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Trial registered on ANZCTR


Registration number
ACTRN12622001481763
Ethics application status
Approved
Date submitted
18/11/2022
Date registered
25/11/2022
Date last updated
25/11/2022
Date data sharing statement initially provided
25/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The incidence and significance of post-operative respiratory depression amongst surgical patients receiving intrathecal morphine
Scientific title
The incidence and significance of post-operative respiratory depression amongst surgical patients receiving intrathecal morphine
Secondary ID [1] 308356 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Depression Associated with Neuraxial Opioid Administration 328150 0
Condition category
Condition code
Anaesthesiology 325201 325201 0 0
Anaesthetics
Anaesthesiology 325202 325202 0 0
Pain management
Respiratory 325326 325326 0 0
Other respiratory disorders / diseases
Neurological 325327 325327 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will describe the incidence and clinical significance of respiratory depression after the administration of intrathecal morphine amongst adult surgical patients at Austin Health between 2017 and 2022 who were extubated and were admitted to the intensive care or high dependency unit post-operatively.

Data collected will include: patient demographics, comorbidities, surgical details, anaesthetic details, clinical observations, blood gases, laboratory investigations, radiology reports, complications, discharge details and mortality data.

As this is a retrospective study, there is no participant involvement. Data will be collected from the electronic medical records. Participants will be followed up until 90 days post-operatively.
Intervention code [1] 324805 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333036 0
Respiratory depression, defined as documented evidence in the medical record of: respiratory rate < 10 breaths / minute; or arterial oxygen saturation < 90%; or arterial carbon dioxide partial pressure > 50mmHg; or sedation score = 2.
Timepoint [1] 333036 0
24 hours after administration of intrathecal morphine
Primary outcome [2] 333037 0
Post-operative respiratory complications, defined as documented evidence in the medical record of: respiratory infection; respiratory failure; pleural effusion; atelectasis; pneumothorax; bronchospasm; or aspiration pneumonitis.
Timepoint [2] 333037 0
7 days post-operatively
Secondary outcome [1] 415583 0
Respiratory intervention, defined as documented evidence in the medical record of: antibiotic therapy for the treatment of respiratory infection; initiation or up-titration of diuretic therapy; initiation or up-titration of bronchodilator therapy; insertion of intercostal catheter post-operatively; initiation of non-invasive ventilation; or re-intubation (excluding peri-procedural).
Timepoint [1] 415583 0
7 days post-operatively
Secondary outcome [2] 415584 0
Clavien-Dindo III–V complication, defined as documented evidence in the medical record of any complication requiring: surgical intervention; admission to intensive care; or mortality.
Timepoint [2] 415584 0
30 days post-operatively
Secondary outcome [3] 415585 0
Days alive and out of hospital, defined as the sum of all post-operative days both alive and not hospitalised, as recorded in the medical record
Timepoint [3] 415585 0
90 days post-operatively

Eligibility
Key inclusion criteria
Adult patient, greater than or equal to 18 years
Underwent surgery at Austin Health
Received intrathecal morphine
Admitted to the intensive care / high dependency unit post-operatively
Not intubated post-operatively
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intrathecal catheter placement with ongoing infusion of intrathecal opioid

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using Stata/SE version 15.1 (StataCorp, College Station, TX, USA).

The dataset will be analysed for missing data. If the incidence of missing data for a given variable is greater than 5%, the multiple imputation method will be used if the data can be assumed to be missing at random. If the incidence of missing data for a given variable is less than 5%, appropriate statistical analysis will be undertaken. All continuous variables will be tested for normality. Normally distributed variables will be analysed using parametric statistical methods. Non-normally distributed variables will either be transformed and re-evaluated for normality, or analysed using non-parametric statistical methods.

Logistic regression modelling will be used to explore the associations between respiratory depression and the study outcomes: post-operative respiratory complications within 7-days, post-operative respiratory intervention within 7-days, Clavien-Dindo grade III-V complications within 30-days, and days alive and out of hospital at 90-days (DAOH-90) post-operatively. The odds ratios (OR) and 95% confidence intervals (95%CI) will be reported for all associations. Both univariate and multivariate analysis will be performed. Multivariate analysis will adjust for relevant confounders, including: Charlton Comorbidity Index (CCI) score, ARISCAT score, surgical type and/or duration, intrathecal morphine dose, and peri-operative opioid use.

Continuous variables will be reported as mean ± standard deviation (SD) or median [interquartile range]. Categorical variables will be reported as number (percentile). Comparative results with be presented with a P-value and corresponding effect size. A two-tailed P-value of less than 0.05 will be considered statistically significant.

All data will be presented as mean ± standard deviation (SD) or median [IQR] for continuous variables and number (percentile) for categorical variables. Comparative results will be presented with a P-value and corresponding effect size. A two-tailed P-value below 0.050 will be considered to be statistically significant. P-values will be adjusted by Bonferroni’s correction method as required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/07/2020
Date of last participant enrolment
Anticipated
Actual
3/10/2022
Date of last data collection
Anticipated
Actual
3/10/2022
Sample size
Target
700
Accrual to date
Final
698
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23513 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 38921 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 312577 0
Hospital
Name [1] 312577 0
Austin Health – Department of Anaesthesia
Country [1] 312577 0
Australia
Primary sponsor type
Individual
Name
Dr Luke Fletcher
Address
Department of Anaesthesia, Austin Health
145 Studley Road, Heidelberg, VIC, 3084
Country
Australia
Secondary sponsor category [1] 314211 0
Individual
Name [1] 314211 0
Dr Raymond Hu
Address [1] 314211 0
Department of Anaesthesia, Austin Health
145 Studley Road, Heidelberg, VIC, 3084
Country [1] 314211 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311903 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 311903 0
Ethics committee country [1] 311903 0
Australia
Date submitted for ethics approval [1] 311903 0
18/04/2020
Approval date [1] 311903 0
19/05/2020
Ethics approval number [1] 311903 0
Audit/20/Austin/56

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122782 0
Dr Luke Robert Fletcher
Address 122782 0
Department of Anaesthesia, Austin Health
145 Studley Road, Heidelberg, VIC, 3084
Country 122782 0
Australia
Phone 122782 0
+61394965704
Fax 122782 0
Email 122782 0
luke.fletcher@austin.org.au
Contact person for public queries
Name 122783 0
Luke Robert Fletcher
Address 122783 0
Department of Anaesthesia, Austin Health
145 Studley Road, Heidelberg, VIC, 3084
Country 122783 0
Australia
Phone 122783 0
+61394965000
Fax 122783 0
Email 122783 0
luke.fletcher@austin.org.au
Contact person for scientific queries
Name 122784 0
Luke Robert Fletcher
Address 122784 0
Department of Anaesthesia, Austin Health
145 Studley Road, Heidelberg, VIC, 3084
Country 122784 0
Australia
Phone 122784 0
+61394965000
Fax 122784 0
Email 122784 0
luke.fletcher@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will be withheld for privacy and ethical reasons.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17551Ethical approval  luke.fletcher@austin.org.au Available on request



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.