CESAR: Conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure

Conditions

Respiratory tract diseases: Severe acute respiratory failure Respiratory Severe acute respiratory failure

Peek GJ, Elbourne D, Mugford M, Tiruvoipati R, Wilson A, Allen E, Clemens F, Firmin R, Hardy P, Hibbert C, Jones N, Killer H, Thalanany M, Truesdale A.

2010-07-01113 citations

10.3310/hta14350

Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial.

Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D, CESAR trial collaboration.

2009-09-152,155 citations

10.1016/s0140-6736(09)61069-2

Methods of data collection and analysis for the economic evaluation alongside a national, multi-centre trial in the UK: conventional ventilation or ECMO for Severe Adult Respiratory Failure (CESAR).

Thalanany MM, Mugford M, Hibbert C, Cooper NJ, Truesdale A, Robinson S, Tiruvoipati R, Elbourne DR, Peek GJ, Clemens F, Hardy P, Wilson A, CESAR Trial Group.

2008-04-3014 citations

10.1186/1472-6963-8-94

Interventions

Conventional positive pressure ventilation vs. Extracorporeal Membrane Oxygenation (ECMO)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult patients (18-65 years in UK) 2. With severe, but potentially reversible respiratory failure. Severe respiratory failure will be defined as a Murray score >3.0, or uncompensated hypercapnoea with a pH <7.20

Exclusion criteria

Exclusion criteria: 1. Duration of high pressure and/or high FiO2 ventilation >7 days 2. Intra-cranial bleeding 3. Any other contra-indication to limited heparinisation 4. Patients who are moribund and have any contra-indication to continuation of active treatment

Design outcomes

Primary

Measure	Time frame
Death or severe disability at six months. Severe disability will be defined as requiring full time nursing care at home, or continued residence in hospital.	—

Secondary

Measure	Time frame
1. Hospital Indices: duration of ventilation, length of ITU stay, length of hospital stay. Daily APACHE II score. In addition, data will be collected on ventilator settings, arterial blood gases, total intake minus output excluding blood loss and replacement, weight, full nutrition, haemoglobin, white blood cell count, blood products administered, prone position, nitric oxide, creatinine, bilirubin and maximum temperature. For ECMO patients only, data will be collected on mode (VV/VA), blood flow and sweep flow. 2. Follow up: Survivors will be contacted 6 months after randomisation for a detailed domicillary by a chest physician using a structured data collection form. Patients (or their carers, if necessary) will also complete questionnaires, assessment using standard scales to assess their activities of daily living, respiratory symptoms and psychological state. Economic issues: The trial will assess the cost of treatment to the health and social services and to patients and their families in each treatment group. An incremental cost-effectiveness ratio will be calculated and compared to that for similar life-extending treatments. Information for the costs of inpatient and domicillary care will be collected using methods adapted from the neonatal ECMO Trial.	—

Measure

Time frame

1. Hospital Indices: duration of ventilation, length of ITU stay, length of hospital stay. Daily APACHE II score. In addition, data will be collected on ventilator settings, arterial blood gases, total intake minus output excluding blood loss and replacement, weight, full nutrition, haemoglobin, white blood cell count, blood products administered, prone position, nitric oxide, creatinine, bilirubin and maximum temperature. For ECMO patients only, data will be collected on mode (VV/VA), blood flow and sweep flow. 2. Follow up: Survivors will be contacted 6 months after randomisation for a detailed domicillary by a chest physician using a structured data collection form. Patients (or their carers, if necessary) will also complete questionnaires, assessment using standard scales to assess their activities of daily living, respiratory symptoms and psychological state. Economic issues: The trial will assess the cost of treatment to the health and social services and to patients and their families in each treatment group. An incremental cost-effectiveness ratio will be calculated and compared to that for similar life-extending treatments. Information for the costs of inpatient and domicillary care will be collected using methods adapted from the neonatal ECMO Trial.

—

Countries

United Kingdom

Outcome results

None listed