Effect of Push-Dose Adrenaline on Peri-intubation Hypotension During Rapid Sequence Intubation in the Emergency Department

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarmara University Pendik Training and Research Hospital

About this trial

Rapid sequence intubation is commonly performed in the emergency department to secure the airway of critically ill patients. However, blood pressure may decrease during or shortly after intubation because of the patient's underlying illness, the effects of induction medications, and the transition to positive-pressure ventilation. This complication is known as peri-intubation hypotension and is associated with worse clinical outcomes.

This study will evaluate whether a preemptive low dose of intravenous adrenaline, also known as epinephrine, can reduce peri-intubation hypotension in adult emergency department patients undergoing rapid sequence intubation. Participants will be randomly assigned to receive either 10 mcg of intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction. The study will compare hemodynamic changes, vasopressor requirements, safety outcomes, and mortality between the two groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 18 years or older

Patients in the emergency department for whom the treating physician has made a clinical decision to perform rapid sequence intubation

Patients who are hypotensive, defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg, or who are considered to be at significant risk of hypotension during rapid sequence intubation

Written informed consent obtained from the patient or from a legally authorized representative when the patient lacks decision-making capacity

Disqualifiers

Pregnancy

Known allergy to adrenaline

Known contraindication to adrenaline administration

Withdrawal of consent by the patient or legally authorized representative after enrollment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adrenaline

    Drug

    Participants receive 10 mcg of intravenous adrenaline, administered as 1 mL of a 10 mcg/mL dilution, immediately before the administration of induction agents for rapid sequence intubation.

  • 0.9 % sodium chloride

    Drug

    Participants receive 1 mL of 0.9% sodium chloride intravenously as placebo immediately before the administration of induction agents for rapid sequence intubation. The placebo syringe is identical in volume and appearance to the adrenaline syringe.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Push dose adrenalineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peri-intubation hypotension

Peri-intubation hypotension will be defined as the occurrence of systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg at any time during the first 60 minutes after intubation. The incidence of peri-intubation hypotension will be compared between the adrenaline and placebo groups.

Time frame
Within 60 minutes after intubation

Secondary outcomes

1

Change in mean arterial pressure from baseline

Mean arterial pressure will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation. Changes from baseline will be compared between the adrenaline and placebo groups.

Time frame
Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
2

Change in heart rate from baseline

Heart rate will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation. Changes from baseline will be compared between the adrenaline and placebo groups.

Time frame
Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
3

Post-intubation vasopressor requirement

The need for continuous vasopressor infusion after intubation will be recorded. Total vasopressor dose administered during the first hour and the first 24 hours after intubation will be compared between the adrenaline and placebo groups.

Time frame
1 hour and 24 hours after intubation
4

Adverse events

Adverse events including reactive hypertension, cardiac arrest, mortality

Time frame
Within 24 hours after intubation

Other outcomes

Sponsors and contacts

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