Rapid-sequence intubation is routinely performed in critically ill patients. It is unclear whether different sedative agents may influence short-term outcomes after intubation, specially hemodynamic stability.
The optimal and safest hypnotic agent for rapid sequence intubation in critically ill patients remains uncertain. Factors such as hypovolemia, vasoplegia, hypoxemia, and acidosis can influence the efficacy and safety of induction agents. Propofol is commonly used for this purpose; however, it is associated with the risk of exacerbating hypotension. Ketamine, which has a more favorable hemodynamic profile, may offer a safer alternative in these patients. Objective: To assess whether ketamine is a safer alternative to propofol for rapid sequence intubation by reducing the incidence of hypotension during induction in critically ill patients. Methods: This will be a randomized, open-label, pragmatic, bicenter study. A total of 170 critically ill patients requiring endotracheal intubation in the intensive care unit will be randomly assigned to receive either ketamine or propofol as the hypnotic agent. Randomization will be conducted using RedCap with a 1:1 ratio and variable block sizes, stratified by study site and vasopressor use during intubation. Results: The primary outcome will be the occurrence of hypotension, defined as the lowest mean arterial pressure recorded within the first 10 minutes following induction. Secondary outcomes, assessed within 1 hour post-induction, include mortality, incidence of cardiopulmonary arrest, the occurrence of severe hypotension (systolic blood pressure \<80mmHg), the occurrence of severe hypoxemia (oxygen saturation \< 85%), and the number of intubation attempts. Conclusion: The PROMINE study will provide valuable evidence to guide the selection of hypnotic agents for rapid sequence intubation in critically ill patients. It will contribute to a better understanding of the hemodynamic effects associated with propofol and ketamine in this context, potentially informing clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
2 mg per kilogram of body weight
1.5 mg per kilogram of body weight
Federal University of São Paulo
São Paulo, São Paulo, Brazil
Lowest mean blood pressure
Lowest mean blood pressure
Time frame: Ten minutes after induction
Average MAP within the first hour after induction
Average MAP within the first hour after induction
Time frame: 1 hour
Early death
Death within one hour of intubation
Time frame: 01 hour
Cardiac arrest
Cardiac arrest requiring resuscitation
Time frame: 01 hour
Severe hypotension
Systolic blood pressure below 80 mmHg
Time frame: 01 hour
Severe hypoxemia
Peripheral oxygen saturation below 85%
Time frame: 01 hour
Time for successful intubation
Time for successful intubation
Time frame: 01 hour
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