Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000358842
Ethics application status
Approved
Date submitted
15/12/2015
Date registered
30/03/2021
Date last updated
30/03/2021
Date data sharing statement initially provided
30/03/2021
Date results information initially provided
30/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparison of patient assessment of comfort, comparing bronchoscopy with conscious sedation or anaesthetist controlled sedation; a randomised prospective trial.
Scientific title
Comparison of comfort scores comparing bronchoscopy with conscious sedation or anaesthetist controlled sedation; a randomised prospective trial.
Secondary ID [1] 288152 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthetic Quality during Bronchoscopy 320908 0
Condition category
Condition code
Respiratory 297290 297290 0 0
Other respiratory disorders / diseases
Anaesthesiology 297433 297433 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm are to be given Conscious Sedation by:
a) Using a combination of Fentanyl and Midazolam
b) The doses of these medications where given at the discretion of the proceduralist up to a maximum of 100ug and 5mg respectively.
c) Medications were administered intravenously.
d) Medications were given at the commencement of the procedure, and additional amounts where given, up to the maximum, at the discretion of the proceduralist to maintain adequate comfort during the procedure.
e) The required medication amount was logged within the Anaesthetic record.
Intervention code [1] 293463 0
Diagnosis / Prognosis
Intervention code [2] 293569 0
Treatment: Other
Intervention code [3] 319847 0
Treatment: Drugs
Comparator / control treatment
The control arm were given General Anaesthetic delivered by an Anaesthetist by:
a) Using an opiate medication (either fentanyl or remifentanyl) in combination with a propofol infusion.
b) Dosage of medications was individualised for the patient. The dose of the opiate medication was left to the discretion of the anaesthetist. Propofol infusion was delivered via a proprietary infusion pump and managed by the anaesthetist.
c) All medications were given intravenously.
d) Opiate medications were given at the commencement of the procedure. Propofol was infused throughout as above.
e) All dosages and infusion parameters were record in the anaaesthetic record.
Control group
Active

Outcomes
Primary outcome [1] 296869 0
Comfort score by visual analogue scale.
Timepoint [1] 296869 0
Day following procedure via telephone interview.
Primary outcome [2] 326671 0
Willingness to repeat procedure if required.
Timepoint [2] 326671 0
Day following procedure via telephone interview.
Secondary outcome [1] 319559 0
Staff resource use - this will be assessed by the procedural log. The number and period of time staff are required during the procedure and during pre and post procedural periods will be measured.
Timepoint [1] 319559 0
Staff will log time and staff numbers throughout the procedure.
Secondary outcome [2] 319560 0
Staff comfort score by visual analogue scale
Timepoint [2] 319560 0
Measured at the completion of the procedure, however, representing an overall score for the procedure.
Secondary outcome [3] 319561 0
Level of sedation as defined by BIS monitoring
Timepoint [3] 319561 0
This is a second to second score which is reported in the anaesthetic log. At the completion of the procedure we will have a BIS score vs time plot for the entirety of the procedure.
Secondary outcome [4] 319813 0
Complications during procedure or recovery period. Complications included hypotension, bronchospasm, haemoptysis (small and large volume) and cardiovascular event. These were assessed either visually with haemoptysis, or with bedside cardiorespiratory monitoring equipment, as is standard during the procedure and during the post procedure recovery phase.
Timepoint [4] 319813 0
Complication events were recorded during the procedure log and assessed following the procedure in the anaesthetic recovery room.

Eligibility
Key inclusion criteria
Patients requiring bronchoscopy for medical reason
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those <18 years of age, pregnant women, those with an artificial airway such as tracheostomy, significant allergy demanding specific anaesthetic and those unable to give accurate information regarding their experience (i.e. those lacking mental capacity).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be done by the primary investigator only and determined using sequentially numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Comparisons will be performed with the Student t test, chi-square or Fisher exact test, as appropriate,
Sample size has been determined with power calculation using a significance level 5% (alpha = 0.05) and powered to 90% (beta = 0.1). The non-inferiority limit, d, of 15% was used. This is on the basis that a previous similar study (Clark G, Licker M, Younossian AB, et al. Eur Respir J 2009; 34: 1277–1283) that was able to show significance with a non inferiority limit of 35%.
Our primary end point data will look at a continuous variable (sample size =22) as well as a binary dichotomous variable (sample size = 98).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/10/2013
Date of last participant enrolment
Anticipated
Actual
30/12/2014
Date of last data collection
Anticipated
Actual
31/07/2015
Sample size
Target
90
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4954 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 12453 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 292562 0
Hospital
Name [1] 292562 0
Royal Brisbane and Womens Hospital - Department of Thoracic Medicine
Country [1] 292562 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital - Department of Thoracic Medicine
Address
RBWH
Butterfield st
Herston
QLD
4006
Country
Australia
Secondary sponsor category [1] 291282 0
None
Name [1] 291282 0
None
Address [1] 291282 0
None
Country [1] 291282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294038 0
Royal Brisbane and Womens Hospital
Ethics committee address [1] 294038 0
Office of the Human Research Ethics Committee
Level 7 Block 7
RBWH
Herston
QLD
4006
Ethics committee country [1] 294038 0
Australia
Date submitted for ethics approval [1] 294038 0
31/07/2013
Approval date [1] 294038 0
01/10/2013
Ethics approval number [1] 294038 0
HREC/13/QRBW/145

