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Trial registered on ANZCTR


Registration number
ACTRN12615001125516
Ethics application status
Approved
Date submitted
14/10/2015
Date registered
26/10/2015
Date last updated
14/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The QUIET Study Quality Sleep Using ear plugs in the Intensive CarE UniT: A Pilot Randomised Controlled Trial
Scientific title
The feasibility of using earplugs compared with standard care without earplugs as a treatment for improving sleep in patients admitted to the ICU: A pilot randomised controlled trial
Secondary ID [1] 287660 0
none
Universal Trial Number (UTN)
Trial acronym
The QUIET Study
Quality Sleep Using ear plugs in the Intensive CarE UniT:

Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 296492 0
Delirium 296493 0
critical illness 296543 0
Condition category
Condition code
Neurological 296754 296754 0 0
Other neurological disorders
Mental Health 296806 296806 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to postoperative placement of earplugs in ICU
Trial participants randomised to receive ear plugs will have ear plugs placed within 30 minutes of arrival in the ICU from the operating theater. Ear plugs will remain in situ until a clinical decision has been made to either reduce or cease sedative agents with the objective of allowing the patient to regain consciousness, to assess neurological status, or otherwise at the request of the treating clinician or bedside nurse. Ear plugs will be reinserted if a clinical decision is made for the dose of the sedative agents to be increased or to achieve a deeper level of sedation or at the end of neurological assessment.
It is normal practice for the treating clinician to order reduction or cessation in the administration of sedation in conjunction with the gradual reduction in mechanical ventilatory assistance via an endotracheal tube (weaning of sedation and weaning of ventilation). At the commencement of this period of weaning of sedation or ventilation or both, earplugs will be removed. Following the removal of the patient’s endotracheal tube, earplugs will be reinserted while the patient is admitted to the ICU between the hours of 2200-0600, and at any other time of planned sleep or as requested by the participant. Ear plugs will be removed at any time as requested by the patient or if the patient becomes agitated. All other treatment will be according to standard perioperative care at the direction of the treating team.
The duration of the intervention period is the duration of the ICU stay.
The earplugs to be used are memory foam earplugs to be replaced daily.
Adherence will be monitored using a log of earplug use time.
Intervention code [1] 293054 0
Prevention
Comparator / control treatment
Participants randomised to standard care
For trial participants randomised to standard care, all usual treatments, pre-operative, anaesthetic, surgical and post-operative will be as per the treating team. The provision of earplugs to the patient by staff is prohibited while the patient is in the ICU. This is because ear plugs are neither available nor provided at this time and are being made available by the ICU only to patients who are allocated to receive ear plugs within the trial. Earplugs will not be provided to patients who are otherwise eligible for the study but have declined to participate.
Control group
Active

Outcomes
Primary outcome [1] 296364 0
The primary outcome will be study feasibility. A phase III RCT of ear plugs as a sound abatement strategy in ICU will be deemed feasible if all three of the following criteria are met:
less than or equal to 10% of eligible patients refuse to participate on the basis of concerns over the placement of ear plugs

more than or equal to 90% of patients randomised to receive earplugs receive them in the 6 hour period immediately following postoperative ICU admission

more than or equal to 90% of patients randomised to receive earplugs receive them on the first night in ICU that occurs immediately after extubation

less than or equal to 10% of patients who are randomised to not receive earplugs receive earplugs at any time whilst admitted to the ICU

