ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001491459

Ethics application status

Approved

Date submitted

24/08/2016

Date registered

27/10/2016

Date last updated

27/10/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Ketamine in Acute Behavioural Disturbance

Scientific title

Ketamine in Acute Behavioural Disturbance: The Safety and Effectiveness of Ketamine for sedation of patients with acute behavioural disturbance during aeromedical retrieval

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1186-7805

Trial acronym

KIA

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Behavioural Disturbance

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The study will be evaluating the use of intravenous ketamine to chemically restrain patients with acute behavioural disturbance during aeromedical retrieval. Participants will be followed up for upto 30 minutes post-handover to the recieving healthcare facility. All data will be colected by a restrospective chart audit of electronic databases at RFDS,Queensland and LifeFlight,Queensland.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Proportion of participants who were endotracheal intubated which will be assessed by a retrospective review of medical records at RFDS,Queensland and LifeFlight,Queensland.

Timepoint [1]

At any point during aeromedical retrieval upto 30minutes after participant handover to the receiving healthcare facility

Secondary outcome [1]

Proportion of participants who develop cardiovascular, respiratory or ketamine-specific adverse reactions which will be assessed by a retrospective review of medical records at RFDS,Queensland and LifeFlight,Queensland.

Timepoint [1]

At any point during aeromedical retreival upto 30minutes after participant handover to the receiving healthcare facility

Eligibility

Key inclusion criteria

All participants with acute behavioural disturbance needing aeromedical retrieval between January 1,2015 and June 30,2016

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

All participants who received ketamine for an indication other than chemical restraint i.e. analgesia and intubation

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Retrospective

Statistical methods / analysis

Data abstraction will be done by study authors whilst adhering to standard chart review guidelines including abstractor training, explicit eligibility criteria, precise definition of variables, standardized abstraction forms, periodic meetings and performance monitoring. Interrater reliability will be tested by a blinded review of a random sample of 15% of the charts by the principal investigator and will be measured using the -statistic. The abstractors will not be blinded to the study hypothesis as they are co-investigators of this study and are closely involved in its design and conduct. The data will be abstracted from the patient records after de-identification using a standardized data abstraction form and procedures manual . Any data conflicts during data abstraction due to ambiguous, conflicting or erroneous data will be resolved by periodic meetings and consensus between the abstractors VG, ML, LB, KH, MW and AP.Missing data will be managed by imputation.
The collected data will be analyzed using SPSS 22.0 and descriptive and comparative statistics will be calculated. Continuous variables will be tested for normality. Based on the outcome of the test, parametric Student’s T test or non-parametric Mann-Whitney test will be carried out to determine the differences in data. Categorical data will be analyzed using the Chi-squared analysis. P-values and confidence intervals will be used to determine statistical significance. A p value < 0.05 and 95% confidence intervals that do not overlap unity will be considered statistically significant.

The investigators have not performed a formal sample size calculation due to the the difficulty in estimating the number of patients who could have received ketamine during the study period due to the absence of any previous descriptive studies at LifeFlight. The sample size of 100 is a conservative estimate based partly on a 2014 study at RFDS,Queensland (Le Cong et al A Ketamine Protocol and Intubation Rates for Psychiatric Air Medical Retrieval
Air Medical Journal ). Rather, the investigators plan to identify all the relevant participants during the study period and analyse the data to generate hypotheses which can then be tested in a prospective study.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

28/10/2016

Actual

Date of last participant enrolment

Anticipated

18/11/2016

Actual

Date of last data collection

Anticipated

30/11/2016

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Vinay Gangathimmaiah

Address [1]

Lifeflight Australia, Townsville Base, Hangar 5, Avro Drive,Garbutt Queensland 4811

Country [1]

Australia

Primary sponsor type

Individual

Name

Vinay Gangathimmaiah

Address

Lifeflight Australia, Townsville Base, Hangar 5, Avro Drive,Garbutt Queensland 4811

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Queensland University Human Research Ethics Committee

Ethics committee address [1]

1/538 Flinders Street,Townsville city, QLD 4810

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/07/2016

Approval date [1]

