Condition category
Surgery
Date applied
29/01/2010
Date assigned
16/03/2010
Last edited
03/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michelle MacDougall

ORCID ID

Contact details

1 Werneth Close
Preston
PR19TS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised, controlled, open label, prospective, single centre study to investigate the use of the ENK device when compared to the standard syringe administration of 2% lignocaine solution when performing diagnostic flexible bronchoscopy

Acronym

Study hypothesis

There is no difference in efficacy of local anaesthetic administration between standard "spray as you go" technique or the use of the ENK device during flexible bronchoscopy.

Ethics approval

Preston, Chorley and South Ribble Local Research Ethics Committee approved on the 22nd March 2004 (ref: 2003.10.ix)

Study design

Randomised controlled open label prospective single centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Local anaesthetic delivery in bronchoscopy

Intervention

Administration of local anaesthetic via either the standard "spray as you go" technique or nebulised through the bronchoscope via the ENK device (which has been used to assist in awake intubations previously. The same local anaesthesic agent is used for all participants with the volume used titrated according to the clinician's assessment of requirement. All patients complete a questionnaire greater than 24 hours following the procedure (and return it in a pre-addressed and stamped envelope). No additional follow up is required.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Visual analoque scale assessments by doctor, nurse and patient regarding ease of procedure, extent of coughing and patient tolerance. Doctor and nurse questionnaires completed immediately following the procedure. Patient questionnaires completed more than 24 hours later (to ensure there is no lasting effect of any sedative medication used).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/05/2004

Overall trial end date

27/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients (either sex) attending Royal Preston Hospital for diagnostic flexible bronchoscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

Patients undergoing interventional procedures (e.g. tracheobronchial stenting, transbronchial biopsy or intrluminal palliative therapies)

Recruitment start date

05/05/2004

Recruitment end date

27/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

1 Werneth Close
Preston
PR19TS
United Kingdom

Sponsor information

Organisation

Lancashire Teaching Hospitals NHS Trust (UK)

Sponsor details

Sharoe Green Lane
Preston
PR29HT
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.lancsteachinghospitals.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Lancashire Teaching Hospitals NHS Trust (UK) - Research and Development Directorate (ref: JDM/MJ)

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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/23169083

Publication citations

  1. Results

    MacDougall M, Mohan A, Mills J, Munavvar M, Randomized comparison of 2 different methods of intrabronchial lidocaine delivery during flexible bronchoscopy: a pilot study., J Bronchology Interv Pulmonol, 2011, 18, 2, 144-148, doi: 10.1097/LBR.0b013e318216da26.

Additional files

Editorial Notes