Ketamine when compared to usual care as induction drugs for tracheal intubation of critically ill patients: A prospective, blinded, parallel-group, randomised, feasibility trial

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001418561

Enrollment

Registered

2024-12-03

Start date

2024-12-30

Completion date

2025-08-30

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Tracheal intubation represents considerable risk in critically ill patients. Hypotension following induction has been found to be associated with increased mortality and hospital length of stay. One of the contributors to hypotension may be the type of induction medication used. Ketamine is widely adopted in the emergency department and pre-hospital setting due to its haemodynamic stability. This feasibility trial will aim to allocate 50 patients (25 in each arm) to receive either ketamine-only induction or usual care. The primary outcome is the area under Mean arterial blood pressure (MAP) less than 65mmHg curve. The results will inform design of larger multi-centre trials and the outcomes that will be studied in the future trials.

Interventions

For patients undergoing emergency tracheal intubation in ICU, induction of anaesthesia will be using intravenous ketamine hydrochloride 1-2mg/kg (ideal body weight). A dedicated scribe will record administration of intubation drugs including the study drug into the Case Report Form during the procedure to ensure adherence to intervention. This will be verified against the dose recorded in the patient's hospital record.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults requiring emergency tracheal intubation in ICU.

Exclusion criteria

1. Age < 18 years old 2. Death during ICU admission deemed inevitable. 3. Patient with Not for Resuscitation/Do not Resuscitate order. 4. Patient is pregnant or suspected to be pregnant. 5. Known allergy or contraindiation to administration of ketamine or propofol. 6. Cardiac arrest where the standard practice is not to use induction medications. 7. Patient with severe hypertension Systolic Blood Pressure > 180mmHg. 8. Patient with known aortic aneurysm or dissection. 9. Patient with known unsecured cerebral aneurysm. 10. Patient previously been enrolled in this study. 11. Clinician deems patient not suitable or participation deemed not in patient's best interests.

Outcome results