A randomised comparison of two different methods of intrabronchial lignocaine delivery during flexible bronchoscopy
| ISRCTN | ISRCTN77331907 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77331907 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/01/2010
- Registration date
- 16/03/2010
- Last edited
- 03/04/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michelle MacDougall
Scientific
Scientific
1 Werneth Close
Preston
PR19TS
United Kingdom
Study information
| Study design | Randomised controlled open label prospective single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Preston, Chorley and South Ribble Local Research Ethics Committee approved on the 22nd March 2004 (ref: 2003.10.ix) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 05/05/2004 |
| Completion date | 27/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | All adult patients (either sex) attending Royal Preston Hospital for diagnostic flexible bronchoscopy |
| Key exclusion criteria | Patients undergoing interventional procedures (e.g. tracheobronchial stenting, transbronchial biopsy or intrluminal palliative therapies) |
| Date of first enrolment | 05/05/2004 |
| Date of final enrolment | 27/09/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
1 Werneth Close
Preston
PR19TS
United Kingdom
PR19TS
United Kingdom
Sponsor information
Lancashire Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Sharoe Green Lane
Preston
PR29HT
England
United Kingdom
| Website | http://www.lancsteachinghospitals.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/02j7n9748 |
Funders
Funder type
Hospital/treatment centre
Lancashire Teaching Hospitals NHS Trust (UK) - Research and Development Directorate (ref: JDM/MJ)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2011 | Yes | No |
