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Background

Background. Commissioned call NIHR HTA Objective: To determine if invasive ventilation using protocolised weaning that includes non-invasive ventilation (NIV) as an intermediate step is clinically and cost effective compared to protocolised weaning without NIV. Study summary.

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Background

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  1. Background • Commissioned call NIHR HTA • Objective: To determine if invasive ventilation using protocolised weaning that includes non-invasive ventilation (NIV) as an intermediate step is clinically and cost effective compared to protocolised weaning without NIV

  2. Study summary • Design: Pragmatic, open label, RCT • Population: Adults, ventilated > 48 hr, fail SBT • Intervention: Weaning using NIV • Comparator: Protocolised invasive weaning • Outcome: Time to liberation from ventilation • Sample size: 920 over 30 months

  3. Study Timeline

  4. Recruitment Plan Target for sites 1.5 patients per month

  5. Outcomes Primary clinical outcome: Time from randomisation to liberation from ventilation

  6. Secondary clinical outcomes • 30, 90 and 180 day all cause mortality • Duration of invasive mechanical ventilation and total ventilator days • Time to meeting ICU discharge criteria • Hospital length of stay • Antibiotic use • Re-intubation, tracheostomy; adverse events • Health related quality of life

  7. Inclusion criteria • Is the patient age 16 years or older? • Has the patient received invasive mechanical ventilation for respiratory failure for greater than 48 hours? • Is the patient ready for weaning?

  8. Exclusion criteria • Patient known to be pregnant • Presence of tracheostomy • Profound neurological deficit • Any absolute contraindication to NIV • Home ventilation prior to ICU admission • Decision not to re-intubate / withdrawal • Further surgery / procedure requiring sedation planned in next 48 hours • Previous participation in the Breathe study

  9. Daily Screening All ventilated patients will be assessed each morning for eligibility by ICU nursing / medical staff. Patients will be identified as potentially eligible if they fulfil the following criteria: • anticipated or actual requirement for invasive ventilation for > 24 hours • at least partial reversal of the condition precipitating invasive ventilation • stabilisation of "other" organ system failures (i.e. no worsening) • arterial oxygen saturation measured using pulse oximetry (SpO2) ≥ 90% with fractional concentration inspired oxygen (FiO2) ≤ 0.70 • PEEP ≤ 10 cmH2O • the absence of trial exclusion criteria (above) A screening log will be maintained at each site which will include the reasons for non-enrolment.

  10. Daily screening for eligibility and assess for readiness to wean Obtain consent Record baseline characteristics PASS Spontaneous Breathing Trial Excluded FAIL RANDOMISE Protocolised NIV weaning arm Protocolised Invasive weaning arm

  11. CONSENT PROCESS * England, Wales, NI

  12. Readiness to wean • Cooperative and pain free • Good cough • PaO2: FiO2 ratio >24 kPa • PEEP <10 cmH2O • Hb>7 g dL-1 • Temperature 36 - 38.5°C • Vasoactive drugs stable • Spontrespiratory rate >6 min-1 Walsh BJA 2004

  13. Record baseline characteristics • Exhaled minute volume • Total respiratory rate • PEEP • Plateau pressure • Heart rate • Systolic blood pressure • Arterial blood gases

  14. SBTTo be performed in accordance with local unit practices 30 mins duration • T-piece • Psupp5cm H2O • CPAP Pass – Extubate Fail - Randomise Ely N Engl J Med 1996

  15. Standardised protocols • Ventilator care bundle • head up position; oral decontamination; sedation hold; peptic ulcer prophylaxis • Tracheostomy • More than 7 days IMV; inability to protect airway; persistent inability to remove respiratory secretions • Re-intubation • Protocolised and clinical endpoints

  16. Data collection

  17. Baseline variables • Patient identifiers • Inclusion and exclusion criteria • APACHE II (at admission) • Admission diagnosis • Presence of COPD • Height and weight • Duration of ventilation prior to randomisation • CAM-ICU

  18. Daily data Adverse events Sedation usage Weaning and ventilator bundle compliance • Ventilation status (IMV, NIV, self-ventilating) • Organ support requirements • Level of critical care • Antibiotic use for respiratory and non-respiratory infection

  19. Study endpoints Discontinuation of intervention NIV arm – re-intubation IPPV arm – tracheostomy Withdrawal of consent Need to continue data collection after discontinuation of intervention until ICU / hospital discharge Endpoints • Liberation from ventilation • Add definition from CRF • Death • Tracheostomy • Re-intubation • Actual • Protocolised • ICU discharge data

  20. After discharge Before hospital discharge (on site) After hospital discharge (WCTU) Survival to 180 days EQ-5D and SF-12 Healthcare resource use questionnaire • Consent • Antibiotic use if started within ICU • Acute hospital discharge date and status • HRQoL

  21. Serious Adverse Events A serious adverse event is an AE that fulfils one or more of the following criteria: • Results in death • Is immediately life-threatening • Requires hospitalisation or prolongation of existing hospitalisation • Results in persistent or significant disability or incapacity • Is a congenital abnormality or birth defect • Is an important medical condition. The causality of SAEs (i.e. relationship to trial treatment) will be assessed by the investigator(s) and recorded on the SAE form. **Do not report death, pneumonia, organ failure as SAE**

  22. Safety Reporting All suspected SAE’s report to Warwick Clinical Trials Unit within 24 hours (Tel: 02476 575849 Fax: 02476 150549)

  23. Patient Follow-up Health-related quality of life: EQ-5D, SF12 at baseline (estimated) Patient follow-up: 3 and 6 months EQ-5D and SF12

  24. Study team Chief Investigator: Prof Gavin Perkins Project Manager: Sarah Duggan Trial Coordinator: Bev Hoddell Trainee Trial Coordinator: Jess Smith Research Facilitator: Laura Blair Research Nurse: Vikki Gordon

  25. Pilot Study Sites Hospital PI Research Nurse HEFT – Heartlands Prof Fang Gao-Smith Peter Sutton UHCW Chris Bassford Marie McCauley Guys & St Thomas’ Nick Hart & Luigi Camporota Katie Lei/John Smith QEHB Catherine Snelson Arlo Whitehouse Bristol RI Tim Gould & Sanjoy Shah Katie Sweet RVH Belfast Danny McAuley JR Oxford Duncan Young

  26. Questions?Contact: Bev Hoddell, Trial Coordinator. Tel No: 02476-575849 Email:b.hoddell@warwick.ac.ukAddress: Warwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, CoventryCV4 7AL

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