Acute Respiratory Failure
Conditions
Keywords
rapid sequence intubation, intubation, airway management, propofol, ketamine, hypnotics
Brief summary
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.
Detailed description
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.
Interventions
DRUGEsketamine
2 mg per kilogram of body weight
DRUGPropofol
1.5 mg per kilogram of body weight
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 18 years old * Physician indicated intubation
Exclusion criteria
* Pregnancy * Intubation during cardiac arrest * Known of suspected intracranial hypertension * Know allergy to any of the study drugs (lidocaine, fentanyl, propofol, ketamine, or rocuronium) * Bradycardia (heart rate below 50 beats per minute) or atrioventricular block without a pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest mean blood pressure | Ten minutes after induction | For the primary outcome, a pre-specified subgroup analysis will evaluate the following groups: patients \< 70 versus ≥ 70 years old; patients with a Sequential Organ Failure Assessment (SOFA) score \< 8 versus ≥ 8 points; patients on vasopressor versus without vasopressors; and patients with acute respiratory distress syndrome (ARDS) versus those without ARDS. Each subgroup analysis will be performed using linear regression, adjusted for baseline MAP before induction, total vasopressor dose in the first 10 minutes, age, and a random patient intercept. Effect estimates will be reported as mean differences with 95%CIs for each subgroup, with respective interaction p values. We will not adjust for multiplicity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average MAP within the first hour after induction | 1 hour | Average MAP within the first hour after induction |
| Early death | 01 hour | Death within one hour of intubation |
| Cardiac arrest | 01 hour | Cardiac arrest requiring resuscitation |
| Severe hypotension | 01 hour | Systolic blood pressure below 80 mmHg |
| Severe hypoxemia | 01 hour | Peripheral oxygen saturation below 85% |
| Time for successful intubation | 01 hour | Time for successful intubation |
Countries
Brazil
Contacts
STUDY_CHAIRFlavia R Machado, MD, PhD
Federal University of São Paulo
PRINCIPAL_INVESTIGATORRaysa Schmidt, MD
Federal University of São Paulo
Outcome results
None listed