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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/23169083
Publication citations
-
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.