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Collaborators’ meeting October 2004

Collaborators’ meeting October 2004. The importance of the CESAR trial - Giles Peek Recruitment and enquiries – Ann Truesdale Ingredients for success – Luton & Dunstable, Bedford Clinical concerns - Ravin Tiruvoipati Economics alongside CESAR - Miranda Mugford

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Collaborators’ meeting October 2004

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  1. Collaborators’ meeting October 2004 • The importance of the CESAR trial - Giles Peek • Recruitment and enquiries – Ann Truesdale • Ingredients for success – Luton & Dunstable, Bedford • Clinical concerns - Ravin Tiruvoipati • Economics alongside CESAR - Miranda Mugford • Follow-up of patients in trial - Andy Wilson • Keynote speaker: Evidence based care in ICUs - David Goldhill

  2. The Importance of the CESAR Trial Giles J Peek MD FRCS (CTh) Lead Clinical Investigator

  3. What is the Population ? • Adults (18-65 years) • Severe, but potentially reversible respiratory failure • Murray score >3.0, • or • Uncompensated hypercapnoea with a pH <7.20

  4. Expected Survival • Intensive Care National Audit & Research Centre (ICNARC) • The mortality of the 1,506 patients with a PaO2/FIO2 ratio of 100 mmHg in this database was 61.6%

  5. Outcomes for population of patients being studied in CESAR • Vasilyev 1995 • Morris et al 1994 • Peek et al 1997 • Pettifer et al 2001

  6. Vasilyev; Chest 1995;107:1083-8 • 1426 patients in 25 university hospitals • 1991-1992 • Entry criteria: FIO2>50% >24 hours. • Overall hospital survival: 55.6%

  7. Vasilyev; Chest 1995;107:1083-8. • Severe Lung Injury: Murray > 2.5 Survival=30% • End Stage Lung Injury: Murray > 3.5 Survival=18.4% • FIO2 > 80%, Survival <20%

  8. Morris et al,Am J Respir Crit Care Med 1994;149:295-305. • Randomised trial of PCIRV vs ECCO2R • 19 PCIRV patients • 8 survived • Hospital survival = 42%

  9. Extracorporeal Membrane Oxygenation for Adult Respiratory Failure Chest 1997;112:759-764. Peek GJ, Moore HM, Moore N, Sosnowski AW & Firmin RK

  10. Adult ECMO,AIMS & DESIGN. • Retrospective chart review of first 50 adult patients to receive ECMO for acute severe respiratory failure at Groby Road / Glenfield • Primary end point: hospital survival

  11. Adult ECMO,INDICATIONS. • Potentially reversible respiratory failure refractory to maximal conventional treatment • Ventilated < 7 days • No contra-indication to heparin

  12. PaO2/FIO2 65mmhg Murray Score=3.4 Time Vent=76.5 hrs Time on 100% O2= 14 hrs. PAP = 39.6 cmH2O. PEEP = 10 cmH2O. MV = 12.6 L/min. MAP = 82 mmHg. MPAP = 29 mmHg. CVP = 12 mmHg. PAWP = 12 mmHg. CO = 127 ml/kg/min. UO = 1.4 ml/kg/hr. Age = 30.1 yrs. Wt = 71.9 Kg. Hb = 10.8 Kg. PATIENT STATUS AT REFERRAL.

  13. SURVIVAL BY DIAGNOSIS

  14. OUTCOME IN ADULTS WHEN ECMO IS UNAVAILABLE Pettifer R J*, Peek G J, Sowsnowski A, Killer H & Firmin R K. Heartlink ECMO Unit, Glenfield Hospital, Leicester, UK.

  15. Results • Conventional patients 8/28 Survived (28.5%) • ECMO patients 39/57 Survived (68.4%) • p=0.001

  16. Effect of prone positioning on the survival of patients with acute respiratory failure Gattinoni L. et al. NEJM 2001;345(8):568-573

  17. Gattinoni L. et al: patients • 304 patients, 152 in each group. • Age: 57 supine, 59 prone • PaO2/FIO2: 122 supine, 117 prone • number of non-pulmonary failed organs: • 1.4 supine, 1.3 prone

  18. Gattinoni L. et al: outcomes • Mortality • 23 % at 10-days, 49.3 % at discharge from ICU, 60.5% at 6 months • Relative risk of death prone vs supine 1.06 at six months (0.88 to 1.28) • Mean increase in PaO2/FIO2 prone vs. supine group (63.0+/-66.8 vs. 44.6+/-68.2, P=0.02). • CONCLUSIONS: Although placing patients with acute respiratory failure in a prone position improves their oxygenation, it does not improve survival

