveillance data. Infection Control and Hospital Epidemiology. 2010; 31: 650-652.
John Muscedere, Tasmin Sinuff Co-Principal Investigators. Active OBservational Study of the Adoption and Transfer of Clinical Practice Guidelines through Education, for Ventilator Associated Pneumonia (ABATE VAP Study).
Van Saene H., Peric M., De La Cal M., Silvestri L.: Pneumonia during Mechanical Ventilation. Anestiologie a Intenzivni Medicina 2004; 15: 89-100.
Chastre J. Fagon J. Ventilator-Associated Pneumonia. Am. J. of Respir Crit Care Med. 2002; 165: 867- 903.
du Moulin GC, Paterson DG, Hedley-Whyte J, Lisbon A. Aspiration of gastric bacteria in antacid-treated patients: a frequent cause of postoperative colonisation of the airway. Lancet 1982;1:242–245
Young PJ, Ridley SA. Ventilator-associated pneumonia. Diagnosis, pathogenesis and prevention. Anaesthesia 1999;54(12):1183-97.
Heyland DK, Mandell LA. Gastric colonization and Nosocomial Pneumonia: Evidence for causation. Chest 1992;101:187-93.
Heyland DK, Wood G, Cook DJ for the Canadian Critical Care Trials Group. Is the stomach an important source of tracheal contamination and subsequent pneumonia? Clinical Intensive Care 2001;12(1):29-36.
Inglis TJ, Millar MR, Jones JG, Robinson DA. Tracheal tube biofilm as a source of bacterial colonization of the lung. J Clin Microbiol 1989;27:2014–2018
Adair CG, Gorman SP, Feron BM, Byers LM, Jones DS, Goldsmith CE, Moore JE, Kerr JR, Curran MD, Hogg G, et al. Implications of endotracheal tube biofilm for ventilator-associated pneumonia. Intensive Care Med 1999;25:1072–1076
Dullenkopf A, Gerber A, Weiss M. Fluid leakage past tracheal tube cuffs: evaluation of the new Microcuff endotracheal tube. Intensive Care Med 2003; 29: 1849–1853.
Greene R, Thompson S, Jantsch HS, et al: Detection of pooled secretions above endotracheal-tube cuffs: value of plain radiographs in sheep cadavers and patients. Am J Roentgenol 1994; 163: 1333-7.
Mahul P, Auboyer C, Jospe R, et al: Prevention of nosocomial pneumonia in intubated patients: respective role of mechanical subglottic secretions drainage and stress ulcer prophylaxis. Intensive Care Med 1992;18: 20-5.
Dezfulian, C, Shojania K, et al: Subglottic secretion drainage for preventing ventilator-associated pneumonia: a meta-analysis. Am J Med 2005; 118: 11-8.
Muscedere J., O. Rewa, K. MaKechnie, D. Laporta, X. Jiang. Heyland D.K. Sub-Glottic Secretion for the prevention of ventilator associated pneumonia; A systematic review and meta-analysis. Critical Care Medicine, 2011; 39(8): xxx
Krein SL, Kowalski CP, Damschroder L, et al: Preventing ventilator-associated pneumonia in the United States: a multicenter mixed-methods study. Infect Control Hosp Epidemiol 2008; 29: 933-40.
Anonymous, www.ihi.org/IHI/Topics/CriticalCare/IntensiveCare/Changes/ImplementtheVentilatorBundle.htm, Accessed September 2010.
Berra, L et al. Evaluation of continuous aspiration of subglottic secretion in an in vivo study. Crit Care Med 2004; 32 (10): 2071-78.
Petering HG. Pharmacology and toxicology of heavy metals: Silver. Pharmacol Ther 1976; 1: 127-130.
Gabriel M, Sawant A, Simmons R, Ahearn D. Effects of silver on adherence of bacteria to urinary catheters: in vitro studies. Curr Microbiol 1995; 30: 17-22.
Rello, J., B. Afessa, et al. Activity of a silver-coated endotracheal tube in preclinical models of ventilator-associated pneumonia and a study after extubation. Crit Care Med 2010; 38: 1135-40.
Rello J, Kollef M, Diaz E et al. Reduced Burden of bacterial airway colonization with a novel silver-coated endotracheal tube in a randomized multiple center feasibility study. Crit Care Med 2006; 34: 2766-2722.
