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ISRCTN
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ISRCTN77331907
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ClinicalTrials.gov identifier
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Public title
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A randomised comparison of two different methods of intrabronchial lignocaine delivery during flexible bronchoscopy
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Scientific title
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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
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Preston, Chorley and South Ribble Local Research Ethics Committee approved on the 22nd March 2004 (ref: 2003.10.ix)
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Study design
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Randomised controlled open label prospective single centre study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Local anaesthetic delivery in bronchoscopy
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Participants - inclusion criteria
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All adult patients (either sex) attending Royal Preston Hospital for diagnostic flexible bronchoscopy
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Participants - exclusion criteria
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Patients undergoing interventional procedures (e.g. tracheobronchial stenting, transbronchial biopsy or intrluminal palliative therapies)
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Anticipated start date
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05/05/2004
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Anticipated end date
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27/09/2006
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Lancashire Teaching Hospitals NHS Trust (UK) - Research and Development Directorate (ref: JDM/MJ)
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Trial website
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Publications
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Contact name
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Dr
Michelle
MacDougall
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Address
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1 Werneth Close
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City/town
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Preston
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Zip/Postcode
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PR19TS
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Country
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United Kingdom
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Sponsor
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Lancashire Teaching Hospitals NHS Trust (UK)
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Address
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Sharoe Green Lane
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City/town
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Preston
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Zip/Postcode
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PR29HT
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Country
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United Kingdom
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Sponsor website:
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http://www.lancsteachinghospitals.nhs.uk/
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Date applied
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29/01/2010
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Last edited
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16/03/2010
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Date ISRCTN assigned
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16/03/2010
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