Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Helen Munday


Contact details

Papworth Everard
United Kingdom
+44 01480 830541

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet


Respiratory: Talc pleurodesis


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



Not Specified

Drug names

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 trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Not provided at time of registration

Participant type


Age group

Not Specified


Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Papworth Everard
United Kingdom

Sponsor information


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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

Cambridge Consortium - Papworth Hospital NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

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.

Publication citations

Additional files

Editorial Notes