Kollef MH, Afessa B, Anzueto A et al and the NASCENT Investigation Group. Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial. JAMA 2008; 300: 805-13.
Morrow L, Jarrett J, Malesker M et al. Systematic Use of a Silver-Coated Endotracheal Tube Reduces Rates of Ventilator Associated Pneumonia. ATS 2009.
Torres A, Gatell J, Aznar E et al. Re-intubation increases the risk of nosocomial pneumonia in patients needing mechanical ventilation Am. J. Respir. Crit. Care Med., 1995; 152: 137-141.
Muscedere J, Dodek P., Keenan S., Fowler R., Cook D., Heyland D. for the VAP Guidelines Committee and the Canadian Critical Care Trials Group. Comprehensive Evidence-Based Clinical Practice Guidelines for Ventilator Associated Pneumonia: Prevention. J of Critical Care, 2008; 23: 126-137
Heyland D., Dodek P., Day A. Muscedere J., Cook D. for the Canadian Critical Care Trials Group. A Randomized Trial Of Diagnostic Techniques For Suspected Ventilator-Associated Pneumonia. New Eng J of Medicine, N Engl J Med 2006;355:2619-30.
Heyland, DK, Dodek P, Muscedere J, Cook D. for the Canadian Critical Care Trials Group.: A randomized trial of combination versus monotherapy for the empiric treatment of suspected ventilator-associated pneumonia. Crit Care Med,.DOI: 10.1097/01.CCM.0B013E31816203D6
Muscedere J, Dodek P., Keenan S., Fowler R., Cook D., Heyland D. for the VAP Guidelines Committee and the Canadian Critical Care Trials Group. Comprehensive Evidence-Based Clinical Practice Guidelines for Ventilator Associated Pneumonia: Diagnosis and Treatment. J of Critical Care, 2008; 23: 138-147.
ABATE VAP Trial, Funded by Canadian Institutes of Health Research, Principal Investigators: Dr. John Muscedere and Tasmin Sinuff
Van An Teijlingen E., Hundley V. The importance of pilot studies. Nursing Standard 2002; 16: 33-36.
Arnold D., Burns K., Adhikari N., Kho M., Meade M., Cook D. et al. The design and interpretation of pilot trials in clinical research in critical care. Critical Care Medicine 2009; 37(Suppl.):S69-74.
Canadian Institutes of Health Research. Available at: www.cihr.ca Accessed February 9, 2009.
Topic: Clinical Trial
Prospective Evaluation of Elective Tube Exchange in Patients Requiring Prolonged Mechanical Ventilation (PREVENT): Pilot Study.
Assiri Amer1; McKechnie Kyle2; Muscedere John3
1Intensive Care Unit, Aseer Central Hospital, Abha, Saudi Arabia; 2Critical Care, Northern Ontario School of Medicine, Sudbury, ON, Canada; 3Critical Care Medicine Dep., Queen's university, Kingston, ON, Canada
Abstract:
PURPOSE:
Endotracheal tubes (ETT) with subglottic suctioning drainage (SSD) in mechanically ventilated patients have been demonstrated to reduce Ventilator Associated Pneumonia and may improve clinical outcomes. The best management strategy is unknown for patients admitted with standard ETTs who require ongoing mechanical ventilation. One strategy may be to electively replace the ETT but the benefits of reduced VAP risk must be balanced by the risk of tube exchange. A randomized controlled trial (RCT) would be required to evaluate the risks and benefits. In preparation, we conducted a pilot study whose primary objective was to determine the safety and feasibility of ETT exchange in patients presenting with a standard ETT to one with SSD.
METHODS:
We included adult patients (> 18 years) with standard ETTs intubated <36 hours with expected ongoing tracheal intubation for >72 hours. After consent, ETT exchange was done by an ICU attending/fellow using an exchange catheter. Sedation and paralysis were as per the procedural physician. Data were collected pre, during, and post procedure. Follow up was till ICU discharge or death
RESULTS:
We enrolled 20 patients, Characteristics were [mean (SD)]: age 64.5 years (11.4), APACHE II 29.1 (8.4), 17 were medical. At tube exchange, FiO2 was 0.37 (0.10), PEEP was 8.4 cm H2O (2.9). ICU length of stay was 19.1 days (17.25). ICU mortality was 30%, no deaths were related to ETT exchange. Only 1 complication, in 1 patient, was observed; a transient drop in oxygen saturation during the procedure. The study was stopped early due to lack of recruitment when institutional adoption of ETTs with SSD became the norm.