  19. Ventilation with lower tidal volumes for acute lung injury and the acute respiratory distress syndrome The Acute Respiratory Distress Syndrome Network N Engl J Med 2000;342:1301-8

  20. Lower tidal volumes: patients • 6ml/Kg (PIP<30) vs. 12ml/Kg (PIP<50) • 861 patients • Age 51 + 17 vs. 52 + 18 • PaO2/FIO2 138 + 64 vs. 134 + 58

  21. Lower tidal volumes: results • TV 6.2 + 0.8 vs. 11.8 + 0.8 ml/kg • PIP 25 + 6 vs. 33 + 8 cm/H2O • Mortality 31.0% vs. 39.8% (p=0.007) • Days without organ failure also lower (p=0.006)

  22. Conclusions • CESAR trial population at high risk of death • Good evidence that lower tidal volume effective strategy in conventional ventilation • Effect of ECMO compared to conventional ventilation not yet known

  23. 5.7 patients per month !

  24. Recruitment and enquiries Ann Truesdale, CESAR Trial Advisor

  25. Patient recruitment July 2001-Sep 2004

  26. Recruitment • End September 2004 107 • Target 30th November 2005 180

  27. Recruitment and enquiries July 2001-Sep 2004

  28. 90 centres online 47 have recruited (excluding EIPs) Best recruiting centres Luton and Dunstable (7) Castle Hill (6) Gloucester Royal (6) Queen Elizabeth Gateshead (6) Glenfield ICU (5) Leicester Royal (4) Participating centres (1)

  29. 116 centres made enquires Best enquiry centres Bedford (17) Queen Elizabeth Gateshead (14) Luton and Dunstable (12) Royal Bolton (12) University Hospital North Staffs (10) Gloucester Royal (9) Hull (9) Participating centres (2)

  30. CESAR Collaborators • Visibility • Trials • Presentations/Profile • Nurses • Working Pattern (Early)

  31. Bedford Hospital CCC – CESAR recruitment • Publicity • Notice board in staff restroom • Posters on pillars • CESAR sticky ads at patient desks & telephones • CCIMS • Murray score on record entitled “CESAR” • Feedback • Following study days • Nurse leads • 3: so nearly always 1 on duty • Good links with CESAR

  32. Clinical Concerns Ravin Tiruvoipati Clinical Research Fellow-CESAR trial

  33. Role of Clinical Research Fellow. • Key link between participating centres and trial coordination group. • Encourage centres to participate in trial • Address any clinical queries • Co-ordinate between the CAT team and data co-ordination team and the teams from referring hospitals

  34. CESAR Research Fellows

  35. Concerns • Participating centres • CAT Team • Data coordination group

  36. Concerns (of some centres) • Transport issues • Dedicated transport team • Road/Air transfer • Poster presented in the ICS meet at Torquay(May 2004.) • Moving patients from EIP centres.(from the referring hospital and accepting CTCs )

  37. Equipment / Monitoring in transfer • Ventilator (gas driven) • Defibrillator • Suction apparatus • Non invasive (ECG,HR,Saturations,End tidal CO2) • iNO • Invasive monitoring BP • Blood glucose (and ABGs soon).

  38. (Non) Availability of bed for ECMO • increased ECMO beds at Glenfield • Awareness of Trial • Post cards, news letters, visits, chocolates, stickers,mugs, pens, posters, calculators, mints, CESAR Stands in the ICS conferences, study days for the nurses in participating centres

  39. Inclusion/Exclusion criteria. • FiO2 > 80%, PIP > 30, pH < 7.2 • Multiorgan failure.

  40. Concerns (CAT team) • Late referrals • Ventilated for more than 10 days. • Ventilated with high pressure and/or high FiO2 for more than 7 days. • Inadequate data during referral. • Failed organs • Prone ventilation • Ionotropic supports.

  41. Concerns (Data co-ordination centre) • Completion of Registration forms (Form A and B). • Completed Assent Form • Data collection on the organ support sheet.

  42. Any further concerns ? - I’ll be back!

  43. We look forward to at least one patient from your centre in the next year.

  44. Economics and the CESAR trial • Purpose and aims • Comparing costs and benefits • Benefits of ECMO • Costs for the health service • Costs for patients and their supporters • Contribution of trial centres to the economic analysis

  45. Economics and the CESAR trial – economics researchers • CESAR PMG members with • University of East Anglia • Miranda Mugford • Mariamma Thalanany • University of Sheffield • Clare Hibbert • Lizzie Coates – to Sep 04

  46. CESAR economic evaluation Purpose and aims • Health technology • assessment and NHS decision makers • Need to show that new forms of care are • effective • are worth funding

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