Overview
CHELsea II is a cluster randomised trial comparing the treatment of encouraging/helping the patient to drink, giving the patient regular mouth care, and usual management of symptoms (Group A) versus giving fluid by a drip in addition to the care given in group A (Group B).
The CHELsea II trial is registered on the ISRCTN trial registry, registration number 65858561.
Endpoints
Primary endpoint
The primary endpoint is:
- Proportion of participants that develop delirium in each group.
Secondary endpoints
The secondary endpoints are:
- Proportion of participants that receive as required and/or regular medication for delirium
- Time to first dose of medication for delirium
- Modified Richmond Agitation and Sedation Scale (m-RASS) scores during trial. The RASS is a validated measuring tool for severity of agitation and level of sedation, and the m-RASS has been modified for/validated in patients with advanced cancer
- Proportion of participants with audible upper airway secretions
- Proportion of participants that receive as required and/or regular medication for audible upper airway secretions
- Time to first dose of medication for audible upper airway secretions
- Proportion of participants that experience pain, shortness of breath, and nausea and vomiting
- Adverse effects of CAH
- Overall survival. Participants that survive >14 days will continue to be followed up in order to determine their date of death
- Participant level costs and cost effectiveness based on reductions in the likelihood of delirium
- Carer feedback on end-of-life care and research participation. The survey will be sent out 8 weeks after the participant’s death.