These outcome criteria will be assessed by review of the study records
Timepoint [1] 296364 0
End of ICU stay
Secondary outcome [1] 318262 0
Time with earplugs placed as a proportion of total time receiving mechanical ventilation
This outcome will be assessed by review of the study and hospital records
Timepoint [1] 318262 0
duration of mechanical ventilation in ICU
Secondary outcome [2] 318263 0
Time with earplugs placed as a proportion of total extubated time in ICU between the hours of 2200-0600
This outcome will be assessed by review of the study records
Timepoint [2] 318263 0
First postoperative night following extubation in ICU
Secondary outcome [3] 318264 0
Quality of sleep self-reported by patient using the Richards-Campbell Sleep Questionnaire
Timepoint [3] 318264 0
First full night (2200-0600) where the patient was not receiving mechanical ventilation
Secondary outcome [4] 318265 0
ICU length of stay
This outcome will be assessed by review of the hospital records
Timepoint [4] 318265 0
ICU discharge
Secondary outcome [5] 318266 0
Hospital length of stay
This outcome will be assessed by review of the hospital records
Timepoint [5] 318266 0
Hospital discharge
Secondary outcome [6] 318267 0
ICU mortality
This outcome will be assessed by review of the hospital records
Timepoint [6] 318267 0
ICU discharge
Secondary outcome [7] 318268 0
Hospital mortality
This outcome will be assessed by review of the hospital records
Timepoint [7] 318268 0
Hospital discharge
Secondary outcome [8] 318269 0
Use of antipsychotic medication in ICU (olanzapine, quetiapine, haloperidol, risperidone)
This outcome will be assessed by review of the hospital records
Timepoint [8] 318269 0
ICU discharge

Eligibility
Key inclusion criteria
1. Listed for elective surgery with a plan for post-operative admission to the ICU while still receiving mechanical ventilation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age <18 years

2. Preexisting hearing difficulties requiring the use of a hearing aid

3. Suspected or confirmed ruptured tympanic membrane

4. Unable or unwilling to have ear plugs placed for sleep promotion whilst in ICU

5. Treating surgeon deems enrolment is not in the best interest of the patient

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
http://www.randomization.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For all estimates, 95% confidence intervals will be reported. For normally distributed data, mean and standard deviation will be reported, for non-normally distributed data, median and inter-quartile range and numbers and proportions for dichotomous and ordinal data. Where data are missing, the number of observations will be reported.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/10/2015
Date of last participant enrolment
Anticipated
1/03/2016
Actual
24/04/2016
Date of last data collection
Anticipated
Actual
24/05/2016
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4454 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 10660 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 292218 0
Hospital
Name [1] 292218 0
St John of God Hospital, Subiaco
Country [1] 292218 0
Australia
Primary sponsor type
Individual
Name
Dr Edward Litton
Address
Intensive Care Unit, St John of God Hospital, 8 Salvado road, Subiaco, 6008, WA
Country
Australia
Secondary sponsor category [1] 290895 0
None
Name [1] 290895 0
Address [1] 290895 0
Country [1] 290895 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293691 0
St John of God Subiaco
Ethics committee address [1] 293691 0
Ethics committee country [1] 293691 0
Australia
Date submitted for ethics approval [1] 293691 0
13/08/2015
Approval date [1] 293691 0
14/09/2015
Ethics approval number [1] 293691 0
863

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 584 584 0 0
/AnzctrAttachments/369478-QUIET Brochure V1 24082015.pdf

Contacts
Principal investigator
Name 60970 0
Dr Edward Litton
Address 60970 0
Intensive Care Unit
St John of God Hospital
8 Salvado road
Subiaco
WA
6008
Country 60970 0
Australia
Phone 60970 0
+61415293281
Fax 60970 0
Email 60970 0
ed_litton@hotmail.com
Contact person for public queries
Name 60971 0
Edward Litton
Address 60971 0
Intensive Care Unit
St John of God Hospital
8 Salvado Road
Subiaco
WA
6008
Country 60971 0
Australia
Phone 60971 0
+61415293281
Fax 60971 0
Email 60971 0
ed_litton@hotmail.com
Contact person for scientific queries
Name 60972 0
Edward Litton
Address 60972 0
Intensive Care Unit
St John of God Hospital
8 Salvado Road
Subiaco
WA
6008
Country 60972 0
Australia
Phone 60972 0
+61415293281
Fax 60972 0
Email 60972 0
ed_litton@hotmail.com

No information has been provided regarding IPD availability


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.