Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000140550
Ethics application status
Approved
Date submitted
27/12/2023
Date registered
14/02/2024
Date last updated
14/02/2024
Date data sharing statement initially provided
14/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intubation of patients with drug overdose
Scientific title
An Overview of Intubations for Drug Overdose at Gold Coast Hospital and Health Service:
A Retrospective Cohort/Descriptive Study
Secondary ID [1] 311248 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
drug overdose 332469 0
Condition category
Condition code
Emergency medicine 329163 329163 0 0
Other emergency care
Injuries and Accidents 329308 329308 0 0
Poisoning

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Intubated overdose patients - intubated for under 12 hours. This is retrospective and on review of the electronic medical records. There is no participant involvement.

The group is defined as those who were intubated for less than 12 hours. This is in consultation with other experts in this area and based on clinical reasoning.

Observations include:
- demographics (age, sex)
- medical history (existing medical issues)
- overdose history (agent, dose, polypharmacy)
- airway management (pre-intubation management e.g. NRB)
- relevant investigations (ECG, CXR, CTB, VBG etc)
- complications during intubation (aspiration, pneumonia etc)
- interventions (charcoal, antidote, ECMO etc)
- outcomes (length of stay ICU and hospital, mortality, complications)

Patients were observed until discharge from hospital
Intervention code [1] 327704 0
Diagnosis / Prognosis
Comparator / control treatment
Intubated overdose patients - intubated for 12 hours or more. This is retrospective and on review of the electronic medical records. There is no participant involvement.

The group is defined as those who were intubated for more than 12 hours. This is in consultation with other experts in this area and based on clinical reasoning.

This group is being compared to the <12 hour group.

Observations include:
- demographics (age, sex)
- medical history (existing medical issues)
- overdose history (agent, dose, polypharmacy)
- airway management (pre-intubation management e.g. NRB)
- relevant investigations (ECG, CXR, CTB, VBG etc)
- complications during intubation (aspiration, pneumonia etc)
- interventions (charcoal, antidote, ECMO etc)
- outcomes (length of stay ICU and hospital, mortality, complications)

Patients were observed until discharge from hospital
Control group
Active

Outcomes
Primary outcome [1] 336991 0
Length of hospital stay
Timepoint [1] 336991 0
within hospital admission
Secondary outcome [1] 430336 0
Length of time to extubation, hours
Timepoint [1] 430336 0
during hospital admission
Secondary outcome [2] 430811 0
Admission to ICU
Timepoint [2] 430811 0
During hospital stay
Secondary outcome [3] 430812 0
Mortality
Timepoint [3] 430812 0
During hospital admission
Secondary outcome [4] 430813 0
Morbidity (aspiration, renal failure, cardiac arrest, hypotension, hypoxia, ED extubation etc)
Timepoint [4] 430813 0
During hospital admission

Eligibility
Key inclusion criteria
Patients with drug overdose intubated in the emergency department between January 2021 to May 2023. Please note that all data collected retrospectively.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intubated pre-hospital
Intubated for indication other than drug overdose e.g. trauma
Transfer from another facility
Age <18
Patients not intubated

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/08/2022
Date of last participant enrolment
Anticipated
17/03/2024
Actual
Date of last data collection
Anticipated
17/03/2024
Actual
Sample size
Target
170
Accrual to date
170
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315505 0
Hospital
Name [1] 315505 0
Gold Coast University Hospital - in-kind support - all funding in-kind by team working for the hospital i.e. during working hours
Country [1] 315505 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard, QLD, 4215, Australia
Country
Australia
Secondary sponsor category [1] 317585 0
None
Name [1] 317585 0
Address [1] 317585 0
Country [1] 317585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314408 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 314408 0
Ethics committee country [1] 314408 0
Australia
Date submitted for ethics approval [1] 314408 0
Approval date [1] 314408 0
02/08/2022
Ethics approval number [1] 314408 0

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

Contacts
Principal investigator
Name 131474 0
Dr Richard A F Pellatt
Address 131474 0
Gold Coast University Hospital, 1 Hospital Boulevard, QLD, 4215, Australia
Country 131474 0
Australia
Phone 131474 0
+61 1300 744 284
Fax 131474 0
Email 131474 0
[email protected]
Contact person for public queries
Name 131475 0
Richard A F Pellatt
Address 131475 0
Gold Coast University Hospital, 1 Hospital Boulevard, QLD, 4215, Australia
Country 131475 0
Australia
Phone 131475 0
+61 1300 744 284
Fax 131475 0
Email 131475 0
[email protected]
Contact person for scientific queries
Name 131476 0
Richard A F Pellatt
Address 131476 0
Gold Coast University Hospital, 1 Hospital Boulevard, QLD, 4215, Australia
Country 131476 0
Australia
Phone 131476 0
+61 1300 744 284
Fax 131476 0
Email 131476 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21298Study protocol    387104-(Uploaded-17-01-2024-13-50-04)-Study-related document.pdf
21299Ethical approval    387104-(Uploaded-17-01-2024-13-56-34)-Study-related document.pdf



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.