Summary
Brief summary
As part of any bronchoscopic procedure, patients are administered sedation. This is in order to make the procedure as comfortable as possible for them, as well as making the procedure technically easier by reducing movement and suppressing cough. We currently use two methods of sedation: 1) Conscious Sedation: this is the use of 2 medications (Midazolam and Fentanyl); administered by one of the treating doctors, whilst the other doctor performs the bronchoscopy. The dose of medication is adjusted to the desired effect during the procedure. The effect is that the patient will be in a sleep like state, whilst still breathing, but with a poor recollection of events once the effect has resolved. 2) Anaesthetist Controlled Anaesthetic: This involves the use of general anaesthetic agents to induce a state of unconsciousness. In most instances this will require the use of an airway device (Laryngeal mask airway or endotracheal tube) to ensure the airway stays open and there is clear flow of oxygen to the lungs. This anaesthesia is given by an Anaesthetist whilst the treating doctor performs the bronchoscopy. Currently the method of sedation is determined by the treating doctor and generally depends on the technical difficulty of the procedure as well as the likelihood of the patient coughing. General anaesthesia being favoured for these cases. In the majority of cases the mode of sedation is decided upon by chance. As we have 2 conscious sedation lists a week and 2 anaesthetic lists per week, whichever list the patient fits into will decide the mode of sedation. Neither of these methods has been shown to be more effective, or shown to be safer than the other. Information regarding patient comfort and satisfaction with either sedation technique has not been collected. We aim to assess comfort and satisfaction during the procedure, so we can determine which is the more favourable for patients, when we offer it in the future. We plan a randomised prospective cohort comparison survey of patients undergoing sedation for a bronchoscopic procedure. Two groups will be compared. Those undergoing conscious sedation versus those undergoing anaesthetist controlled sedation. Patients in both groups will be undergoing both therapeutic and diagnostic procedures. Data collection would involve a short survey prior to the procedure to get an idea of patient expectations, as well as a survey 24-48 hours following the procedure (when the sedation has worn off), to get an idea of what the experience was like. This would involve a phone call from the treating doctor. Other secondary endpoints such as complications and medical staff perception of sedation will also be assessed. In no way will this impact on the procedure the patient would otherwise be having.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62210 0
Dr Joseph Churton
Address 62210 0
Dept of Thoracic Medicine
Royal Brisbane and Women's Hospital
Butterfield St
Herston
QLD 4006
Country 62210 0
Australia
Phone 62210 0
+61403621309
Fax 62210 0
Email 62210 0
[email protected]
Contact person for public queries
Name 62211 0
Dr Joseph Churton
Address 62211 0
Dept of Thoracic Medicine
Royal Brisbane and Women's Hospital
Butterfield St
Herston
QLD 4006
Country 62211 0
Australia
Phone 62211 0
+61403621309
Fax 62211 0
Email 62211 0
[email protected]
Contact person for scientific queries
Name 62212 0
Dr Joseph Churton
Address 62212 0
Dept of Thoracic Medicine
Royal Brisbane and Women's Hospital
Butterfield St
Herston
QLD 4006
Country 62212 0
Australia
Phone 62212 0
+61403621309
Fax 62212 0
Email 62212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Raw procedural data
When will data be available (start and end dates)?
Following any publication. The data will be available up to 5 years after publication.
Available to whom?
Those interested in meta analysis or collaboration
Available for what types of analyses?
Meta analyses
How or where can data be obtained?
The primary investigator. Email: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.