Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001515482
Ethics application status
Approved
Date submitted
30/10/2016
Date registered
3/11/2016
Date last updated
9/11/2021
Date data sharing statement initially provided
23/04/2019
Date results information initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient experience of endotracheal suction
Scientific title
The endotracheal tube and endotracheal suction:
An exploration of the patient experience in:
Adult Cardiac Surgical Intensive Care patients.
Secondary ID [1] 290032 0
None
Universal Trial Number (UTN)
U1111-1186-9357
Trial acronym
None
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Cardiac surgery 300069 0
Endotracheal Tube 300070 0
Endotracheal suction 300071 0
Condition category
Condition code
Surgery 299953 299953 0 0
Other surgery
Cardiovascular 299954 299954 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a qualitative study, investigating the patient experience of the endotracheal tube and endotracheal suction. The intervention is a patient interview prior to discharge. The interview will take approximately 15-30 minutes and will be conducted on day 4-6 post-operatively .
The suction will be performed both when the patient is sedated and awake prior to extubation. This is standard care in post operative cardiac surgical patients. Patients will have pain relief as required.
Intervention code [1] 295753 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299442 0
Patient experience of the endotracheal tube and endotracheal suction. This qualitative study will be assessed by semi-structured interview following surgery and prior to discharge.
Timepoint [1] 299442 0
4-6 days post op
Secondary outcome [1] 327157 0
Pain assessment. This will be assessed with both a validated behavioral pain scale while the patient is sedated and once the patient is awake a validated numerical pain scale will be used. Patient self reported scores are the gold standard for pain assessment and management. The validated behavioral pain tool used will be Critical Care Pain Observation Tool.
Timepoint [1] 327157 0
During endotracheal suction, while sedated and ventilated and during suction once the patient is awake but intubated.

Eligibility
Key inclusion criteria
1. 16 years old and over
2. Patients who have had cardiac surgery with cardiopulmonary bypass (CPB),
3. Extubation within 12 hours of admission to CVICU.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ventilated for over 12 hours.
2. Non-English speaking
3. Documented chronic pain

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Thematic analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/11/2016
Actual
30/01/2017
Date of last participant enrolment
Anticipated
31/01/2017
Actual
21/03/2017
Date of last data collection
Anticipated
28/02/2017
Actual
21/03/2017
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 8144 0
New Zealand
State/province [1] 8144 0
Auckland

Funding & Sponsors
Funding source category [1] 294398 0
Government body
Name [1] 294398 0
Health Research Council, New Zealand - Scholarship funding
Country [1] 294398 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Park Road,
Grafton
Auckland 1048
Country
New Zealand
Secondary sponsor category [1] 293246 0
None
Name [1] 293246 0
Address [1] 293246 0
Country [1] 293246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295821 0
Health and Disabilities Ethis Committee
Ethics committee address [1] 295821 0
Health and Disability Ethics Committees
Ministry of Health Freyberg Building 20 Aitken Street PO Box 5013 Wellington 6011
Ethics committee country [1] 295821 0
New Zealand
Date submitted for ethics approval [1] 295821 0
26/09/2016
Approval date [1] 295821 0
17/10/2016
Ethics approval number [1] 295821 0
16/STH/159

Summary
Brief summary
The aim of this study is to investigate the patient experience of both the endotracheal tube and endotracheal suction. In addition there will be a comparison of two pain assessment tools while the patient is in intensive care.
Trial website
NA
Trial related presentations / publications
None
Public notes
Attachments [1] 1204 1204 0 0
/AnzctrAttachments/371387-HDEC_Letter_-_16STH159_-_Approved_with_non-standard_conditions.pdf.pdf (Ethics approval)
Attachments [2] 1205 1205 0 0
/AnzctrAttachments/371387-Qualitative proposal_EG_Final (2).pdf (Protocol)

Contacts
Principal investigator
Name 68606 0
Ms Eileen Gilder
Address 68606 0
CVICU, Ward 48,
Auckland City Hospital
Park Road
PO Box 110147
1148
Country 68606 0
New Zealand
Phone 68606 0
+64 9 375 7100
Fax 68606 0
Email 68606 0
egilder@adhb.govt.nz
Contact person for public queries
Name 68607 0
Eileen Gilder
Address 68607 0
CVICU, Ward 48,
Auckland City Hospital
Park Road
PO Box 110147
1148
Country 68607 0
New Zealand
Phone 68607 0
+64 9 375 7100
Fax 68607 0
Email 68607 0
egilder@adhb.govt.nz
Contact person for scientific queries
Name 68608 0
Eileen Gilder
Address 68608 0
CVICU, Ward 48,
Auckland City Hospital
Park Road
PO Box 110147
1148
Country 68608 0
New Zealand
Phone 68608 0
+64 9 375 7100
Fax 68608 0
Email 68608 0
egilder@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gilder E, Jull A, Slark J, Parke RL. Patient's ex... [More Details]

Documents added automatically
No additional documents have been identified.