Critical Illness
Conditions
Interventions
This is a single-center, randomized, placebo-controlled, double-blind, two-arm pilot clinical trial. One hundred adult patients requiring rapid sequence intubation will be randomized in a 1:1 ratio us
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults of both sexes; aged 18 years or older; with an indication for orotracheal intubation by rapid sequence intubation in the emergency department
Exclusion criteria
Exclusion criteria: Documented allergy or contraindication to fentanyl; mean arterial pressure equal to or below 65 mmHg despite initial resuscitation; peripheral oxygen saturation below 80% despite optimized preoxygenation; need for immediate intubation that precludes the time required for randomization; decision by the attending physician that fentanyl premedication is clinically required or contraindicated; participation in another research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected primary outcome 1: To assess the overall feasibility of conducting the Fentanyl in Rapid Sequence Intubation in Emergencies trial protocol, defined as the ability to fully and safely execute every step of a randomised, double blind, placebo controlled trial during rapid sequence intubation in an emergency department. Assessed through the combined application of four prespecified operational metrics, measured at the end of the recruitment period: monthly recruitment rate, proportion of eligible patients actually randomised, fidelity of intervention administration and completeness of essential data for the first 30 minutes after intubation | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Secondary Outcome 1: To assess, on an exploratory basis, the incidence of each individual component of the composite clinical outcome within the first 30 minutes after intubation. Assessed by separate recording of the occurrence of peripheral oxygen saturation below 80%, of new haemodynamic instability and of cardiac arrest, documenting the time of occurrence relative to the start of laryngoscopy;Expected Secondary Outcome 2: To assess, on an exploratory basis, the physiological outcomes of the peri intubation period. Assessed by serial recording of blood pressure and peripheral oxygen saturation during the first 30 minutes after intubation. The proportion of participants with hypoxaemia defined as peripheral oxygen saturation below 93%, the proportion with hypotension defined as systolic blood pressure below 90 millimetres of mercury or a fall of 10% or more from baseline, the proportion with hypertension defined as systolic blood pressure above 160 millimetres of mercury or a rise of 10% or more from baseline, and blood pressure variation expressed as the difference between the highest and the lowest systolic blood pressure recorded in the period will be analysed ;Expected Secondary Outcome 3: To assess, on an exploratory basis, the duration of organ support requirements. Assessed by collecting from the electronic health record the periods of invasive mechanical ventilation and of vasopressor use from the index intubation until day 28 or hospital discharge. Ventilator free days and vasopressor free days up to day 28 will be analysed and expressed as median with interquartile range in each allocation group, with death during the period counted as zero free days ;Expected Secondary Outcome 4: To assess, on an exploratory basis, participant mortality. Assessed by review of the electronic health record and of hospital death records until day 28 or hospital discharge, whichever occurs first. All cause in hospital mortality up to 28 days in each allocation gr | — |
Countries
BR
Contacts
Public ContactMatheus Silva
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed