Talc Pleurodesis: A Comparative Pilot Study Comparing Doctor vs Nurse Lead Procedure

ISRCTN	ISRCTN59686582
DOI	https://doi.org/10.1186/ISRCTN59686582
Secondary identifying numbers	N0542172083

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 27/06/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Helen Munday
Scientific

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Phone	+44 01480 830541
Email	Helen.Munday@papworth.nhs.uk

Study information

Study design	Multi-centre, randomised pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	07/02/2006
Completion date	31/08/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	07/02/2006
Date of final enrolment	31/08/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Papworth Everard

Cambridge
CB3 8RE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Cambridge Consortium - Papworth Hospital NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		01/08/2007		No	No