CONCLUSIONS:
In this pilot study, elective ETT change was safe and feasible. A RCT on larger scale may be feasible in centers who have not adopted ETTs with SSD although further study may not be necessary if their adoption becomes the norm.
References:
Muscedere J., Day A., Heyland D.K. Mortality, attributable mortality and time to clinical event analysis as endpoints for trials of Ventilator Associated Pneumonia and Hospital Acquired Pneumonia. Clinical Infectious Diseases. 51 Suppl 1:S120-5, 2010.
Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Critical Care Medicine. 2005;33:2184-93.
Kuti E., Patel A., Coleman C. Impact of inappropriate antibiotic therapy on mortality in patients with ventilator-associated pneumonia and blood stream infection: A meta-analysis. J of Crit Care. 2008; 23: 91–100.
Muscedere JG, Martin CM, Heyland DK. The impact of ventilator associated pneumonia on the Canadian health care system. J Crit Care.2008; 23:5-10.
Bergmans D, Bonten M, Gaillard C, Van Tiel A, Van der Geest S, De Leeuw P, Stobberingh E. Indications for antibiotic use in ICU patients: A one-year prospective surveillance. Journal of Antimicrobial Chemotherapy. 1997; 39: 527-535.
Edwards J, Peterson K, Mu Y, et al. National Healthcare Safety Network (NHSN) report: Data summary for 2006 through 2008, issued December 2009. Am J Infect Control 2009; 37: 783-805.
Morrow L, Malesker M, Farrington K. Diagnostic criteria and Intensity of surveillance affect reportable ventilator associated pneumonia rates. Chest 2006; 130 (4) Supplement: 101S
Drees M., Hausman S., Rogers A., Freeman L., Wroten K. Underestimating the impact of ventilator-associated pneumonia by use of surveillance data. Infection Control and Hospital Epidemiology. 2010; 31: 650-652.
John Muscedere, Tasmin Sinuff Co-Principal Investigators. Active OBservational Study of the Adoption and Transfer of Clinical Practice Guidelines through Education, for Ventilator Associated Pneumonia (ABATE VAP Study).
Van Saene H., Peric M., De La Cal M., Silvestri L.: Pneumonia during Mechanical Ventilation. Anestiologie a Intenzivni Medicina 2004; 15: 89-100.
Chastre J. Fagon J. Ventilator-Associated Pneumonia. Am. J. of Respir Crit Care Med. 2002; 165: 867- 903.
du Moulin GC, Paterson DG, Hedley-Whyte J, Lisbon A. Aspiration of gastric bacteria in antacid-treated patients: a frequent cause of postoperative colonisation of the airway. Lancet 1982;1:242–245
Young PJ, Ridley SA. Ventilator-associated pneumonia. Diagnosis, pathogenesis and prevention. Anaesthesia 1999;54(12):1183-97.
Heyland DK, Mandell LA. Gastric colonization and Nosocomial Pneumonia: Evidence for causation. Chest 1992;101:187-93.
Heyland DK, Wood G, Cook DJ for the Canadian Critical Care Trials Group. Is the stomach an important source of tracheal contamination and subsequent pneumonia? Clinical Intensive Care 2001;12(1):29-36.
Inglis TJ, Millar MR, Jones JG, Robinson DA. Tracheal tube biofilm as a source of bacterial colonization of the lung. J Clin Microbiol 1989;27:2014–2018
Adair CG, Gorman SP, Feron BM, Byers LM, Jones DS, Goldsmith CE, Moore JE, Kerr JR, Curran MD, Hogg G, et al. Implications of endotracheal tube biofilm for ventilator-associated pneumonia. Intensive Care Med 1999;25:1072–1076
Dullenkopf A, Gerber A, Weiss M. Fluid leakage past tracheal tube cuffs: evaluation of the new Microcuff endotracheal tube. Intensive Care Med 2003; 29: 1849–1853.
Greene R, Thompson S, Jantsch HS, et al: Detection of pooled secretions above endotracheal-tube cuffs: value of plain radiographs in sheep cadavers and patients. Am J Roentgenol 1994; 163: 1333-7.
Mahul P, Auboyer C, Jospe R, et al: Prevention of nosocomial pneumonia in intubated patients: respective role of mechanical subglottic secretions drainage and stress ulcer prophylaxis. Intensive Care Med 1992;18: 20-5.
Dezfulian, C, Shojania K, et al: Subglottic secretion drainage for preventing ventilator-associated pneumonia: a meta-analysis. Am J Med 2005; 118: 11-8.
Muscedere J., O. Rewa, K. MaKechnie, D. Laporta, X. Jiang. Heyland D.K. Sub-Glottic Secretion for the prevention of ventilator associated pneumonia; A systematic review and meta-analysis. Critical Care Medicine, 2011; 39(8): xxx
Krein SL, Kowalski CP, Damschroder L, et al: Preventing ventilator-associated pneumonia in the United States: a multicenter mixed-methods study. Infect Control Hosp Epidemiol 2008; 29: 933-40.
Anonymous, www.ihi.org/IHI/Topics/CriticalCare/IntensiveCare/Changes/ImplementtheVentilatorBundle.htm, Accessed September 2010.
Berra, L et al. Evaluation of continuous aspiration of subglottic secretion in an in vivo study. Crit Care Med 2004; 32 (10): 2071-78.
Petering HG. Pharmacology and toxicology of heavy metals: Silver. Pharmacol Ther 1976; 1: 127-130.
Gabriel M, Sawant A, Simmons R, Ahearn D. Effects of silver on adherence of bacteria to urinary catheters: in vitro studies. Curr Microbiol 1995; 30: 17-22.
Rello, J., B. Afessa, et al. Activity of a silver-coated endotracheal tube in preclinical models of ventilator-associated pneumonia and a study after extubation. Crit Care Med 2010; 38: 1135-40.
Rello J, Kollef M, Diaz E et al. Reduced Burden of bacterial airway colonization with a novel silver-coated endotracheal tube in a randomized multiple center feasibility study. Crit Care Med 2006; 34: 2766-2722.
Kollef MH, Afessa B, Anzueto A et al and the NASCENT Investigation Group. Silver-coated endotracheal tubes and incidence of ventilator-associated pneumonia: the NASCENT randomized trial. JAMA 2008; 300: 805-13.
Morrow L, Jarrett J, Malesker M et al. Systematic Use of a Silver-Coated Endotracheal Tube Reduces Rates of Ventilator Associated Pneumonia. ATS 2009.
Torres A, Gatell J, Aznar E et al. Re-intubation increases the risk of nosocomial pneumonia in patients needing mechanical ventilation Am. J. Respir. Crit. Care Med., 1995; 152: 137-141.
Muscedere J, Dodek P., Keenan S., Fowler R., Cook D., Heyland D. for the VAP Guidelines Committee and the Canadian Critical Care Trials Group. Comprehensive Evidence-Based Clinical Practice Guidelines for Ventilator Associated Pneumonia: Prevention. J of Critical Care, 2008; 23: 126-137
Heyland D., Dodek P., Day A. Muscedere J., Cook D. for the Canadian Critical Care Trials Group. A Randomized Trial Of Diagnostic Techniques For Suspected Ventilator-Associated Pneumonia. New Eng J of Medicine, N Engl J Med 2006;355:2619-30.
Heyland, DK, Dodek P, Muscedere J, Cook D. for the Canadian Critical Care Trials Group.: A randomized trial of combination versus monotherapy for the empiric treatment of suspected ventilator-associated pneumonia. Crit Care Med,.DOI: 10.1097/01.CCM.0B013E31816203D6
Muscedere J, Dodek P., Keenan S., Fowler R., Cook D., Heyland D. for the VAP Guidelines Committee and the Canadian Critical Care Trials Group. Comprehensive Evidence-Based Clinical Practice Guidelines for Ventilator Associated Pneumonia: Diagnosis and Treatment. J of Critical Care, 2008; 23: 138-147.
ABATE VAP Trial, Funded by Canadian Institutes of Health Research, Principal Investigators: Dr. John Muscedere and Tasmin Sinuff
Van An Teijlingen E., Hundley V. The importance of pilot studies. Nursing Standard 2002; 16: 33-36.
Arnold D., Burns K., Adhikari N., Kho M., Meade M., Cook D. et al. The design and interpretation of pilot trials in clinical research in critical care. Critical Care Medicine 2009; 37(Suppl.):S69-74.
Canadian Institutes of Health Research. Available at: www.cihr.ca Accessed February 9, 2009.