Not Yet RecruitingPhase 3ACTRN12624001418561

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

Sponsor

St Vincent's Hospital (Melbourne) Ltd

Enrollment

50 participants

Start Date

Dec 30, 2024

Study Type

Interventional

Conditions

Critical Care

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Adults requiring emergency tracheal intubation in ICU.

Exclusion Criteria11

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

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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

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.