Contact information
Type
Scientific
Primary contact
Mrs Helen Munday
ORCID ID
Contact details
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
+44 01480 830541
Helen.Munday@papworth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0542172083
Study information
Scientific title
Acronym
Study hypothesis
Within many hospitals the procedure of talc slurry instillation to induce pleurodesis (talc pleurodesis) is traditionally undertaken by physicians. Anecdotal evidence suggests that this is not a uniform approach and in some hospitals, the procedure is performed by nurses. It is suggested that appropriately trained nurses could competently perform this procedure to the benefit of their patients.
The purpose of this study is to compare outcomes when the procedure is performed by medical staff and nursing staff, notably pain and anxiety, infection and increasing oxygen requirement.
Ethics approval
Not provided at time of registration
Study design
Multi-centre, randomised pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Respiratory: Talc pleurodesis
Intervention
This is a multi-centre, randomised pilot study. Although this is a pilot study, it is recommended that individuals will be randomly allocated to prevent bias. They will be randomised to have the procedure performed either by a senior band nurse (F grade / Level 6 and above) or by a doctor. Following Local Research Ethics Committee approval, all patients meeting the study inclusion criteria will be invited to take part. Patients will be stratified according to Eastern Cooperative Oncology Group (ECOG) Performance Status to balance randomisation, so that each group is representative of the population being studied. The procedure protocol is well established and will be adhered to in both groups. Institutional limitations dictate that randomisation will be done using sealed envelopes, rather than computer generated. This will be done independently by the MRC statistician within the Research & Development Department at Papworth Hospital. Investigators will be required to telephone the department to obtain the randomisation group and study number, once the patient has signed the informed consent.
This study will compare outcomes when the procedure of talc pleurodesis is performed by a core group of senior nursing staff, compared to medical staff. The same procedure protocol will be adhered to by both groups. Both doctors and nurses will be taught how to perform the procedure by a Consultant in Chest Medicine, or a Senior Specialist Registrar identified by the Consultant as someone who is skilled and competent in performing talc pleurodesis. An educational package has been designed by the chief investigator, in collaboration with Consultant medical staff, to assist the individuals performing the procedure with self-directed learning. Evidence will be required to demonstrate their understanding of the indications and contra-indications for talc pleurodesis, as well as recognition of complications post-procedure and actions required.
The assessment of the most suitable time to perform the procedure, with regard to drainage of effusion and radiographic appearance will be decided by the medical team responsible for the care of the patient. This decision will NOT be made by the nursing staff. Prescribing of the talc will also be the responsibility of the medical staff.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Complications defined as pain, infection, increasing oxygen requirement
2. Pain and anxiety will be assessed using a Numerical Rating Scale
3. Infection will be measured according to positive culture and antibiotic therapy
4. Pulse oximetry will be measured prior to the procedure and at six hourly intervals following the procedure, in accordance with local practice. A drop in oxygen saturation below 90% will be supplemented with oxygen therapy as prescribed by the doctor.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
07/02/2006
Overall trial end date
31/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
07/02/2006
Recruitment end date
31/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Papworth Everard
Cambridge
CB3 8RE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Cambridge Consortium - Papworth Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2007 results in: Munday H, Rintoul R, Laroche C, Buttery R, Hunter C, Lau-Walker M. Talc pleurodesis: doctor versus nurse led procedure - a prospective, randomised, multi-centre, pilot study. LUNG CANCER 2007; 57:S16-S16.