26/07/2016

Ethics approval number [1]

H16/07-200

Summary

Brief summary

Acute behavioural disturbance(ABD), also known as Excited Delirium Syndrome(ExDS), is a medical emergency with reported mortality of 8-10%.. The management of ABD usually necessitates a judicious combination of de-escalation techniques, physical restraints and sedation. Sedation of patients with ABD is usually accomplished with benzodiazepines and antipsychotics, either alone or in combination. The use of these two drug classes can be limited by several factors, primarily respiratory depression with benzodiazepines and a delayed onset of action of up to 20min with antipsychotics. In recent years, several small studies have explored the suitability of ketamine as an alternative agent for sedating patients with ABD in the prehospital, retrieval and emergency settings. Favourable pharmacological properties including rapid onset of action of 2-5min, protection of airway reflexes and maintenance of respiratory drive make ketamine a promising sedative agent in the management of ABD. Nevertheless insufficient data about effectiveness and safety of ketamine in the setting of ABD have prevented it from gaining widespread acceptance for this indication. Firstly, the effectiveness of ketamine sedation in ABD, as measured by sedation failure rates, has varied between no failures in one retrospective study and 10% in a recent prospective study. Furthermore, the reported incidence of endotracheal intubations with ketamine has also varied widely between studies, from no intubations to 39% . Interestingly, a large study looking at the incidence of intubations before and after introduction of a ketamine sedation protocol for ABD found a decrease in incidence from 3.5% to 2.3% while a smaller study using a combination of sedatives including ketamine also reported an intubation rate of 3%. Finally, there is a lack of clarity about the minimum effective ketamine dose needed to achieve safe sedation of behaviorally disturbed patients with reported dose ranges of 0.5-1mg/kg as the initial intravenous dose followed by 1 - 5.56mg/kg/h  intravenous infusion and 2.25- 9.42mg/kg as the total intramuscular dose.

Along with benzodiazepines and antipsychotics, ketamine has been a part of the Standard Operating Procedure(SOP) for management of ABD at Lifeflight Retrieval Medicine(           previously known as Careflight Retrieval Medicine, Queensland),Australia for over 3 years and Royal Flying Doctor Service(RFDS), Queensland, Australia for over 9 years. We want to examine the experience at these organizations to address our research question of whether ketamine is a safe and effective alternative agent for sedation of patients with acute behavioural disturbance in the aeromedical retrieval setting. Our study hypothesis is that in our aeromedical retrieval setting ketamine reduces the incidence of intubations in patients needing sedation for acute behavioural disturbance compared to the reported incidence of intubations in existing literature.

Trial website

Trial related presentations / publications

Public notes

Study recruitment sites:
1.LifeFlight,Queensland.
2.Royal Flight Doctor Service,Queensland.

Attachments [1]

/AnzctrAttachments/371353-KIA Data Abstraction Procedures and Coding Manual Version 2.0.docx (Supplementary information)

Attachments [2]

/AnzctrAttachments/371353-KIA Study Data Abstraction form Version 2.0.docx (Supplementary information)

Attachments [3]

/AnzctrAttachments/371353-Maguire_H1607-200_Low Risk Approved.pdf (Ethics approval)

Attachments [4]

/AnzctrAttachments/371353(v25-10-2016-17-34-53)-KIA protocol version 2.0.docx

Contacts

Principal investigator

Name

Dr Vinay Gangathimmaiah

Address

LifeFlight Australia, Hangar 5,Avro Drive, Garbutt, Queensland 4814

Country

Australia

Phone

+61432650840

Fax

[email protected]

Contact person for public queries

Name

Vinay Gangathimmaiah

Address

LifeFlight Australia,Hangar 5,Avro Drive, Garbutt, Queensland 4814

Country

Australia

Phone

+61432650840

Fax

[email protected]

Contact person for scientific queries

Name

Vinay Gangathimmaiah

Address

LifeFlight Australia,Hangar 5,Avro Drive, Garbutt, Queensland 4814

Country

Australia

Phone

+61432650840

Fax

[email protected]

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.

Trial Review

Documents added manually

Documents added automatically