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%%75The Positive Pressure in Pulmonary Oedema (3PO) Study66?S.D. Crane, A.J. Gray, M. Elliott, P. Gilligan and K. Richards..@ 5The Research QuestionDoes the use of non-invasive ventilation (either Bilevel or CPAP) in patients with acute, acidotic, cardiogenic pulmonary oedema (CPO) result in better clinical outcomes than the use of standard oxygen therapy alone?Methodology (1)$Setting The A&E departments of St. James s University Hospital and the General Infirmary in Leeds. Design An unblinded, randomised controlled trial of continuous positive airways pressure (CPAP), bilevel ventilation or standard face mask oxygen in the treatment of CPO. Ethics Approval was obtained from the local research ethics committee Statistics SPSS 9 for Windows ANOVA and Chi-squared used as appropriate Randomisation Computer generated random numbers (Microsoft Excel) Concealment of allocation Treatment allocation and data collection forms folded inside sealed opaque A5 envelopes, which in turn inside sealed, opaque A4 envelopes6Z[ZZZZ@Z Z>ZZ4ZZZ[@   >  4Methodology (2)Patients (Included) 60 patients (20 per arm) Adults presenting to the resuscitation rooms with dyspnoea and clinical signs of CPO. Respiratory rate > 23 breaths per minute. Arterial blood pH of < 7.35. CXR appearance consistent with CPO. D Patients (Excluded) Needed immediate thrombolysis Needed acute dialysis Temperature 38oC or higher Patients scoring P or U on the AVPU scale Patients with systolic BP of 90 mmHg or less Patients requiring acute cardioversion or pacing for causative arrhythmia rZZ C Methodology (3)$uTrial process Potentially eligible patient arrived in resuscitation room Doctor / nurse telephoned researcher (SC, PG or KR) who attended A&E Patient received standard therapies as directed by treating doctor whilst waiting for researcher to arrive Pre-trial data recorded on data collection form Consent Informed, written consent was obtained from the patient where possible. If the patient was unable to consent for themselves, relatives provided informed, written assent for their relative to participate in the study. Unaccompanied patients who were unable to provide consent for themselves were withdrawn from the study. ZZZBZZZB Methodology (4)$Interventions All patients received oxygen, frusemide, nitrates or opiates as directed by the treating doctors without restriction on dosage or route of administration. The control group received standard face mask oxygen The CPAP group received continuous airways pressure at 10 cm H2O The bilevel group received inspiratory pressure at 15 cm H2O and expiratory pressure at 5 cm H2O (i.e. 10 cm H2O pressure support) The ResMed VPAP II ventilator was used.  = #  = Methodology (5)$yData collected during 2 hr study period Physiological parameters every 10 minutes (pulse, BP, RR, oxygen saturation). Total urine output. Arterial blood gas analyses at time zero, at 1 hr and at 2 hrs. A 100 mm breathlessness scale at time 0, 30 mins, 1 hr, 90 mins and 2 hrs. Incidence of complications (vomiting, facial injury) Outcome measures Treatment success rate (defined as reversal of acidosis (pH > 7.35), oxygen saturation of 90% or more and respiratory rate <22 breaths per minute) at 2 hrs. Intubation rate. Myocardial infarction rate (based on WHO criteria) within three days of presentation. In-hospital mortality. (Z#ZZZZZZ(#:),Comparison of Included and Excluded Patients--Included (n=60) Mean(SD) age(yrs) 75.1 (10.5) % male sex 38.3 Mean (SD) arrival pulse (bpm) 111 (21) RR (bpm) 35 (7) SBP (mmHg) 166 (39) DBP (mmHg) 92 (21) SpO2 (%) 91 (8) Mean (SD) arrival pH 7.197 (0.09) pO2 (kPA) 13.23 (7.42) pCO2 (kPA) 8.22 (2.47) SaO2 (%) 89.9 (10.4) ZZ ZZZZ\ZZTZZ    O         Excluded (n=176) Mean (SD) age(yrs) 78.3 (9.2) % male sex 36.9 Mean (SD) arrival pulse (bpm) 112 (23) RR (bpm) 32 (6) SBP (mmHg) 165 (36) DBP (mmHg) 87 (22) SpO2 (%) 92 (7) Mean (SD) arrival pH 7.221 (0.09) pO2 (kPA) 13.07 (7.08) pCO2 (kPA) 8.07 (2.57) SaO2 (%) 91.8 (7.4) ZZ Z ZZZ]ZZSZZZ      P         0Comparison of Included and Excluded Patients (1) 10MIncluded (n=60) % PMHx of CCF 40 IHD 53 COPD 27 DM 25 Hypertension 37 X 1 1  7 KExcluded (n=176) % PMHx of CCF 28 IHD 44 COPD 22 DM 26 Hypertension 18 V 0 0  56Comparison of the three treatment arms at baseline (1)776Comparison of the three treatment arms at baseline (2)"767'GComparison of other treatments given in A&E to the three treatment arms"HG*!,#.%/&+"-$(Treatment Success at 2 hours Three arm comparisons Control 3/20 (15%) CPAP 7/20 (35%) Bilevel 9/20 (45%) Chi square significance p=0.116 Two way comparisons Bilevel v control OR = 4.64 (95% CI 1.02  21.0) Chi squared significance p=0.038 CPAP v control OR = 3.05 (95% CI 0.66  14.14) Chi squared significance p=0.144 Bilevel v CPAP OR = 1.52 (95% CI 0.43  5.43) Chi squared significance p=0.519  6 1"/"."6   1"/"."  $$) Survival to discharge tThree way comparison Control 14/20 (70%) CPAP 20/20 (100%) Bilevel 15/20 (75%) Chi squared significance p=0.032 Two way comparisons Bilevel v control OR = 1.29 (95% CI 0.32  5.18) Chi squared significance p=0.723 CPAP v control Fishers test significance p=0.020 CPAP v bilevel Fishers test significance p=0.047 *Z:Z!ZZ1Z!ZZ#ZZ"ZZ:!    1!#"!FComparison of other main outcome measures for the three treatment armsGG8(-Mean total urine output over 2hr study period.. JControl 443 mls CPAP 359 mls Bilevel 415 mls ANOVA significance p= 0.602>   ' Complication Rates of Treatments!! fFacial injury Control 0/20 CPAP 1/20 Bilevel 1/20 Vomiting Control 2/20 CPAP 1/20 Bilevel 0/20 \' (' (#Criticisms of this study"$Small size Low recruitment rate Unblinded researcher and patients Non-invasive monitoring used Non-standardised pharmacological treatments  $ Conclusions $4There is some evidence of improved short term physiological parameters in CPO patients treated with NIV Patients treated with CPAP were significantly more likely to survive than those in the other treatment arms A large definitive study or a meta-analysis of the current data from smaller studies is required55&   Results (1) Data collected from 1st May 2000 until 5th September 2001 A total of 542 patients with clinical signs of CPO attended the resuscitation rooms of the two departments 306 ineligible 187 not acidotic 52 not dyspnoeic (RR < 23 breaths per minute) 16 were pyrexial (temperature 38oC or above) 15 were comatose (scoring P or U on AVPU scale) 14 were hypotensive (systolic BP 90 mmHg or less) 14 received immediate thrombolysis 8 needed dialysis ZZZZ  _     Results (2) 236 patients were eligible 60 randomised 176 not randomised 102 researcher not phoned 33 unable to obtain consent 22 had improved such that they no longer fitted entry criteria 19 inconvenient for researcher Approximately 1 in 4 inclusion rate@<$<$XChanges seen in physiological parameters in the 2 hour study period for the three groups"YXTChanges seen in blood gas parameters in the 2 hour study period for the three groups"UT ` ` ̙33` 333MMM` ff3333f` f` f` 3` f̙33>?" dd@,|?" dd@   " @ ` n?" dd@   @@``PR    @ ` ` p>> c(    6d P  T Click to edit Master title style! !  0   RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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